Early outcomes using a 'kinematic retaining' total knee replacement - A multicentre prospective study at two years follow-up.

BACKGROUND: Although predictable implant longevity in total knee replacement (TKR) is now established, work continues to satisfy the demands of patients who seek full restoration of the painless function of the native knee following TKR. This prospective study examines the early clinical outcomes of 156 patients implanted with a novel 'kinematic-retaining' (KR) implant. METHODS: 156 Physica KR TKRs were implanted for primary osteoarthritis at three European centres. Patients were reviewed up to two years using radiographic, clinical and functional evaluations. RESULTS: Of the 137 patients retained at two years' follow up, none had been revised. Within 6 post-operative months, 51.7% and 79.9% had excellent clinical and functional KSS values respectively, increasing to 81.8% and 88.3% beyond two years. Mean KSS improvement was 34.8 (from 48.6 to 83.4). All KOOS sub-scores improved significantly with total KOOS improving from a mean of 35.5 (SD ±13.0) to 86.5 (±13.7) at two years post-operatively. Pain and sports KOOS sub-scores improved rapidly during the early post-operative periods, with sustained improvements beyond this. Mean OKS improved by 44.1 (±5.1) at two years. VAS satisfaction scores improved significantly at all time points beyond six weeks. Mean FJS-12 was 75.7 at two years, with no significant effects of age or gender. No progressive adverse radiographic features were noted. CONCLUSIONS: Early clinical and radiographic outcomes of this kinematic-retaining knee prosthesis are promising, with improvements in clinical parameters similar to, or exceeding those published in other contemporary TKR designs. LEVEL OF EVIDENCE: II, Multicentre Prospective cohort study.

Failure rates and clinical outcomes of synthetic meniscal implants following partial meniscectomy: a systematic review.

BACKGROUND: Meniscal injury is one of the most common indications for knee surgery. The advent of meniscal repair techniques has facilitated meniscal preservation in suitable cases. Meniscal substitution with scaffolds may be advantageous following partial meniscal resection. There are three main scaffolds in current clinical use; Collagen Meniscal Implant (CMI Stryker Corporation, Kalamazoo, MI, USA), Actifit (Actifit, Orteq Ltd, London, UK) and NUsurface (Active Implants, LLC). The purpose of this systematic review was to compare clinical outcomes and failure rates of patients who have had implantation with these meniscal scaffolds. METHODS: MEDLINE and EMBASE databases were searched for studies that included patients who had surgical implantation with Actifit or CMI. Eligibility criteria included papers that described both clinical outcomes and failure rates of these implants, a mean follow up of 5 years and studies published in English. A Google search was also performed to identify any grey literature. RESULTS: Five Level IV studies were found for Actifit. One Level II, one Level III and four Level IV studies were found for the CMI implant. One Level II study was identified for the NUsurface scaffold with a follow-up 12 months and was included for completeness. Overall, 262 patients were treated with Actifit, 109 with CMI and 65 with NUsurface. Failure rates for Actifit were 18% (range 6.3-31.8%) with a mean follow up of 66.8 months, and for CMI 6.5% (range 0-11.8%) with a mean follow up of 97.1 months. The NUsurface failure rate was 16.9% at 12 months. Clinical outcomes such as VAS, Tegner and Lysholm scores improved significantly post-operatively. However, there was a high volume of concurrent procedures, such as anterior cruciate ligament reconstructions and high tibial osteotomies in each study group; 118 (45%) for Actifit and 53 (45%) for CMI. CONCLUSION: The evidence for meniscal scaffold use is insufficient to suggest that they could potentially improve clinical outcomes in patients post-meniscal resection. This is largely due to the high proportion of concurrent procedures performed at index procedure for both CMI and Actifit. On the basis of current evidence, the use of meniscal scaffolds as a sole treatment for partial meniscal defects cannot be recommended, owing to the relatively high failure rate and paucity of clinical data.

The impact of change in albumin assay on reference intervals, prevalence of 'hypoalbuminaemia' and albumin prescriptions.

BACKGROUND: We studied the impact on reference intervals, classification of patients with hypoalbuminaemia and albumin infusion prescriptions on changing from a bromocresol green (BCG) to a bromocresol purple (BCP) serum albumin assay. METHODS: Passing-Bablok regression analysis and Bland-Altman plot were used to compare Abbott BCP and Roche BCG methods. Linear regression analysis was used to compare in-house and an external laboratory Abbott BCP serum albumin results. Reference intervals for Abbott BCP serum albumin were derived in two different laboratories using pathology data from adult patients in primary care. Prescriptions for 20% albumin infusions were compared one year before and one year after changing the albumin method. RESULTS: Abbott BCP assay had a negative bias of approximately 6 g/L compared with Roche BCG method.There was good agreement (y = 1.04 x - 1.03; R(2 )= 0.9933) between in-house and external laboratory Abbott BCP results. Reference intervals for the serum albumin Abbott BCP assay were 31-45 g/L, different to those recommended by Pathology Harmony and the manufacturers (35-50 g/L). Following the change in method there was a large increase in the number of patients classified as hypoalbuminaemic using Pathology Harmony references intervals (32%) but not when retrospectively compared to locally derived reference intervals (16%) compared with the previous year (12%). The method change was associated with a 44.6% increase in albumin prescriptions. This equated to an annual increase in expenditure of £35,234. CONCLUSIONS: We suggest that serum albumin reference intervals be method specific to prevent misclassification of albumin status in patients. Change in albumin methodology may have significant impact on hospital resources.

Systematic review: the safety of intra-articular corticosteroid injection prior to total knee arthroplasty.

BACKGROUND: Up to 30% of patients undergoing total knee arthroplasty (TKA) have received intra-articular corticosteroid injections prior to surgery. Debate exists as to whether such injections increase the rate of post-operative infection. Given that deep infection is a disastrous complication, a systematic review of the literature was undertaken to evaluate the safety of intra-articular corticosteroid injections given prior to TKA. Other features of corticosteroid use are also discussed including mechanism of action and optimal dosage. METHODS: Using PRISMA guidelines, EMBASE, CINAHL and MEDLINE databases were searched using the search terms 'total knee arthroplasty', 'replacement', 'corticosteroid', 'steroid', 'infection', 'safety', and relevant articles critically appraised. The Newcastle-Ottawa Scale was used to assess for bias. RESULTS: No level one or two studies were available for review. Two retrospective case control studies and two cohort studies (level three evidence) which specifically evaluated the risk of infected TKA in association with pre-operative steroid injection were reviewed: three showed that prior steroid injection was not associated with increased infection rates; one article showed that prior steroid injection was associated with a significantly increased risk of deep infection post-TKA. CONCLUSION: Clinicians commonly administer steroid injections to patients who are candidates for TKA but may be unaware of the potential long term complications. The included studies were underpowered and at risk of selection bias and only one study demonstrated an increased risk of infection post-operatively. We recommend that further research is required to evaluate the safety of steroid injection prior to TKA. LEVEL OF EVIDENCE: III.

Investigation of a problem with external quality assurance samples for faecal occult blood.

BACKGROUND: It is vital that laboratories participate in External Quality Assurance (EQA) programmes, but results from such schemes do not necessarily help ensure assays are 'in control'. We describe a series of experiments undertaken to explore apparent poor performance in an occult blood EQA scheme that manifested as a series of false-negatives. As a consequence of our laboratory misclassifying some EQA samples, we decided to design a simple sensitivity study that would reaffirm confidence in our testing procedures. METHODS: In order to verify analyst reliability and analytical sensitivity, a series of 10 faecal samples were supplemented with increasing amounts of whole blood (0-1.0 mg/Hb/g faeces) and these were then tested independently by four different operatives. EQA samples which our laboratory misclassified were shared with and tested by a second laboratory and results compared. RESULTS: The results demonstrated consistency in interpretation among the four 'testers' and also suggested that the sensitivity of the method is 0.7 rather than 0.6 mg/Hb/g faeces as claimed by the manufacturer. The second laboratory obtained identical results as our laboratory for the EQA samples which our laboratory had misclassified. CONCLUSIONS: Occult blood EQA scheme results might not give a true reflection of a laboratory's ability to provide reliable results. We would encourage any laboratory observing relative poor performance to undertake local sensitivity studies and repeat testing of EQA samples if in any doubt.

Are biochemistry interpretative comments helpful? Results of a general practitioner and nurse practitioner survey.

BACKGROUND: Adding or incorporating clinical interpretative comments on biochemistry results is widespread in UK laboratories; although this consumes considerable human resource, there is still little evidence to suggest that it is either effective or appreciated by our clinical colleagues. I therefore decided to survey our local general practitioners (GPs) and nurse practitioners to analyse whether they found biochemistry comments on reports helpful. METHODS: A simple questionnaire was designed and sent to 159 GPs and 81 nurse practitioners asking them whether they found this activity useful for the limited range of test groups that we routinely comment on and also whether they would like to see commenting on more groups of tests. RESULTS: Overall, 49.6% of questionnaires were returned. Of these, there was overwhelming support for commenting on reports and 77% would like to see comments on a greater range of tests. CONCLUSIONS: Although adding clinical interpretative comments is very time-consuming for senior laboratory staff, there is overwhelming support of this activity among our GPs and nurse practitioner users; therefore, our local policy of routinely adding clinical comments will remain for the foreseeable future.

Knee arthrodesis for limb salvage with an intramedullary coupled nail.

INTRODUCTION: The demand for revision and salvage procedures after knee arthroplasty is increasing as the number of primary procedures increases. Surgical salvage techniques when revision arthroplasty is contra-indicated include above knee amputation and arthrodesis. The results of arthrodesis are functionally superior to those of amputation but not all techniques of arthrodesis are associated with good results. MATERIALS AND METHODS: We present a single surgeon series of 14 consecutive patients who underwent arthrodesis of the knee with a customised intramedullary coupled nail (Mayday arthrodesis nail, Orthodesign Ltd, UK). All patients had a failed knee arthroplasty due to persistent sepsis. Pre-operative scaled radiographs were used to design and manufacture a custom-made implant for each patient. An identical surgical technique and post-operative rehabilitation regime were used in each case. RESULTS: The mean hospital stay was 12 days (range 6-24). Union was achieved in all but one patient at a mean of 4 months (range 3-10). One diabetic patient required subsequent above knee amputation for infected non-union. Two other patients had significant transient complications. CONCLUSION: We have found that the Mayday nail offers a straightforward, reproducible surgical option for difficult salvage surgery. Good results have been obtained in the majority of cases, avoiding the devastating consequences of above knee amputation.

Spinal injury patterns resulting from car and motorcycle accidents.

STUDY DESIGN: Retrospective data analysis. OBJECTIVES: To determine spinal injury patterns and clinical outcomes in patients involved in automotive accidents. SUMMARY OF BACKGROUND DATA: The records of 22,858 patients collected prospectively as part of the Trauma Audit Research Network (UK) Database (1993-2000). METHODS: Analysis of the records of 1121 motorcyclists and 2718 car occupants involved in automotive trauma. RESULTS: Spinal injury occurred in 126 (11.2%) motorcyclists and 383 (14.1%) car occupants. Victims were predominantly young (mean ages: motorcycle 30.2 years, car 37.8 years) and male (motorcycle 88.9%, car 60.6%). The mean Injury Severity Scores were 18.8 and 15.1, respectively. Isolated spinal injuries occurred in 30 (23.8%) motorcyclists and 130 (33.9%) car occupants. The thoracic spine was most commonly injured in motorcyclists (54.8%), and the cervical spine was most commonly injured in car occupants (50.7%). Multiple regions were injured in 14 (10.3%) motorcyclists and 33 (8.5%) car occupants. Nine motorcyclists and 43 car occupants required spinal surgery. Median hospital stays were 11.5 days (range 0-235 days) and 10 days (range 0-252 days) in the motorcyclists and car occupants, respectively. There were 13 (10.3%) motorcycle- and 26 (6.8%) car-related deaths. CONCLUSION: Spinal injury patterns may reflect differing mechanisms of injury between the restrained car occupant and unrestrained motorcyclist. The motorcyclists were more severely injured, had more extremity trauma, a higher mortality rate, and a spinal injury pattern consistent with forced hyperflexion of the thoracic spine. The predominance of cervical injuries and higher incidence of neck and facial injuries in car occupants may reflect abdominothoracic seat belt restraint. The high frequency of multilevel injuries reaffirms the need for vigilance in patient assessment.

Spinal injuries in motorcycle crashes: patterns and outcomes.

BACKGROUND: The purpose of this study was to determine patterns of spinal injury and clinical outcomes resulting from motorcycle crashes. METHODS: We analyzed data collected on 1,121 motorcyclists involved in road traffic accidents (from 1993-2000) and identified those who had sustained a spinal injury. RESULTS: Spinal injury occurred in 126 (11.2%) riders (112 male riders [88.9%] and 14 female riders [11.1%]), with a mean age of 30.2 years (range, 16-61 years) and Injury Severity Score of 18.8 (range, 4-66). Isolated injuries to the spine occurred in 30 (23.8%) riders. The thoracic spine was injured in 69 (54.8%), the lumbar spine in 37 (29.4%), and the cervical spine in 34 (27.0%) cases. Multiple vertebral levels were affected in 54 (42.9%). Neurologic injury occurred in 25 riders (19.8%), with complete distal neurologic injury in 14 (4 cervical, 9 thoracic, and 1 lumbar). Eleven (8.7%) patients required spinal surgery. There were 13 (10.3%) deaths. CONCLUSION: The thoracic spine is the most commonly injured spinal region in motorcycle crashes. Multiple level injuries are common. Protocols concentrating on the radiographic clearance of the cervical region may miss a significant number of spinal injuries. Vigilance is required in assessing these patients, who often have multiple injuries.