Vitamin D and vitamin D analogues for preventing fractures associated with involutional and post-menopausal osteoporosis.

BACKGROUND: Vitamin D and related compounds have been used to prevent fractures. OBJECTIVES: To determine the effects of vitamin D or analogues, with or without calcium, in the prevention of fractures in older people. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group trials register, the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2005), MEDLINE, EMBASE, CINAHL, and reference lists of articles. Most recent search: March 2005. SELECTION CRITERIA: Randomised or quasi-randomised trials comparing vitamin D or an analogue, alone or with calcium, against placebo, no intervention, or calcium, reporting fracture outcomes, in older people. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality, and extracted data. Data were pooled, where admissible, using the fixed-effect model, or random-effects model if the relative risks were heterogeneous. MAIN RESULTS: Vitamin D alone showed no statistically significant effect on hip fracture (seven trials, 18,668 participants, RR 1.17, 95% CI 0.98 to 1.41), vertebral fracture (four trials, 5698 participants, RR (random effects) 1.13, 95% CI 0.50 to 2.55) or any new fracture (eight trials, 18,903 participants, RR 0.99, 95% CI 0.91 to 1.09). Vitamin D with calcium marginally reduced hip fractures (seven trials, 10,376 participants, RR 0.81, 95% CI 0.68 to 0.96), non-vertebral fractures (seven trials, 10,376 participants, RR 0.87, 95% CI 0.78 to 0.97), but there was no evidence of effect of vitamin D with calcium on vertebral fractures. The effect appeared to be restricted to those living in institutional care. Hypercalcaemia was more common when vitamin D or its analogues was given compared with placebo or calcium (14 trials, 8035 participants, RR 2.38, 95% CI 1.52 to 3.71). The risk was particularly high with calcitriol (three trials, 742 participants, RR 14.94, 95% CI 2.95 to 75.61). There was no evidence that vitamin D increased gastro-intestinal symptoms (seven trials, 10,188 participants, RR (random effects) 1.03, 95% CI 0.79 to 1.36) or renal disease (nine trials, 10,107 participants, RR 0.80, 95% CI 0.34 to 1.87). AUTHORS' CONCLUSIONS: Frail older people confined to institutions may sustain fewer hip and other non-vertebral fractures if given vitamin D with calcium supplements. Effectiveness of vitamin D alone in fracture prevention is unclear. There is no evidence of advantage of analogues of vitamin D compared with vitamin D. Calcitriol may be associated with an increased incidence of adverse effects. Dose, frequency, and route of administration of vitamin D in older people require further investigation.

Hip protectors for preventing hip fractures in older people.

BACKGROUND: Hip fracture in older people usually results from a fall on the hip. Hip protectors have been advocated as a means to reduce the risk of sustaining a hip fracture. OBJECTIVES: To determine if external hip protectors reduce the incidence of hip fractures in older people following a fall. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group trials register (January 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2005), MEDLINE (1966 to January Week 2, 2005), EMBASE (1988 to 2005 Week 02), CINAHL (1982 to December Week 2 2004), other databases and reference lists of relevant articles. We also contacted trialists. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing the use of hip protectors with a control group. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We sought additional information from trialists. Pooling of uncorrected data from cluster-randomised trials was only done on an exploratory basis. MAIN RESULTS: Fifteen included trials contributed data to this updated review. One trial, which was a study of compliance (adherence) lasting 12 weeks, contributed no fracture outcome data. Pooling of data from eleven trials conducted in nursing or residential care settings, including six cluster-randomised studies, showed evidence of a marginally statistically significant reduction in hip fracture incidence (relative risk (RR) 0.77, 95% confidence interval (CI) 0.62 to 0.97). This analysis showed significant statistical heterogeneity. Pooling of data from three individually randomised trials involving 5135 community dwelling participants, showed no reduction in hip fracture incidence from the provision of hip protectors (RR 1.16, 95% CI 0.85 to 1.59). There was no evidence of any significant effect of hip protectors on incidence of pelvic or other fractures. No important adverse effects of the hip protectors were reported but compliance, particularly in the long term, was poor. AUTHORS' CONCLUSIONS: Accumulating evidence casts some doubt on the effectiveness of the provision of hip protectors in reducing the incidence of hip in older people. Acceptance and adherence by users of the protectors remain poor due to discomfort and practicality.

Oral vitamin D3 and calcium for secondary prevention of low-trauma fractures in elderly people (Randomised Evaluation of Calcium Or vitamin D, RECORD): a randomised placebo-controlled trial.

BACKGROUND: Elderly people who have a fracture are at high risk of another. Vitamin D and calcium supplements are often recommended for fracture prevention. We aimed to assess whether vitamin D3 and calcium, either alone or in combination, were effective in prevention of secondary fractures. METHODS: In a factorial-design trial, 5292 people aged 70 years or older (4481 [85%] of whom were women) who were mobile before developing a low-trauma fracture were randomly assigned 800 IU daily oral vitamin D3, 1000 mg calcium, oral vitamin D3 (800 IU per day) combined with calcium (1000 mg per day), or placebo. Participants who were recruited in 21 UK hospitals were followed up for between 24 months and 62 months. Analysis was by intention-to-treat and the primary outcome was new low-energy fractures. FINDINGS: 698 (13%) of 5292 participants had a new low-trauma fracture, 183 (26%) of which were of the hip. The incidence of new, low-trauma fractures did not differ significantly between participants allocated calcium and those who were not (331 [12.6%] of 2617 vs 367 [13.7%] of 2675; hazard ratio (HR) 0.94 [95% CI 0.81-1.09]); between participants allocated vitamin D3 and those who were not (353 [13.3%] of 2649 vs 345 [13.1%] of 2643; 1.02 [0.88-1.19]); or between those allocated combination treatment and those assigned placebo (165 [12.6%] of 1306 vs 179 [13.4%] of 1332; HR for interaction term 1.01 [0.75-1.36]). The groups did not differ in the incidence of all-new fractures, fractures confirmed by radiography, hip fractures, death, number of falls, or quality of life. By 24 months, 2886 (54.5%) of 5292 were still taking tablets, 451 (8.5%) had died, 58 (1.1%) had withdrawn, and 1897 (35.8%) had stopped taking tablets but were still providing data for at least the main outcomes. Compliance with tablets containing calcium was significantly lower (difference: 9.4% [95% CI 6.6-12.2]), partly because of gastrointestinal symptoms. However, potentially serious adverse events were rare and did not differ between groups. INTERPRETATION: The findings do not support routine oral supplementation with calcium and vitamin D3, either alone or in combination, for the prevention of further fractures in previously mobile elderly people.

Patient-assessed health instruments for the knee: a structured review.

OBJECTIVES: To identify patient-assessed health instruments specific to the knee and review evidence for reliability, validity and responsiveness. METHODS: Instruments were identified through systematic searches of the literature. Information relating to instrument content, patient population, reliability, validity and responsiveness was extracted from published papers. RESULTS: The 16 instruments that met the inclusion criteria varied in length from 4 to 42 items. The majority form a single index; six produce a profile of scores. Eight have been evaluated in patients with a variety of knee problems. All instruments have satisfactory internal or test-retest reliability. However, there is limited empirical support for the health domains of six instruments. Patients informed the development of items within just five instruments. Few authors gave explicit consideration to the size of expected relationships in tests of construct validity. Eleven instruments have evidence for responsiveness to changes in health. The minimally important difference was not determined for any of the instruments. CONCLUSIONS: In the absence of comparative evidence, the large number of patient-assessed instruments for knee problems makes instrument selection difficult. The Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Pain Scale and Oxford Knee Score have good evidence for reliability, content validity and construct validity. The KOOS and Oxford instruments also have evidence for responsiveness. The instruments have not been evaluated for all knee problems, and instrument appropriateness, including content relevance, must be assessed before application. The comparative evaluation of instruments is recommended.

Hip protectors for preventing hip fractures in the elderly.

BACKGROUND: Hip fracture in the elderly usually results from a fall on the hip. Hip protectors have been advocated as a means to reduce the risk of sustaining a hip fracture. OBJECTIVES: To determine if external hip protectors reduce the incidence of hip fractures in elderly persons following a fall. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group trials register (February 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2004), MEDLINE (1966 to February Week 2 2004), EMBASE (1988 to 2004 Week 08), CINAHL (1982 to February Week 2 2004), other databases and reference lists of relevant articles. We also contacted trialists. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing the use of hip protectors with a control group. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. We sought additional information from all trialists. MAIN RESULTS: An additional trial with 4169 participants was included in this update, giving a total of 14 included trials. One, which was a study of compliance (adherence) lasting 12 weeks, contributed no fracture outcome data. Five studies involving 4316 participants were cluster randomised by care unit, nursing home or nursing home ward rather than by the individual. Each of these studies reported a reduced incidence of hip fractures within those units allocated to receive the protectors. Because the majority of these trials had not been analysed to allow for clustering, pooling of their results was not undertaken. Pooling of data from five individually randomised trials conducted in nursing/residential care settings (1426 participants) showed no significant reduction in hip fracture incidence (hip protectors 37/822, controls 40/604, relative risk (RR) 0.83, 95% confidence interval (CI) 0.54 to 1.29). Three individually randomised trials of 5135 community dwelling participants, reported no reduction in hip fracture incidence with the hip protectors (RR 1.16, 95% CI 0.85 to 1.59). No important adverse effects of the hip protectors were reported but compliance, particularly in the long term, was poor. REVIEWERS' CONCLUSIONS: There is no evidence of effectiveness of hip protectors from studies in which randomisation was by individual patient within an institution, or for those living in their own homes. Data from cluster randomised studies indicate that, for those living in institutional care with a high background incidence of hip fracture, a programme of providing hip protectors appears to reduce the incidence of hip fractures. Acceptability by users of the protectors remains a problem, due to discomfort and practicality.

Antibiotics for preventing infection in open limb fractures.

BACKGROUND: Wound and bone infections are frequently associated with open fractures of the extremities and may add significantly to the resulting morbidity. The administration of antibiotics is routinely used in developed countries as an adjunct to a comprehensive management protocol that also includes irrigation, surgical debridement and stabilisation when indicated, and is thought to reduce the frequency of infections. OBJECTIVES: To quantify the evidence for the effectiveness of antibiotics in the initial treatment of open fractures of the limbs. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register (April 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library issue 1, 2003), MEDLINE (1966 to April 2003), EMBASE (1988 to April 2003), LILACS (1992 to June 2002) and reference lists of articles. Proceedings of meetings of the American Academy of Orthopaedic Surgeons (1980 to 2001), the Orthopaedic Trauma Association (1990 to 2001) and the Société Internationale de Chirurgie Orthopedique et Traumatologique (1980 to 2001) were hand searched. We also contacted published researchers in the field. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials involving: participants - people of any age with open fractures of the limbs; intervention - antibiotic administered before or at the time of primary treatment of the open fracture compared with placebo or no antibiotic; outcome measures - early wound infection, chronic drainage, acute or chronic osteomyelitis, delayed unions or non-unions, amputations and deaths. DATA COLLECTION AND ANALYSIS: Two reviewers independently screened papers for inclusion, assessed trial quality using an eight item scale, and extracted data. Additional information was sought from three trialists. Pooled data are presented graphically. MAIN RESULTS: Data from 913 participants in seven studies were analysed. The use of antibiotics had a protective effect against early infection compared with no antibiotics or placebo (relative risk 0.41 (95% confidence interval (CI) 0.27 to 0.63); absolute risk reduction 0.08 (95% CI 0.04 to 0.12); NNT 13 (95% CI 8 to 25)). There were insufficient data in the included studies to evaluate other outcomes. REVIEWER'S CONCLUSIONS: Antibiotics reduce the incidence of early infections in open fractures of the limbs. Further placebo controlled randomised trials are unlikely to be justified in middle and high income countries. Further research is necessary to the determine the avoidable burden of morbidity in countries where antibiotics are not used routinely in the management of open fractures.

Interventions for preventing falls in elderly people.

BACKGROUND: Approximately 30 per cent of people over 65 years of age and living in the community fall each year; the number is higher in institutions. Although less than one fall in 10 results in a fracture, a fifth of fall incidents require medical attention. OBJECTIVES: To assess the effects of interventions designed to reduce the incidence of falls in elderly people (living in the community, or in institutional or hospital care). SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Group specialised register (January 2003), Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2003), MEDLINE (1966 to February 2003), EMBASE (1988 to 2003 Week 19), CINAHL (1982 to April 2003), The National Research Register, Issue 2, 2003, Current Controlled Trials (www.controlled-trials.com accessed 11 July 2003) and reference lists of articles. No language restrictions were applied. Further trials were identified by contact with researchers in the field. SELECTION CRITERIA: Randomised trials of interventions designed to minimise the effect of, or exposure to, risk factors for falling in elderly people. Main outcomes of interest were the number of fallers, or falls. Trials reporting only intermediate outcomes were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Data were pooled using the fixed effect model where appropriate. MAIN RESULTS: Sixty two trials involving 21,668 people were included. Interventions likely to be beneficial: Multidisciplinary, multifactorial, health/environmental risk factor screening/intervention programmes in the community both for an unselected population of older people (4 trials, 1651 participants, pooled RR 0.73, 95%CI 0.63 to 0.85), and for older people with a history of falling or selected because of known risk factors (5 trials, 1176 participants, pooled RR 0.86, 95%CI 0.76 to 0.98), and in residential care facilities (1 trial, 439 participants, cluster-adjusted incidence rate ratio 0.60, 95%CI 0.50 to 0.73) A programme of muscle strengthening and balance retraining, individually prescribed at home by a trained health professional (3 trials, 566 participants, pooled relative risk (RR) 0.80, 95% confidence interval (95%CI) 0.66 to 0.98) Home hazard assessment and modification that is professionally prescribed for older people with a history of falling (3 trials, 374 participants, RR 0.66, 95% CI 0.54 to 0.81) Withdrawal of psychotropic medication (1 trial, 93 participants, relative hazard 0.34, 95%CI 0.16 to 0.74) Cardiac pacing for fallers with cardioinhibitory carotid sinus hypersensitivity (1 trial, 175 participants, WMD -5.20, 95%CI -9.40 to -1.00) A 15 week Tai Chi group exercise intervention (1 trial, 200 participants, risk ratio 0.51, 95%CI 0.36 to 0.73). Interventions of unknown effectiveness: Group-delivered exercise interventions (9 trials, 1387 participants) Individual lower limb strength training (1 trial, 222 participants) Nutritional supplementation (1 trial, 46 participants) Vitamin D supplementation, with or without calcium (3 trials, 461 participants) Home hazard modification in association with advice on optimising medication (1 trial, 658 participants), or in association with an education package on exercise and reducing fall risk (1 trial, 3182 participants) Pharmacological therapy (raubasine-dihydroergocristine, 1 trial, 95 participants) Interventions using a cognitive/behavioural approach alone (2 trials, 145 participants) Home hazard modification for older people without a history of falling (1 trial, 530 participants) Hormone replacement therapy (1 trial, 116 participants) Correction of visual deficiency (1 trial, 276 participants). Interventions unlikely to be beneficial: Brisk walking in women with an upper limb fracture in the previous two years (1 trial, 165 participants). REVIEWER'S CONCLUSIONS: Interventions to prevent falls that are likely to be effective are now available; less is known about their effectiveness in preventing fall-related injuries. Costs per fall prevented have been established for four of the interventions and careful economic modelling in the context of the local healthcare system is important. Some potential interventions are of unknown effectiveness and further research is indicated.

Hip protectors for preventing hip fractures in the elderly.

BACKGROUND: Hip fracture in the elderly is usually the result of a simple fall. Hip protectors have been advocated as a means to reduce the risk of sustaining a fracture in a fall on the hip. OBJECTIVES: To determine if external hip protectors reduce the incidence of hip fractures in elderly persons following a fall. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group trials register (April 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2003), MEDLINE (1966 to April 2003), EMBASE (1988 to 2003 week 14), CINAHL (1982 to April 2003) and reference lists of relevant articles. Trialists were contacted, and ongoing trials identified in The National Research Register (http://www.update-software.com/national/ accessed 20/01/03) and Current Controlled Trials (http://controlled-trials.com/ accessed 20/01/03). SELECTION CRITERIA: All randomised or quasi-randomised controlled trials (RCTs) comparing the use of hip protectors with a control group. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality, using a 10-item scale, and extracted data. Additional information was sought from all trialists. Wherever appropriate and possible, the data are presented graphically. MAIN RESULTS: In this third update, 13 randomised controlled trials were included. One, which was a study of compliance lasting 12 weeks, contributed no fracture outcome data. Five studies involving 4316 participants were cluster randomised by care unit, nursing home or nursing home ward rather than by the individual. Individually, each of these studies reported a reduced incidence of hip fractures within those units allocated to receive the protectors. Because of the use of cluster randomisation pooling of results of these studies was not undertaken. Pooling of data from five individually randomised trials conducted in nursing/residential care settings (1426 participants) showed no significant reduction in hip fracture incidence (hip protectors 37/822, controls 40/604, RR 0.83, 95% CI 0.54 to 1.29). Two individually randomised trials of 966 community dwelling participants, reported no reduction in hip fracture incidence with the hip protectors (RR 1.11, 95% CI 0.65 to 1.90). No important adverse effects of the hip protectors were reported but compliance, particularly in the long term, was poor. REVIEWER'S CONCLUSIONS: There is no evidence of effectiveness of hip protectors from studies in which randomisation was by individual patient within an institution, or for those living in their own homes. Data from cluster randomised studies indicates that, for those living in institutional care with a high background incidence of hip fracture, a programme of providing hip protectors appears to reduce the incidence of hip fractures. Acceptability by users of the protectors remains a problem, due to discomfort and practicality. Cost effectiveness remains unclear.

Heparin, low molecular weight heparin and physical methods for preventing deep vein thrombosis and pulmonary embolism following surgery for hip fractures.

BACKGROUND: Hip fracture patients have a high risk of thrombo-embolic complications following surgical management. OBJECTIVES: To examine the effects of heparin (unfractionated (U), and low molecular weight (LMW) heparins), and physical methods (compression stockings, calf or foot pumps) for prevention of deep venous thrombosis (DVT) and pulmonary embolism after surgery for hip fracture in the elderly. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register (up to March 2002), MEDLINE (1966 to March 2002), EMBASE (1980 to March 2002), CINAHL (1982 to February week 4 2002), Current Contents (1993 week 26 to 2002 week 12), reference lists of published articles and contacted trialists and other workers in the field. Date of most recent search: March 2002. SELECTION CRITERIA: Randomised and quasi-randomised trials evaluating the use of heparins and physical agents for prevention of DVT and pulmonary embolism in patients undergoing surgery for hip fracture. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed methodological quality and extracted data. Trials were grouped into five categories (heparin versus control, mechanical versus control, LMW heparin versus U heparin, heparin versus mechanical, and miscellaneous) and results pooled where possible. MAIN RESULTS: The 31 included trials involved at least 2958 predominantly female and elderly patients. Overall, trial quality was disappointing. Ten trials involving 826 patients which compared U heparin with control, and five trials of 373 patients which compared LMW heparin with control, showed a reduction in the incidence of lower limb DVT (124/474 (26%) versus 219/519 (42%); relative risk (RR) 0.60; 95% confidence interval (CI) 0.50 to 0.71). There were insufficient data to confirm the efficacy of either agent in the prevention of pulmonary embolism. There was no statistically significant difference in overall mortality (42/356 (12%) versus 38/374 (10%); RR 1.16; 95%CI 0.77 to 1.74). Data were inadequate for all other outcomes including wound complications. There is insufficient evidence from five trials, involving 644 patients, to establish if LMW heparin was superior to U heparin. Most trials evaluating heparins had methodological defects. Five trials, involving 487 patients, testing mechanical pumping devices were also methodologically flawed, and so pooled results need to be viewed cautiously. Mechanical pumping devices may protect against DVT (16/221 (7%) versus 52/229 (22%); RR 0.31; 95%CI 0.19 to 0.51) and pulmonary embolism. Data were insufficient to establish any effect on the incidence of fatal pulmonary embolism and overall mortality. Problems with skin abrasion and compliance were reported. REVIEWER'S CONCLUSIONS: U and LMW heparins protect against lower limb DVT. There is insufficient evidence to confirm either protection against pulmonary embolism or an overall benefit, or to distinguish between various applications of heparin. Foot and calf pumping devices appear to prevent DVT, may protect against pulmonary embolism, and reduce mortality, but compliance remains a problem. Good quality trials of mechanical methods as well as direct comparisons with heparin and low dose aspirin should be considered.

Interventions for preventing falls in elderly people.

BACKGROUND: Approximately 30 per cent of people over 65 years of age and living in the community fall each year; the number is higher in institutions. Although less than one fall in 10 results in a fracture, a fifth of fall incidents require medical attention. OBJECTIVES: To assess the effects of interventions designed to reduce the incidence of falls in elderly people (living in the community, or in institutional or hospital care). SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Group specialised register (January 2001), Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2001), MEDLINE (1966 to February 2001), EMBASE (1988 to 2001 Week 14), CINAHL (1982 to March 2001), The National Research Register, Issue 1, 2001, Current Controlled Trials (www.controlled-trials.com accessed 25 May 2001), and reference lists of articles. We also contacted researchers in the field. SELECTION CRITERIA: Randomised trials of interventions designed to minimise the effect of, or exposure to, risk factors for falling in elderly people. Main outcomes of interest were the number of fallers, or falls. Trials reporting only intermediate outcomes were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Data were pooled using the fixed effect model where appropriate. MAIN RESULTS: Interventions likely to be beneficial: ~bullet~A programme of muscle strengthening and balance retraining, individually prescribed at home by a trained health professional (3 trials, 566 participants, pooled relative risk (RR) 0.80, 95% confidence interval (95%CI) 0.66 to 0.98). ~bullet~A 15 week Tai Chi group exercise intervention (1 trial, 200 participants, risk ratio 0.51, 95%CI 0.36 to 0.73). ~bullet~Home hazard assessment and modification that is professionally prescribed for older people with a history of falling (1 trial, 530 participants, RR 0.64, 95% CI 0.49 to 0.84). A reduction in falls was seen both inside and outside the home. ~bullet~Withdrawal of psychotropic medication (1 trial, 93 participants, relative hazard 0.34, 95%CI 0.16 to 0.74). ~bullet~Multidisciplinary, multifactorial, health/environmental risk factor screening/intervention programmes, both for unselected community dwelling older people (data pooled from 3 trials, 1973 participants, pooled RR 0.73, 95%CI 0.63 to 0.86), and for older people with a history of falling, or selected because of known risk factors (data pooled from 2 trials, 713 participants, pooled RR 0.79, 95%CI 0.67 to 0.94). Interventions of unknown effectiveness: ~bullet~Group-delivered exercise interventions (9 trials, 2177 participants). ~bullet~Nutritional supplementation (1 trial, 50 participants). ~bullet~Vitamin D supplementation, with or without calcium (3 trials, 679 participants). ~bullet~Home hazard modification in association with advice on optimising medication (1 trial, 658 participants), or in association with an education package on exercise and reducing fall risk (1 trial, 3182 participants). ~bullet~Pharmacological therapy (raubasine-dihydroergocristine, 1 trial, 95 participants). ~bullet~Fall prevention programmes in institutional settings. ~bullet~Interventions using a cognitive/behavioural approach alone (2 trials, 145 participants). ~bullet~Home hazard modification for older people without a history of falling (1 trial, 530 participants). ~bullet~ Hormone replacement therapy (1 trial, 116 participants). Interventions unlikely to be beneficial: ~bullet~Brisk walking in women with an upper limb fracture in the previous two years (1 trial, 165 participants). REVIEWER'S CONCLUSIONS: Interventions to prevent falls that are likely to be effective are now available; less is known about their effectiveness in preventing fall-related injuries. Costs per fall prevented have been established for four of the interventions and careful economic modelling in the context of the local healthcare system is important. Some potential interventions are of unknown effectiveness and further research is indicated.

Hip protectors for preventing hip fractures in the elderly.

BACKGROUND: Hip fracture in the elderly is usually the result of a simple fall. Hip protectors have been advocated as a means to reduce the risk of sustaining a fracture in a fall on the hip. OBJECTIVES: To determine if external hip protectors reduce the incidence of hip fractures in elderly persons following a fall. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register, Cochrane Controlled Trials Register, MEDLINE, EMBASE, CINAHL and reference lists of relevant articles. Identified trialists were contacted. Date of the most recent search: December 2000. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing the use of hip protectors with a control group. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality, using a ten item scale, and extracted data. Additional information was sought from all trialists. Wherever appropriate and possible, the data are presented graphically. MAIN RESULTS: In this second update, a further trial has been included to bring the total number of included trials to seven (3553 participants). All studies involved elderly people in nursing homes or residential care or supported living at home, four within the Scandinavian countries, one in Japan, one in the United Kingdom and one in Australia. The three largest studies involving 3210 participants randomised by care unit, nursing home or nursing home ward rather than by the individual (cluster randomisation). One study of 141 individuals was primarily a compliance study lasting only 12 weeks. Summation of results from the other six studies gave an occurrence of hip fractures of 29/1313 (2.2%) for those allocated to wear hip protectors, against 130/2099 (6.2%) to those not allocated to wear protectors. However, due to the large number of participants allocated by cluster randomisation, it was not possible to determine if this difference between groups was statistically significant. No important adverse effects of the hip protectors were reported but compliance, particularly in the long term, was poor. REVIEWER'S CONCLUSIONS: Hip protectors appear to reduce the risk of hip fracture within a selected population at high risk of sustaining a hip fracture. The generalisation of the results is unknown beyond high-risk populations. Cost effectiveness is unclear. Results from ongoing trials may clarify this situation. Acceptability by users of the protectors remains a problem, due to discomfort and practicality.

Vitamin D and vitamin D analogues for preventing fractures associated with involutional and post-menopausal osteoporosis.

BACKGROUND: Due to their known effects on bone metabolism, vitamin D and related compounds have been proposed for the prevention of osteoporosis and fractures. OBJECTIVES: To determine the effects of supplementation with Vitamin D or a Vitamin D analogue in the prevention of fractures of the axial and appendicular skeleton in elderly men or women with involutional or post-menopausal osteoporosis. SEARCH STRATEGY: We searched MEDLINE, EMBASE, CINAHL, LILACS, CABNAR, BIOSIS, HEALTHSTAR, Current Contents, The Cochrane Database of Systematic Reviews, the Cochrane Musculoskeletal Injuries Group trials register, and bibliographies of identified trials and reviews. Date of the most recent search: September 2000. SELECTION CRITERIA: Any randomised or quasi-randomised trial which compared vitamin D or a vitamin D analogue, either alone or in combination with calcium supplementation, with a placebo, no intervention, or the administration of calcium supplements, with eligible fracture outcomes, in elderly men or women with involutional or post-menopausal osteoporosis. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality, by use of a nine item scale, and extracted data. Additional information was sought from trialists. Where possible the data were pooled. Pooling of data, where it was admissible, used pooled relative risk and fixed effects model. MAIN RESULTS: Almost all estimates of treatment effects are based on single studies. Administration of vitamin D3 alone without calcium co-supplementation was not associated with any reduction in incidence of hip fracture (relative risk (RR) 1.20, 95% confidence interval (CI) 0.83, 1.75) or other non-vertebral fracture. Administration of vitamin D3 with calcium co-supplementation to frail elderly people in sheltered accommodation was associated with a reduction in incidence of hip fracture (RR 0.74, 95% CI 0.60, 0.91). In healthy younger, ambulant participants the effect on hip fracture is unknown (RR 0.36, 95% CI 0.01, 8.78), although there appears to be a significant overall effect on non-vertebral fracture incidence in this group ( RR 0.46, 95% CI 0.23,0.90). Calcitriol (1,25 dihdyroxy vitamin D) was effective in reducing the incidence of vertebral deformity (RR 0.49, 95% CI 0.25, 0.95). Calcitriol was more effective than calcium in reducing the frequency of new vertebral deformities during the third year of treatment (RR 0.28, 95% CI 0.15, 0.52). 1-alpha-hydroxy vitamin D was effective in reducing the incidence of non-vertebral fractures in a single small study of elderly people whose mobility was impaired by neurological disease (RR 0.12, 95% CI 0.02, 0.95). No statistically significant effects were found for other comparisons of vitamin D or its analogues against each other, with and without calcium supplementation. REVIEWER'S CONCLUSIONS: Uncertainty remains about the efficacy of regimens which include vitamin D or its analogues in fracture prevention. Particularly if co-supplementation of calcium is required, significant cost differences are likely to exist between regimens. Further large randomised trials are currently being conducted to clarify the effectiveness of community fracture prevention programmes employing vitamin D supplementation.

Antibiotic prophylaxis for surgery for proximal femoral and other closed long bone fractures.

BACKGROUND: Wound infection and other hospital-acquired infections cause significant morbidity after internal fixation of fractures (osteosynthesis). The administration of antimicrobial agents (antibiotics) may reduce the frequency of infections. OBJECTIVES: To determine whether the prophylactic administration of antibiotics in patients undergoing surgical management of hip or other long bone fractures reduces the incidence of wound and other hospital acquired infections. SEARCH STRATEGY: We searched the The Cochrane Library, Issue 3 2000; MEDLINE, EMBASE, LILACS, Current Contents, Dissertation Abstracts, and Index to UK Theses to August 2000. Bibliographies of identified articles were screened for further relevant trials. No language restriction was applied. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials involving - Participants: Any patients with a hip or other closed long bone fracture undergoing surgery for internal fixation or replacement arthroplasty. INTERVENTIONS: Any regimen of systemic antibiotic prophylaxis administered at the time of surgery. OUTCOME MEASURES: Wound infection (deep and superficial), urinary tract infection, respiratory tract infection, adverse effects of prophylaxis, economic evaluations. DATA COLLECTION AND ANALYSIS: Two reviewers independently screened papers for inclusion, assessed trial quality using an eight item scale, and extracted data. Additional information was sought from two trialists. Pooled data are presented graphically. MAIN RESULTS: Data from 8307 participants in 22 studies were analysed. In patients undergoing surgery for closed fracture fixation, single dose antibiotic prophylaxis significantly reduced deep wound infection (relative risk 0.40, 95%CI 0.24, 0.67) superficial wound infections, urinary infections, and respiratory tract infections. Multiple dose prophylaxis had an effect of similar size on deep wound infection (relative risk 0.40, 95%CI 0.24, 0.67), but significant effects on urinary and respiratory infections were not confirmed. Economic modelling using data from one large trial indicates that single dose prophylaxis with ceftriaxone is a cost-effective intervention. There are limited data for the incidence of adverse effects, but as expected they appear to be more common in those receiving antibiotics, compared with placebo or no prophylaxis. REVIEWER'S CONCLUSIONS: Antibiotic prophylaxis should be offered to those undergoing surgery for closed fracture fixation. On ethical grounds, further placebo controlled randomised trials of the effectiveness of antibiotic prophylaxis in closed fracture surgery are unlikely to be justified. Trials addressing the cost-effectiveness of different effective antibiotic regimens would need to be very large.

Hip protectors for preventing hip fractures in the elderly.

BACKGROUND: Hip fracture in the elderly is usually the result of a simple fall. Hip protectors have been advocated as a means to reduce the risk of sustaining a fracture in a fall on the hip. OBJECTIVES: To determine if external hip protectors reduce the incidence of hip fractures in elderly persons following a fall. SEARCH STRATEGY: The Cochrane Musculoskeletal Injuries Group trials register, MEDLINE, and reference lists of relevant articles were searched, and identified trialists contacted. Date of the most recent search: July 2000. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing the use of hip protectors with a control group. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality, using a ten item scale, and extracted data. Additional information was sought from all trialists. Wherever appropriate and possible, the data are presented graphically. MAIN RESULTS: Six randomised trials involving 1752 participants were included within the review. All studies involved elderly people in nursing homes or residential care, three within the Scandinavian countries, one in Japan, one in the United Kingdom and one in Australia. The two largest studies involving 1409 participants randomised by nursing home or nursing home ward rather than by the individual (cluster randomisation). One study of 141 individuals was primarily a compliance study. Summation of results from the other five studies gave an occurrence of hip fractures of 16/660 (2.4%) for those allocated to wear hip protectors, against 63/951 (6.6%) to those not allocated to wear protectors. However due to the large number of participants allocated by cluster randomisation it was not possible to demonstrate conclusively that this difference between groups was statistically significant. Only one of the 16 hip fractures that occurred in the individuals allocated to wear hip protectors occurred whilst the protector was worn. No significant adverse effects of the hip protectors were reported but compliance, particularly in the long term, was poor. REVIEWER'S CONCLUSIONS: Hip protectors appear to reduce the risk of hip fracture within a selected population at high risk of sustaining a hip fracture. However, this conclusion is based on five trials of low to moderate quality. As two used cluster randomisation, pooling of data was limited. The generalisation of the results is unknown beyond high-risk populations. Results from eleven ongoing trials may clarify this situation. Acceptability by users of the protectors remains a problem, due to discomfort and practicality.

Are clinical and patient assessed outcomes affected by reducing length of hospital stay for total hip arthroplasty?

This prospective observational study investigated the relationship between the length of hospital stay (LOS) and outcomes at 3 months for primary total hip arthroplasty for osteoarthritis. Mean length of postoperative stay was 9.5 +/- 2.8 days. Predictors of LOS were patient's age, sex, and number of comorbidities; preoperative Charnley scores and Nottingham Health Profile measures; complications; and hospital in which surgery took place. LOS was found to have a small negative correlation with outcome. The dominant association with improved outcome was the severity of the patients' impairment preoperatively. These data suggest that in situations in which adequate rehabilitation and support are available after discharge, a marginal reduction in postoperative LOS--from the average of 10.3 days observed at 1 hospital to the average of 8 days observed at another--would not adversely affect the short-term outcome.

Vitamin D and vitamin D analogues for preventing fractures associated with involutional and post-menopausal osteoporosis.

BACKGROUND: Due to their known effects on bone metabolism, Vitamin D and related compounds have been proposed for the prevention of osteoporosis and fractures. OBJECTIVES: To determine the effects of supplementation with Vitamin D or a Vitamin D analogue in the prevention of fractures of the axial and appendicular skeleton in elderly men or women with involutional or post-menopausal osteoporosis. SEARCH STRATEGY: We searched MEDLINE, EMBASE, BIOSIS, CINAHL, HealthPLAN, Dissertation Abstracts, Index to UK Theses, Current Contents, and bibliographies of identified trials and reviews. Trials were also obtained from the Cochrane Musculoskeletal Injuries Group trials register. Date of the most recent search: December 1995. SELECTION CRITERIA: Any randomised or quasi-randomised trial which compared Vitamin D or a Vitamin D analogue, either alone or in combination with calcium supplementation, with a placebo, no intervention, or the administration of calcium supplements, with fracture as an outcome, in elderly men or women with involutional or post-menopausal osteoporosis. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality, by use of a seven item scale, and extracted data. Additional information was sought from trialists. Where possible the data were pooled. MAIN RESULTS: Fourteen trials recording 13 different comparisons were included. In the only trial of Vitamin D alone, protection against hip fracture was not confirmed. Two regimens, each represented by one large trial, which showed limited evidence of efficacy in reducing the incidence of hip or other appendicular skeleton fractures were: 1) Oral Vitamin D when accompanied by calcium supplementation. 2) 1,25 dihydroxy Vitamin D (calcitriol). This appeared more effective than calcium in a direct comparison. Regimens showing limited evidence of efficacy in reducing the incidence of vertebral deformity were: 1) 1,25 dihydroxy Vitamin D (calcitriol), which appeared more effective than calcium in one large trial, and more effective than placebo from pooled results of two small trials. 2) Oral 1-alpha hydroxy Vitamin D (alfacalcidol), when administered with calcium supplements (two small trials, which lacked power to confirm a possible effect). Hypercalcaemia and gastro-intestinal symptoms, reported in less than 5% of participants, were slightly more common when Vitamin D analogues were taken. However, the risk of death was marginally less. REVIEWER'S CONCLUSIONS: Uncertainty remains about the efficacy of regimens which include Vitamin D or its analogues in fracture prevention. Particularly if co-supplementation of calcium is required, significant cost differences are likely to exist between regimens. Further randomised trials with economic evaluation are desirable before community fracture prevention programmes employing Vitamin D supplementation can be confidently introduced.

Antibiotic prophylaxis for surgery for proximal femoral and other closed long bone fractures.

BACKGROUND: Antibiotic prophylaxis has been established policy for major surgical operations for many years. In fracture fixation, the effectiveness, and the duration of administration, have been a matter of debate. OBJECTIVES: To assess the effects of the prophylactic administration of antibiotics in patients undergoing surgical management of hip or other long bone fractures. SEARCH STRATEGY: We searched MEDLINE, EMBASE, Current Contents, Dissertation Abstracts, and Index to UK Theses, and bibliographies of identified articles. Trials were also obtained from the Cochrane Musculoskeletal Injuries Group trials register. Date of the most recent search: end of 1997. PARTICIPANTS: Any patients with a hip or other closed long bone fracture undergoing surgery for internal fixation or replacement arthroplasty. INTERVENTIONS: Any regimen of systemic antibiotic prophylaxis administered at the time of surgery. OUTCOME MEASURES: Wound infection (deep and superficial), urinary tract infection, respiratory tract infection, adverse effects of prophylaxis, economic evaluations. DATA COLLECTION AND ANALYSIS: Both reviewers independently selected trials for inclusion, and assessed methodological quality and extracted data. Where possible, data were pooled and Peto odds ratios and absolute risk reductions, each with 95% confidence intervals, calculated. MAIN RESULTS: Twenty one randomised trials of only poor or moderate quality were included. The comparisons tested fell within six comparison groups, principally multiple dose or a single dose of antibiotic versus a placebo or no treatment. Antibiotic prophylaxis reduces wound, urinary and respiratory tract infections in patients undergoing surgery for closed fracture fixation. Economic modelling has indicated that this is a cost-effective intervention. There are limited data for the incidence of adverse effects, but as expected they appear to be more common in those receiving antibiotics. REVIEWER'S CONCLUSIONS: Antibiotic prophylaxis should be offered to those undergoing surgery for closed fracture fixation. On ethical grounds, further placebo controlled randomised trials of the effectiveness of antibiotic prophylaxis in closed fracture surgery are unlikely to be justified. Trials addressing the cost-effectiveness of different effective antibiotic regimens would need to be very large and may not be feasible.

Heparin, low molecular weight heparin and physical methods for preventing deep vein thrombosis and pulmonary embolism following surgery for hip fractures.

BACKGROUND: Hip fracture patients have a high risk of thromboembolic complications following surgical management. OBJECTIVES: To examine the effects of heparin (unfractionated (U), and low molecular weight (LMW) heparins), and physical methods (compression stockings, calf or foot pumps) for prevention of deep venous thrombosis (DVT) and pulmonary embolism after surgery for hip fracture in the elderly. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group trials register, Medline, Embase, and reference lists of published papers and books. We contacted trialists and other workers in the field. Date of most recent search: September 1996. SELECTION CRITERIA: Randomised and quasi-randomised trials evaluating the use of heparins and physical agents for prevention of DVT and pulmonary embolism in patients undergoing surgery for hip fracture. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed methodological quality and extracted data. Trials were grouped into four categories (heparin versus control, mechanical versus control, LMW heparin versus U heparin, and miscellaneous) and results pooled where possible. MAIN RESULTS: The 26 included trials involved 2600 predominantly female and elderly patients. Overall, trial quality was disappointing. Ten trials involving 826 patients which compared U heparin with control, and four trials of 471 patients which compared LMW heparin with control, showed a reduction in the incidence of lower limb DVT (121/511 (24%) versus 203/519 (39%); Peto odds ratio 0.41; 95% confidence interval 0.31 to 0.55). There were insufficient data to confirm the efficacy of either agent in the prevention of pulmonary embolism. There was a non significant increase in overall mortality in the heparin group (46/420 (11%) versus 35/423 (8%); Peto odds ratio 1.39; 95% confidence interval 0. 86 to 2.23). Data were inadequate for all other outcomes including wound complications. There is insufficient evidence from five trials, involving 644 patients, to establish if LMW heparin was superior to U heparin. Most trials evaluating heparins had methodological defects. Four trials, involving 442 patients, testing mechanical pumping devices were also methodologically flawed, and so pooled results need to be viewed cautiously. Mechanical pumping devices may protect against DVT (12/202 (6%) versus 42/212 (19%); Peto odds ratio 0.24; 95% confidence interval 0.13 to 0.44). Although the limited data indicated a potential benefit, they were inadequate to establish any effect on the incidence of pulmonary embolism and overall mortality. Problems with skin abrasion and compliance were reported. REVIEWER'S CONCLUSIONS: U and LMW heparins protect against lower limb DVT. There is insufficient evidence to confirm either protection against pulmonary embolism or overall benefit, or to distinguish between various applications of heparin. Foot and calf pumping devices appear to prevent DVT, may protect against pulmonary embolism, and reduce mortality, but compliance remains a problem. Good quality trials of mechanical methods as well as direct comparisons with heparin should be considered.