Watchful Waiting Versus Surgery of Mildly Symptomatic or Asymptomatic Inguinal Hernia in Men Aged 50 Years and Older: A Randomized Controlled Trial.

OBJECTIVE: To compare if watchful waiting is noninferior to elective repair in men aged 50 years and older with mildly symptomatic or asymptomatic inguinal hernia. BACKGROUND: The role of watchful waiting in older male patients with mildly symptomatic or asymptomatic inguinal hernia is still not well-established. METHODS: In this noninferiority trial, we randomly assigned men aged 50 years and older with mildly symptomatic or asymptomatic inguinal hernia to either elective inguinal hernia repair or watchful waiting. Primary endpoint was the mean difference in a 4-point pain/discomfort score at 24 months of follow-up. Using a 0.20-point difference as a clinically relevant margin, it was hypothesized that watchful waiting was noninferior to elective repair. Secondary endpoints included quality of life, event-free survival, and crossover rates. RESULTS: Between January 2006 and August 2012, 528 patients were enrolled, of whom 496 met the inclusion criteria: 234 were assigned to elective repair and 262 to watchful waiting. The mean pain/discomfort score at 24 months was 0.35 [95% confidence interval (CI) 0.28-0.41)] in the elective repair group and 0.58 (95% CI 0.52-0.64) in the watchful waiting group. The difference of these means (MD) was -0.23 (95% CI -0.32 to -0.14). In the watchful waiting group, 93 patients (35·4%) eventually underwent elective surgery and 6 patients (2·3%) received emergent surgery for strangulation/incarceration. Postoperative complication rates and recurrence rates in these 99 operated individuals were comparable with individuals originally assigned to the elective repair group (8.1% vs 15.0%; P = 0.106, 7.1% vs 8.9%; P = 0.668, respectively). CONCLUSIONS: Our data could not rule out a relevant difference in favor of elective repair with regard to the primary endpoint. Nevertheless, in view of all other findings, we feel that our results justify watchful waiting as a reasonable alternative compared with surgery in men aged 50 years and older.

Early mobilisation versus plaster immobilisation of simple elbow dislocations: results of the FuncSiE multicentre randomised clinical trial.

BACKGROUND/AIM: To compare outcome of early mobilisation and plaster immobilisation in patients with a simple elbow dislocation. We hypothesised that early mobilisation would result in earlier functional recovery. METHODS: From August 2009 to September 2012, 100 adult patients with a simple elbow dislocation were enrolled in this multicentre randomised controlled trial. Patients were randomised to early mobilisation (n=48) or 3 weeks plaster immobilisation (n=52). Primary outcome measure was the Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score. Secondary outcomes were the Oxford Elbow Score, Mayo Elbow Performance Index, pain, range of motion, complications and activity resumption. Patients were followed for 1 year. RESULTS: Quick-DASH scores at 1 year were 4.0 (95% CI 0.9 to 7.1) points in the early mobilisation group versus 4.2 (95% CI 1.2 to 7.2) in the plaster immobilisation group. At 6 weeks, early mobilised patients reported less disability (Quick-DASH 12 (95% CI 9 to 15) points vs 19 (95% CI 16 to 22); p<0.05) and had a larger arc of flexion and extension (121° (95% CI 115° to 127°) vs 102° (95% CI 96° to 108°); p<0.05). Patients returned to work sooner after early mobilisation (10 vs 18 days; p=0.020). Complications occurred in 12 patients; this was unrelated to treatment. No recurrent dislocations occurred. CONCLUSIONS: Early active mobilisation is a safe and effective treatment for simple elbow dislocations. Patients recovered faster and returned to work earlier without increasing the complication rate. No evidence was found supporting treatment benefit at 1 year. TRIAL REGISTRATION NUMBER: NTR 2025.

Inter- and intra-observer agreement of the AO classification for operatively treated distal radius fractures.

The reproducibility of the AO classification for distal radius fractures remains a topic of debate. Previous studies showed variable reproducibility results. Important treatment decisions depend on correct classification, especially in comminuted, intra-articular fractures. Therefore, reliable reproducibility results need to be undisputedly determined. Hence, the study objective was to assess inter- and intra-observer agreement of the AO classification for operatively treated distal radius fractures. A database of 54 radiographs of all AO types (A, B and C) and groups (A2-3, B1-3, and C1-3) of distal radius fractures was assessed in twofold. Likewise, a subset of 152 radiographs of solely C-type groups (C1-3) was assessed. All fractures were classified by six observers with different experience levels: three consultant trauma surgeons, one sixth-year trauma surgery resident, a consultant trauma radiologist, and an intern with limited experienced. The inter-observer agreement of both main types and groups was moderate (κ = 0.49 resp. κ = 0.48) in combination with a good intra-observer agreement (κ = 0.68 resp. κ = 0.70). The inter-observer agreement of the subset C-type fractures group was fair (κ = 0.27) with moderate intra-observer agreement (κ = 0.43). According to these results, the reproducibility of the AO classification of main types and groups of distal radius fractures based on conventional radiographs is insufficient (κ < 0.50), especially at group level of C-type fractures.

Good functional recovery of complex elbow dislocations treated with hinged external fixation: a multicenter prospective study.

BACKGROUND: After a complex dislocation, some elbows remain unstable after closed reduction or fracture treatment. Function after treatment with a hinged external fixator theoretically allows collateral ligaments to heal without surgical reconstruction. However, there is a lack of prospective studies that assess functional outcome, pain, and ROM. QUESTIONS/PURPOSES: We asked: (1) In complex elbow fracture-dislocations, does treatment with a hinged external fixator result in reduction of disability and pain, and in improvement in ROM, function, and quality of life? (2) Does delayed treatment (7 days or later) have a negative effect on ROM after 1 year? (3) What are the complications seen after external fixator treatment? METHODS: During a 2-year period, 11 centers recruited 27 patients 18 years or older who were included and evaluated at 2 and 6 weeks and at 3, 6, and 12 months after surgery as part of this prospective case series. During the study period, the participating centers agreed on general indications for use of the hinged external fixator, which included persistent instability after closed reduction alone or closed reduction combined with surgical treatment of associated fracture(s), when indicated. Functional outcome was evaluated using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH; primary outcome) score, the Mayo Elbow Performance Index (MEPI), the Oxford Elbow Score, and the level of pain (VAS). ROM, adverse events, secondary interventions, and radiographs also were evaluated. A total of 26 of the 27 patients (96%) were available for followup at 1 year. RESULTS: All functional and pain scores improved. The median QuickDASH score decreased from 30 (25(th)-75(th) percentiles [P25-P75], 23-40) at 6 weeks to 7 (P25-P75, 2-12) at 1 year with a median difference of -25 (p < 0.001). The median MEPI score increased from 80 (P25-P75, 64-85) at 6 weeks to 100 (P25-P75, 85-100) at 1 year with a median difference of 15 (p < 0.001). The median Oxford Elbow Score increased from 60 (P25-P75, 44-68) at 6 weeks to 90 (P25-P75, 73-96) at 1 year with a median difference of 29 (p < 0.001). The median VAS decreased from 2.8 (P25-P75, 1.0-5.0) at 2 weeks to 0.5 (P25-P75, 0.0-1.9) at 1 year with a median difference of -2.1 (p = 0.001). ROM also improved. The median flexion-extension arc improved from 50° (P25-P75, 33°-80°) at 2 weeks to 118° (P25-P75, 105°-138°) at 1 year with a median difference of 63° (p < 0.001). Similarly, the median pronation-supination arc improved from 90° (P25-P75, 63°-124°) to 160° (P25-P75, 138°-170°) with a median difference of 75° (p < 0.001). At 1 year, the median residual deficit compared with the uninjured side was 30° (P25-P75, 5°-35°) for the flexion-extension arc, and 3° (P25-P75, 0°-25°) for the pronation-supination arc. Ten patients (37%) experienced a fixator-related complication, and seven patients required secondary surgery (26%). One patient reported recurrent instability. CONCLUSIONS: A hinged external elbow fixator provides enough stability to start early mobilization after an acute complex elbow dislocation and residual instability. This was reflected in good functional outcome scores and only slight disability despite a relatively high complication rate.

HUMeral shaft fractures: measuring recovery after operative versus non-operative treatment (HUMMER): a multicenter comparative observational study.

BACKGROUND: Fractures of the humeral shaft are associated with a profound temporary (and in the elderly sometimes even permanent) impairment of independence and quality of life. These fractures can be treated operatively or non-operatively, but the optimal tailored treatment is an unresolved problem. As no high-quality comparative randomized or observational studies are available, a recent Cochrane review concluded there is no evidence of sufficient scientific quality available to inform the decision to operate or not. Since randomized controlled trials for this injury have shown feasibility issues, this study is designed to provide the best achievable evidence to answer this unresolved problem. The primary aim of this study is to evaluate functional recovery after operative versus non-operative treatment in adult patients who sustained a humeral shaft fracture. Secondary aims include the effect of treatment on pain, complications, generic health-related quality of life, time to resumption of activities of daily living and work, and cost-effectiveness. The main hypothesis is that operative treatment will result in faster recovery. METHODS/DESIGN: The design of the study will be a multicenter prospective observational study of 400 patients who have sustained a humeral shaft fracture, AO type 12A or 12B. Treatment decision (i.e., operative or non-operative) will be left to the discretion of the treating surgeon. Critical elements of treatment will be registered and outcome will be monitored at regular intervals over the subsequent 12 months. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand score. Secondary outcome measures are the Constant score, pain level at both sides, range of motion of the elbow and shoulder joint at both sides, radiographic healing, rate of complications and (secondary) interventions, health-related quality of life (Short-Form 36 and EuroQol-5D), time to resumption of ADL/work, and cost-effectiveness. Data will be analyzed using univariate and multivariable analyses (including mixed effects regression analysis). The cost-effectiveness analysis will be performed from a societal perspective. DISCUSSION: Successful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register (NTR3617).

The reliability, validity and responsiveness of the Dutch version of the Oxford elbow score.

BACKGROUND: The Oxford elbow score (OES) is an English questionnaire that measures the patients' subjective experience of elbow surgery. The OES comprises three domains: elbow function, pain, and social-psychological effects. This questionnaire can be completed by the patient and used as an outcome measure after elbow surgery. The aim of this study was to develop and evaluate the Dutch version of the translated OES for reliability, validity and responsiveness with respect to patients after elbow trauma and surgery. METHODS: The 12 items of the English-language OES were translated into Dutch and then back-translated; the back-translated questionnaire was then compared to the original English version. The OES Dutch version was completed by 69 patients (group A), 60 of whom had an elbow luxation, four an elbow fracture and five an epicondylitis. QuickDASH, the visual analogue pain scale (VAS) and the Mayo Elbow Performance Index (MEPI) were also completed to examine the convergent validity of the OES in group A. To calculate the test-retest reliability and responsiveness of the OES, this questionnaire was completed three times by 43 different patients (group B). An average of 52 days elapsed between therapy and the administration of the third OES (SD = 24.1). RESULTS: The Cronbach's α coefficients for the function, pain and social-psychological domains were 0.90, 0.87 and 0.90, respectively. The intra-class correlation coefficients for the domains were 0.87 for function, 0.89 for pain and 0.87 for social-psychological. The standardised response means for the domains were 0.69, 0.46 and 0.60, respectively, and the minimal detectable changes were 27.6, 21.7 and 24.0, respectively. The convergent validity for the function, pain and social-psychological domains, which were measured as the Spearman's correlation of the OES domains with the MEPI, were 0.68, 0.77 and 0.77, respectively. The Spearman's correlations of the OES domains with QuickDASH were -0.43, -0.44 and -0.47, respectively, and the Spearman's correlations with the VAS were -0.33, -0.38 and -0.42, respectively. CONCLUSIONS: The Dutch OES is a reliable and valid 12-item questionnaire that can be completed within several minutes by patients with elbow injuries. This Dutch questionnaire was useful as an outcome measure in patients with elbow trauma.

A hinged external fixator for complex elbow dislocations: a multicenter prospective cohort study.

BACKGROUND: Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures of the radial head, olecranon, or coronoid process. The majority of patients with these complex dislocations are treated with open reduction and internal fixation (ORIF), or arthroplasty in case of a non-reconstructable radial head fracture. If the elbow joint remains unstable after fracture fixation, a hinged elbow fixator can be applied. The fixator provides stability to the elbow joint, and allows for early mobilization. The latter may be important for preventing stiffness of the joint. The aim of this study is to determine the effect of early mobilization with a hinged external elbow fixator on clinical outcome in patients with complex elbow dislocations with residual instability following fracture fixation. METHODS/DESIGN: The design of the study will be a multicenter prospective cohort study of 30 patients who have sustained a complex elbow dislocation and are treated with a hinged elbow fixator following fracture fixation because of residual instability. Early active motion exercises within the limits of pain will be started immediately after surgery under supervision of a physical therapist. Outcome will be evaluated at regular intervals over the subsequent 12 months. The primary outcome is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford Elbow Score, pain level at both sides, range of motion of the elbow joint at both sides, radiographic healing of the fractures and formation of periarticular ossifications, rate of secondary interventions and complications, and health-related quality of life (Short-Form 36). DISCUSSION: The outcome of this study will yield quantitative data on the functional outcome in patients with a complex elbow dislocation and who are treated with ORIF and additional stabilization with a hinged elbow fixator. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register (NTR1996).

Rasch analysis of the Dutch version of the Oxford elbow score.

BACKGROUND: The Oxford elbow score (OES) is a patient-rated, 12-item questionnaire that measures quality of life in relation to elbow disorders. This English questionnaire has been proven to be a reliable and valid instrument. Recently, the OES has been translated into Dutch and examined for its reliability, validity, and responsiveness in a group of Dutch patients with elbow pathology. The aim of this study was to analyze the Dutch version of the OES (OES-DV) in combination with Rasch analysis or the one-parameter item response theory to examine the structure of the questionnaire. METHODS: The OES-DV was administered to 103 patients (68 female, 35 male). The mean age of the patients was 44.3 ± 14.7 (range 15-75) years. Rasch analysis was performed using the Winsteps(®) Rasch Measurement Version 3.70.1.1 and a rating scale parameterization. RESULTS: The person separation index, which is a measure of person reliability, was excellent (2.30). All the items of the OES had a reasonable mean square infit or outfit value between 0.6 and 1.7. The threshold of items were ordered, so the categories can function as intended. Principal component analysis of the residuals partly confirmed the multidimensionality of the English version of the OES. The OES distinguished 3.4 strata, which indicates that about three ranges can be differentiated. CONCLUSION: Rasch analysis of the OES-DV showed that the data fit to the stringent Rasch model. The multidimensionality of the English version of the OES was partly confirmed, and the four items of the function and three items of the pain domain were recognized as separate domains. The category rating scale of the OES-DV works well. The OES can distinguish 3.4 strata. This conclusion can only be applied to elbow dislocations, which were the largest group of patients studied.

Functional treatment versus plaster for simple elbow dislocations (FuncSiE): a randomized trial.

BACKGROUND: Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures. After reduction of a simple dislocation, treatment options include immobilization in a static plaster for different periods of time or so-called functional treatment. Functional treatment is characterized by early active motion within the limits of pain with or without the use of a sling or hinged brace. Theoretically, functional treatment should prevent stiffness without introducing increased joint instability. The primary aim of this randomized controlled trial is to compare early functional treatment versus plaster immobilization following simple dislocations of the elbow. METHODS/DESIGN: The design of the study will be a multicenter randomized controlled trial of 100 patients who have sustained a simple elbow dislocation. After reduction of the dislocation, patients are randomized between a pressure bandage for 5-7 days and early functional treatment or a plaster in 90 degrees flexion, neutral position for pro-supination for a period of three weeks. In the functional group, treatment is started with early active motion within the limits of pain. Function, pain, and radiographic recovery will be evaluated at regular intervals over the subsequent 12 months. The primary outcome measure is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford elbow score, pain level at both sides, range of motion of the elbow joint at both sides, rate of secondary interventions and complication rates in both groups (secondary dislocation, instability, relaxation), health-related quality of life (Short-Form 36 and EuroQol-5D), radiographic appearance of the elbow joint (degenerative changes and heterotopic ossifications), costs, and cost-effectiveness. DISCUSSION: The successful completion of this trial will provide evidence on the effectiveness of a functional treatment for the management of simple elbow dislocations. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register (NTR2025).

Complex and unstable simple elbow dislocations: a review and quantitative analysis of individual patient data.

OBJECTIVE: The primary objective of this review of the literature with quantitative analysis of individual patient data was to identify the results of available treatments for complex elbow dislocations and unstable simple elbow dislocations. The secondary objective was to compare the results of patients with complex elbow dislocations and unstable elbow joints after repositioning of simple elbow dislocations, which were treated with an external fixator versus without an external fixator. SEARCH STRATEGY: Electronic databases MEDLINE, EMBASE, LILACS, and the Cochrane Central Register of Controlled Trials. SELECTION CRITERIA: Studies were eligible for inclusion if they included individual patient data of patients with complex elbow dislocations and unstable simple elbow dislocations. DATA ANALYSIS: The different outcome measures (MEPI, Broberg and Morrey, ASES, DASH, ROM, arthritis grading) are presented with mean and confidence intervals. MAIN RESULTS: The outcome measures show an acceptable range of motion with good functional scores of the different questionnaires and a low mean arthritis score. Thus, treatment of complex elbow dislocations with ORIF led to a moderate to good result. Treatment of unstable simple elbow dislocations with repair of the collateral ligaments with or without the combination of an external fixator is also a good option. The physician-rated (MEPI, Broberg and Morrey), patient-rated (DASH) and physician- and patient-rated (ASES) questionnaires showed good intercorrelations. Arthritis classification by x-ray is only fairly correlated with range of motion. Elbow dislocations are mainly on the non-dominant side.

Dislocation of the elbow: a retrospective multicentre study of 86 patients.

The objective of this retrospective multicentre cohort study was to prospectively assess the long-term functional outcomes of simple and complex elbow dislocations.We analysed the hospital and outpatient records of 86 patients between 01.03.1999 and 25.02.2009 with an elbow dislocation. After a mean follow-up of 3.3 years, all patients were re-examined at the outpatient clinic for measurement of different outcomes.The mean range of motion was ROM 135.5 degrees . The Mayo elbow performance index (MEPI) scored an average of 91.9 (87.5% of the patients were rated excellent or good). The average Quick disabilities of the arm, shoulder and hand (Quick- DASH) score was 9.7, the sports/music score 11.5 and work score 6.1. The Oxford function score was 75.7, Oxford pain score 75.2 and Oxford social-psychological score 73.9.Elbow dislocation is a mild disease and generally, the outcome is excellent. Functional results might improve with early active movements.

Primary shoulder arthroplasty versus conservative treatment for comminuted proximal humeral fractures: a systematic literature review.

The objective was to identify whether arthroplasty or conservative treatment is the best available treatment for three- and four-part proximal humeral fractures by analyzing the outcome measure of the Constant score. We conducted an electronic search. The systematic review included 33 studies encompassing 1096 patients with three- or four-part proximal humeral fractures that used the Constant score as outcome measure. The mean Constant score in the conservative group was 66.5 and in the arthroplasty group was 55.5. The difference could be attributed to selection bias, unreliable classification of the fractures and inter-observer differences in the assessment of the Constant score.