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Bone & Joint Research
Vol. 5, Issue 1 | Pages 18 - 25
1 Jan 2016
Sims AL Parsons N Achten J Griffin XL Costa ML Reed MR

Background. Approximately half of all hip fractures are displaced intracapsular fractures. The standard treatment for these fractures is either hemiarthroplasty or total hip arthroplasty. The recent National Institute for Health and Care Excellence (NICE) guidance on hip fracture management recommends the use of ‘proven’ cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of at least 3B (97% survival at three years). The Thompsons prosthesis is currently lacking an ODEP rating despite over 50 years of clinical use, likely due to the paucity of implant survival data. Nationally, adherence to these guidelines is varied as there is debate as to which prosthesis optimises patient outcomes. Design. This study design is a multi-centre, multi-surgeon, parallel, two arm, standard-of-care pragmatic randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700). The main analysis is a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head. Secondary outcomes will include radiological leg length discrepancy measured as per Bidwai and Willett, mortality, re-operation rate and indication for re-operation, length of index hospital stay and revision at four months. This study will be supplemented by the NHFD (National Hip Fracture Database) dataset. Discussion. Evidence on the optimum choice of prosthesis for hemiarthroplasty of the hip is lacking. National guidance is currently based on expert opinion rather than empirical evidence. The incidence of hip fracture is likely to continue to increase and providing high quality evidence on the optimum treatment will improve patient outcomes and have important health economic implications. Cite this article: A. L. Sims. The World Hip Trauma Evaluation Study 3: Hemiarthroplasty Evaluation by Multicentre Investigation – WH. I. TE 3: HEMI – An Abridged Protocol. Bone Joint Res 2016;5:18–25. doi: 10.1302/2046-3758.51.2000473


Bone & Joint Research
Vol. 5, Issue 10 | Pages 481 - 489
1 Oct 2016
Handoll HHG Brealey SD Jefferson L Keding A Brooksbank AJ Johnstone AJ Candal-Couto JJ Rangan A

Objectives. Accurate characterisation of fractures is essential in fracture management trials. However, this is often hampered by poor inter-observer agreement. This article describes the practicalities of defining the fracture population, based on the Neer classification, within a pragmatic multicentre randomised controlled trial in which surgical treatment was compared with non-surgical treatment in adults with displaced fractures of the proximal humerus involving the surgical neck. Methods. The trial manual illustrated the Neer classification of proximal humeral fractures. However, in addition to surgical neck displacement, surgeons assessing patient eligibility reported on whether either or both of the tuberosities were involved. Anonymised electronic versions of baseline radiographs were sought for all 250 trial participants. A protocol, data collection tool and training presentation were developed and tested in a pilot study. These were then used in a formal assessment and classification of the trial fractures by two independent senior orthopaedic shoulder trauma surgeons. Results. Two or more baseline radiographic views were obtained for each participant. The independent raters confirmed that all fractures would have been considered for surgery in contemporaneous practice. A full description of the fracture population based on the Neer classification was obtained. The agreement between the categorisation at baseline (tuberosity involvement) and Neer classification as assessed by the two raters was only fair (kappa 0.29). However, this disparity did not appear to affect trial findings, specifically in terms of influencing the effect of treatment on the primary outcome of the trial. Conclusions. A key reporting requirement, namely the description of the fracture population, was achieved within the context of a pragmatic multicentre randomised clinical trial. This article provides important guidance for researchers designing similar trials on fracture management. Cite this article: H. H. G. Handoll, S. D. Brealey, L. Jefferson, A. Keding, A. J. Brooksbank, A. J. Johnstone, J. J. Candal-Couto, A. Rangan. Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.Bone Joint Res 2016;5:481–489. DOI: 10.1302/2046-3758.510.BJR-2016-0132.R1


The Bone & Joint Journal
Vol. 99-B, Issue 7 | Pages 964 - 972
1 Jul 2017
Duckworth AD Clement ND McEachan JE White TO Court-Brown CM McQueen MM

Aims. The aim of this prospective randomised controlled trial was to compare non-operative and operative management for acute isolated displaced fractures of the olecranon in patients aged ≥ 75 years. Patients and Methods. Patients were randomised to either non-operative management or operative management with either tension-band wiring or fixation with a plate. They were reviewed at six weeks, three and six months and one year after the injury. The primary outcome measure was the Disabilities of the Arm, Shoulder and Hand (DASH) score at one year. Results. A total of 19 patients were randomised to non-operative (n = 8) or operative (n = 11; tension-band wiring (n = 9), plate (n = 2)) management. The trial was stopped prematurely as the rate of complications (nine out of 11, 81.8%) in the operative group was considered to be unacceptable. There was, however, no difference in the mean DASH scores between the groups at all times. The mean score was 23 (0 to 59.6) in the non-operative group and 22 (2.5 to 57.8) in the operative group, one year after the injury (p = 0.763). There was no significant difference between groups in the secondary outcome measures of the Broberg and Morrey Score or the Mayo Elbow Score at any time during the one year following injury (all p ≥ 0.05). . Conclusion. These data further support the role of primary non-operative management of isolated displaced fractures of the olecranon in the elderly. However, the non-inferiority of non-operative management cannot be proved as the trial was stopped prematurely. Cite this article: Bone Joint J 2017;99-B:964–72


Bone & Joint Research
Vol. 3, Issue 12 | Pages 335 - 340
1 Dec 2014
Handoll HHG Goodchild L Brealey SD Hanchard NCA Jefferson L Keding A Rangan A

Objectives . A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults. Methods . These processes included the development of a patient information leaflet on self-care during sling immobilisation, the development of a basic treatment physiotherapy protocol that received input and endorsement by specialist physiotherapists providing patient care, and establishing an expectation for the provision of home exercises. Specially designed forms were also developed to facilitate reliable reporting of the physiotherapy care that patients received. Results. All three initiatives were successfully implemented, alongside the measures to optimise the documentation of physiotherapy. Thus, all participating sites that recruited patients provided the sling immobilisation leaflet, all adhered to the physiotherapy protocol and all provided home exercises. There was exemplary completion of the physiotherapy forms that often reflected a complex patient care pathway. These data demonstrated equal and high access to and implementation of physiotherapy between groups, including the performance of home exercises. Conclusion . In order to increase the validity and relevance of the evidence from trials of surgical interventions and meet international reporting standards, careful attention to study design, conduct and reporting of the intrinsic rehabilitation components is required. The involvement of rehabilitation specialists is crucial to achieving this. Cite this article: Bone Joint Res 2014;3:335–40


The Bone & Joint Journal
Vol. 97-B, Issue 6 | Pages 786 - 792
1 Jun 2015
Hutt JRB Farhadnia P Massé V Lavigne M Vendittoli P

This randomised trial evaluated the outcome of a single design of unicompartmental arthroplasty of the knee (UKA) with either a cemented all-polyethylene or a metal-backed modular tibial component. A total of 63 knees in 45 patients (17 male, 28 female) were included, 27 in the all-polyethylene group and 36 in the metal-backed group. The mean age was 57.9 years (39.6 to 76.9). At a mean follow-up of 6.4 years (5 to 9.9), 11 all-polyethylene components (41%) were revised (at a mean of 5.8 years; 1.4 to 8.0) post-operatively and two metal-backed components were revised (at one and five years). One revision in both groups was for unexplained pain, one in the metal-backed group was for progression of osteoarthritis. The others in the all-polyethylene group were for aseptic loosening. The survivorship at seven years calculated by the Kaplan–Meier method for the all-polyethylene group was 56.5% (95% CI 31.9 to 75.2, number at risk 7) and for the metal-backed group was 93.8% (95% CI 77.3 to 98.4, number at risk 16) This difference was statistically significant (p <  0.001). At the most recent follow-up, significantly better mean Western Ontario and McMaster Universities Arthritis Index Scores were found in the all-polyethylene group (13.4 vs 23.0, p = 0.03) but there was no difference in the mean Knee injury and Osteoarthritis Outcome scores (68.8; 41.4 to 99.0 vs 62.6; 24.0 to 100.0), p = 0.36). There were no significant differences for range of movement (p = 0.36) or satisfaction (p = 0.23). This randomised study demonstrates that all-polyethylene components in this design of fixed bearing UKA had unsatisfactory results with significantly higher rates of failure before ten years compared with the metal-back components. Cite this article: Bone Joint J 2015;97-B:786–92


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 10 | Pages 1397 - 1401
1 Oct 2005
Walmsley PJ Kelly MB Hill RMF Brenkel I

The routine use of surgical drains in total hip arthroplasty remains controversial. They have not been shown to decrease the rate of wound infection significantly and can provide a retrograde route for it. Their use does not reduce the size or incidence of post-operative wound haematomas. This prospective, randomised study was designed to evaluate the role of drains in routine total hip arthroplasty. We investigated 552 patients (577 hips) undergoing unilateral or bilateral total hip arthroplasty who had been randomised to either having a drain for 24 hours or not having a drain. All patients followed standardised pre-, intra-, and post-operative regimes and were independently assessed using the Harris hip score before operation and at six, 18 and 36 months follow-up. The rate of superficial and deep infection was 2.9% and 0.4%, respectively, in the drained group and 4.8% and 0.7%, respectively in the undrained group. One patient in the undrained group had a haematoma which did not require drainage or transfusion. The rate of transfusion after operation in the drained group was significantly higher than for undrained procedures (p < 0.042). The use of a drain did not influence the post-operative levels of haemoglobin, the revision rates, Harris hip scores, the length of hospital stay or the incidence of thromboembolism. We conclude that drains provide no clear advantage at total hip arthroplasty, represent an additional cost, and expose patients to a higher risk of transfusion


The Bone & Joint Journal
Vol. 97-B, Issue 12 | Pages 1608 - 1614
1 Dec 2015
Tice A Kim P Dinh† L Ryu JJ Beaulé PE

The primary purpose of this study of metal-on-metal (MoM) hip resurfacing was to compare the effect of using a cementless or cemented femoral component on the subsequent bone mineral density (BMD) of the femoral neck. . This was a single-centre, prospective, double-blinded control trial which randomised 120 patients (105 men and 15 women) with a mean age of 49.4 years (21 to 68) to receive either a cemented or cementless femoral component. Follow-up was to two years. Outcome measures included total and six-point region-of-interest BMD of the femoral neck, radiological measurements of acetabular inclination, neck-shaft and stem-shaft angles, and functional outcome scores including the Harris hip score, the Western Ontario and McMaster Universities Osteoarthritis Index and the University of California at Los Angeles activity scale. In total, 17 patients were lost to follow-up leaving 103 patients at two years. There were no revisions in the cementless group and three revisions (5%) in the cemented group (two because of hip pain and one for pseudotumour). The total BMD was significantly higher in the cementless group at six months (p < 0.001) and one year (p = 0.01) than in the cemented group, although there was a loss of statistical significance in the difference at two years (p = 0.155). . All patient outcomes improved significantly: there were no significant differences between the two groups. . The results show better preservation of femoral neck BMD with a cementless femoral component after two years of follow-up. Further investigation is needed to establish whether this translates into improved survivorship. Cite this article: Bone Joint J 2015;97-B:1608–14


Bone & Joint Research
Vol. 5, Issue 5 | Pages 185 - 190
1 May 2016
Yuenyongviwat V Iamthanaporn K Hongnaparak T Tangtrakulwanich B

Objectives. Nylon sutures and skin staples are used commonly in total knee arthroplasty (TKA) surgical wound closure. However, there is no study that compares the wound healing efficacy and patient satisfaction scores of both techniques in the same knee. Methods. We randomised 70 patients who underwent primary TKA into two groups. In one group of 34 patients, the skin at the upper half of the wound was closed with skin staples and the lower half of the wound was closed with simple interrupted nylon sutures. In the other group of 36 patients, the skin at the upper half of the wound was closed with nylon stitches and the lower half of the wound was closed with skin staples. We recorded the wound closure time, pain score at the time of stitch removal, wound complication rate, patient satisfaction score, and the Hollander wound evaluation score at the post-operative periods of five days, 14 days, six weeks, three months, and six months. Each half wound was analysed separately. Results. The mean patient body mass index was 26.8 kg/m. 2. (standard deviation 6.3). A total of 70 nylon stitched wounds and 70 skin stapled wounds were analysed. There were no significant differences in wound complication rates, patient satisfaction score, and the Hollander wound evaluation score between both types of wounds (p > 0.05). The wound closure time for skin stapled wounds was significantly lower than the nylon stitched wounds (p < 0.001). However, the skin stapled wounds had a significantly higher pain score at the time of stitch removal (p < 0.001). Conclusion. Skin staples and nylon stitches had comparable results with respect to wound healing and patient satisfaction in TKA wound closure in non-obese patients. The benefit of skin staples over nylon stitches was a decrease in operative time, but was more painful upon removal. Cite this article: V. Yuenyongviwat. A randomised controlled trial comparing skin closure in total knee arthroplasty in the same knee: nylon sutures versus skin staples. Bone Joint Res 2016;5:185–190. DOI: 10.1302/2046-3758.55.2000629


The Bone & Joint Journal
Vol. 98-B, Issue 10 | Pages 1399 - 1405
1 Oct 2016
Rohilla R Wadhwani J Devgan A Singh R Khanna M

Aims. This is a prospective randomised study which compares the radiological and functional outcomes of ring and rail fixators in patients with an infected gap (> 3 cm) nonunion of the tibia. Patients and Methods. Between May 2008 and February 2013, 70 patients were treated at our Institute for a posttraumatic osseocutaneous defect of the tibia measuring at least 3 cm. These were randomised into two groups of 35 patients using the lottery method. Group I patients were treated with a ring fixator and group II patients with a rail fixator. The mean age was 33.2 years (18 to 64) in group I and 29.3 years (18 to 65) in group II. The mean bone gap was 5.84 cm in group I and 5.78 cm in group II. The mean followup was 33.8 months in group I and 32.6 months in group II. Bone and functional results were assessed using the classification of the Association for the Study and Application of the Method of Ilizarov (ASAMI). Functional results were also assessed at six months using the short musculoskeletal functional assessment (SMFA) score. Results. The bone result was excellent, good, fair and poor in 21, 12, 0 and 2 in group I; and 14, 15, 3, and 3 in group II, respectively. The functional results were excellent, good, fair, poor and failure in 16, 17, 1, 0 and 1 in group I; and 22, 10, 0, 3 and 0 in group II, respectively. Both fixator systems achieved comparable rates of union and functional outcomes. The rate of deep pintract infection was significantly higher in the rail fixator group but patients found it more comfortable. Conclusion. We recommend the use of a ring fixator in patients with a bone gap of more than 6 cm. Patients with a bone gap up to 6 cm can be managed with either a ring or rail fixator. Cite this article: Bone Joint J 2016;98B:1399–1405


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 4 | Pages 451 - 454
1 Apr 2008
Amin A Watson A Mangwani J Nawabi DH Ahluwalia R Loeffler M

We undertook a prospective randomised controlled trial to investigate the efficacy of autologous retransfusion drains in reducing the need for allogenic blood requirement after unilateral total knee replacement. We also monitored the incidence of post-operative complications. There were 86 patients in the control group, receiving standard care with a vacuum drain, and 92 who received an autologous drain and were retransfused postoperatively. Following serial haemoglobin measurements at 24, 48 and 72 hours, we found no difference in the need for allogenic blood between the two groups (control group 15.1%, retransfusion group 13% (p = 0.439)). The incidence of post-operative complications, such as wound infection, deep-vein thrombosis and chest infection, was also comparable between the groups. There were no adverse reactions associated with the retransfusion of autologous blood. Based on this study, the cost-effectiveness and continued use of autologous drains in total knee replacement should be questioned


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 4 | Pages 459 - 465
1 Apr 2012
Nikolaou VS Edwards MR Bogoch E Schemitsch EH Waddell JP

The ideal bearing surface for young patients undergoing total hip replacement (THR) remains controversial. We report the five-year results of a randomised controlled trial comparing the clinical and radiological outcomes of 102 THRs in 91 patients who were <  65 years of age. These patients were randomised to receive a cobalt–chrome on ultra-high-molecular-weight polyethylene, cobalt–chrome on highly cross-linked polyethylene, or a ceramic-on-ceramic bearing. In all, 97 hip replacements in 87 patients were available for review at five years. Two hips had been revised, one for infection and one for peri-prosthetic fracture. At the final follow-up there were no significant differences between the groups for the mean Western Ontario and McMaster Universities osteoarthritis index (pain, p = 0.543; function, p = 0.10; stiffness, p = 0.99), Short Form-12 (physical component, p = 0.878; mental component, p = 0.818) or Harris hip scores (p = 0.22). Radiological outcomes revealed no significant wear in the ceramic group. Comparison of standard and highly cross-linked polyethylene, however, revealed an almost threefold difference in the mean annual linear wear rates (0.151 mm/year versus 0.059 mm/year, respectively) (p < 0.001)


The Bone & Joint Journal
Vol. 96-B, Issue 7 | Pages 907 - 913
1 Jul 2014
Dossett HG Estrada NA Swartz GJ LeFevre GW Kwasman BG

We have previously reported the short-term radiological results of a randomised controlled trial comparing kinematically aligned total knee replacement (TKR) and mechanically aligned TKR, along with early pain and function scores. In this study we report the two-year clinical results from this trial. A total of 88 patients (88 knees) were randomly allocated to undergo either kinematically aligned TKR using patient-specific guides, or mechanically aligned TKR using conventional instruments. They were analysed on an intention-to-treat basis. The patients and the clinical evaluator were blinded to the method of alignment. At a minimum of two years, all outcomes were better for the kinematically aligned group, as determined by the mean Oxford knee score (40 (15 to 48) versus 33 (13 to 48); p = 0.005), the mean Western Ontario McMaster Universities Arthritis index (WOMAC) (15 (0 to 63) versus 26 (0 to 73); p = 0.005), mean combined Knee Society score (160 (93 to 200) versus 137 (64 to 200); p= 0.005) and mean flexion of 121° (100 to 150) versus 113° (80 to 130) (p = 0.002). The odds ratio of having a pain-free knee at two years with the kinematically aligned technique (Oxford and WOMAC pain scores) was 3.2 (p = 0.020) and 4.9 (p = 0.001), respectively, compared with the mechanically aligned technique. Patients in the kinematically aligned group walked a mean of 50 feet further in hospital prior to discharge compared with the mechanically aligned group (p = 0.044). In this study, the use of a kinematic alignment technique performed with patient-specific guides provided better pain relief and restored better function and range of movement than the mechanical alignment technique performed with conventional instruments. Cite this article: Bone Joint J 2014;96-B:907–13


The Bone & Joint Journal
Vol. 97-B, Issue 7 | Pages 973 - 981
1 Jul 2015
Fong DYT Cheung KMC Wong YW Cheung WY Fu ICY Kuong EE Mak KC To M Samartzis D Luk KDK

Randomised controlled trials (RCTs) that assessed the efficacy of bracing for adolescent idiopathic scoliosis have suffered from small sample sizes, low compliance and lack of willingness to participate. The aim of this study was to assess the feasibility of a comprehensive cohort study for evaluating both the efficacy and the effectiveness of bracing in patients with adolescent idiopathic scoliosis. Patients with curves at greater risk of progression were invited to join a randomised controlled trial. Those who declined were given the option to remain in the study and to choose whether they wished to be braced or observed. Of 87 eligible patients (5 boys and 63 girls) identified over one year, 68 (78%) with mean age of 12.5 years (10 to 15) consented to participate, with a mean follow-up of 168 weeks (0 to 290). Of these, 19 (28%) accepted randomisation. Of those who declined randomisation, 18 (37%) chose a brace. Patients who were more satisfied with their image were more likely to choose bracing (Odds Ratio 4.1; 95% confidence interval 1.1 to 15.0; p = 0.035). This comprehensive cohort study design facilitates the assessment of both efficacy and effectiveness of bracing in patients with adolescent idiopathic scoliosis, which is not feasible in a conventional randomised controlled trial. Cite this article: Bone Joint J 2015; 97-B:973–81


The Bone & Joint Journal
Vol. 97-B, Issue 11 | Pages 1458 - 1462
1 Nov 2015
Langlois J Atlan F Scemama C Courpied JP Hamadouche M

Most published randomised controlled trials which compare the rates of wear of conventional and cross-linked (XL) polyethylene (PE) in total hip arthroplasty (THA) have described their use with a cementless acetabular component. . We conducted a prospective randomised study to assess the rates of penetration of two distinct types of PE in otherwise identical cemented all-PE acetabular components. . A total of 100 consecutive patients for THA were randomised to receive an acetabular component which had been either highly XL then remelted or moderately XL then annealed. . After a minimum of eight years follow-up, 38 hips in the XL group and 30 hips in the annealed group had complete data (mean follow-up of 9.1 years (7.6 to 10.7) and 8.7 years (7.2 to 10.2), respectively). In the XL group, the steady state rate of penetration from one year onwards was -0.0002 mm/year (. sd. 0.108): in the annealed group it was 0.1382 mm/year (. sd. 0.129) (Mann–Whitney U test, p < 0.001). No complication specific to either material was recorded. These results show that the yearly linear rate of femoral head penetration can be significantly reduced by using a highly XLPE cemented acetabular component. Cite this article: Bone Joint J 2015;97-B:1458–62


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 1 | Pages 69 - 74
1 Jan 2009
Wood PLR Sutton C Mishra V Suneja R

We describe the results of a randomised, prospective study of 200 ankle replacements carried out between March 2000 and July 2003 at a single centre to compare the Buechel-Pappas (BP) and the Scandinavian Total Ankle Replacement (STAR) implant with a minimum follow-up of 36 months. The two prostheses were similar in design consisting of three components with a meniscal polyethylene bearing which was highly congruent on its planar tibial surface and on its curved talar surface. However, the designs were markedly different with respect to the geometry of the articular surface of the talus and its overall shape. A total of 16 ankles (18%) was revised, of which 12 were from the BP group and four of the STAR group. The six-year survivorship of the BP design was 79% (95% confidence interval (CI) 63.4 to 88.5 and of the STAR 95% (95% CI 87.2 to 98.1). The difference did not reach statistical significance (p = 0.09). However, varus or valgus deformity before surgery did have a significant effect) (p = 0.02) on survivorship in both groups, with the likelihood of revision being directly proportional to the size of the angular deformity. Our findings support previous studies which suggested that total ankle replacement should be undertaken with extreme caution in the presence of marked varus or valgus deformity


The Bone & Joint Journal
Vol. 97-B, Issue 7 | Pages 924 - 932
1 Jul 2015
Lee MC Ha C Elmallah RK Cherian JJ Cho JJ Kim TW Bin S Mont MA

The aim of this study was to assess the effect of injecting genetically engineered chondrocytes expressing transforming growth factor beta 1 (TGF-β1) into the knees of patients with osteoarthritis. We assessed the resultant function, pain and quality of life. . A total of 54 patients (20 men, 34 women) who had a mean age of 58 years (50 to 66) were blinded and randomised (1:1) to receive a single injection of the active treatment or a placebo. We assessed post-treatment function, pain severity, physical function, quality of life and the incidence of treatment-associated adverse events. Patients were followed at four, 12 and 24 weeks after injection. At final follow-up the treatment group had a significantly greater improvement in the mean International Knee Documentation Committee score than the placebo group (16 points; -18 to 49, vs 8 points; -4 to 37, respectively; p = 0.03). The treatment group also had a significantly improved mean visual analogue score at final follow-up (-25; -85 to 34, vs -11 points; -51 to 25, respectively; p = 0.032). Both cohorts showed an improvement in Western Ontario and McMaster Osteoarthritis Index and Knee Injury and Osteoarthritis Outcome Scores, but these differences were not statistically significant. One patient had an anaphylactic reaction to the preservation medium, but recovered within 24 hours. All other adverse events were localised and resolved without further action. . This technique may result in improved clinical outcomes, with the aim of slowing the degenerative process, leading to improvements in pain and function. However, imaging and direct observational studies are needed to verify cartilage regeneration. Nevertheless, this study provided a sufficient basis to proceed to further clinical testing. Cite this article: Bone Joint J 2015;97-B:924–32


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 8 | Pages 997 - 1002
1 Aug 2006
Vendittoli P Lavigne M Girard J Roy AG

We have undertaken a prospective, randomised study to compare conservation of acetabular bone after total hip replacement and resurfacing arthroplasty of the hip. We randomly assigned 210 hips to one of the two treatment groups. Uncemented, press-fit acetabular components were used for both. No significant difference was found in the mean diameter of acetabular implant inserted in the groups (54.74 mm for total hip replacement and 54.90 mm for resurfacing arthroplasty). In seven resurfacing procedures (6.8%), the surgeon used a larger size of component in order to match the corresponding diameter of the femoral component. With resurfacing arthroplasty, conservation of bone is clearly advantageous on the femoral side. Our study has shown that, with a specific design of acetabular implant and by following a careful surgical technique, removal of bone on the acetabular side is comparable with that of total hip replacement


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 11 | Pages 1462 - 1467
1 Nov 2012
Schouten R Malone AA Tiffen C Frampton CM Hooper G

In a double-blinded randomised controlled trial, 83 patients with primary osteoarthritis of the hip received either a ceramic-on-metal (CoM) or metal-on-metal (MoM) total hip replacement (THR). The implants differed only in the bearing surfaces used. The serum levels of cobalt and chromium and functional outcome scores were compared pre-operatively and at six and 12 months post-operatively. Data were available for 41 CoM and 36 MoM THRs (four patients were lost to follow-up, two received incorrect implants). The baseline characteristics of both cohorts were similar. Femoral head size measured 36 mm in all but two patients who had 28 mm heads. The mean serum cobalt and chromium levels increased in both groups, with no difference noted between groups at six months (cobalt p = 0.67, chromium p = 0.87) and 12 months (cobalt p = 0.76, chromium p = 0.76) post-operatively. Similarly, the mean Oxford hip scores, Western Ontario and McMaster Universities Osteoarthritis index and University of California, Los Angeles activity scores showed comparable improvement at 12 months. Our findings indicate that CoM and MoM couplings are associated with an equivalent increase in serum cobalt and chromium levels, and comparable functional outcome scores at six and 12-months follow-up.


The Journal of Bone & Joint Surgery British Volume
Vol. 83-B, Issue 3 | Pages 397 - 402
1 Apr 2001
Freedman KB Back S Bernstein J

We reviewed all 717 manuscripts published in the 1997 issues of the British and American volumes of the Journal of Bone and Joint Surgery and in Clinical Orthopaedics and Related Research, from which 33 randomised, controlled trials were identified. The results and sample sizes were used to calculate the statistical power of the study to distinguish small (0.2 of standard deviation), medium (0.5 of standard deviation), and large (0.8 of standard deviation) effect sizes. Of the 33 manuscripts analysed, only three studies (9%) described calculations of sample size. To perform post-hoc power assessments and estimations of deficiencies of sample size, the standard effect sizes of Cohen (small, medium and large) were calculated. Of the 25 studies which reported negative results, none had adequate power (β < 0.2) to detect a small effect size and 12 (48%) lacked the power necessary to detect a large effect size. Of the 25 studies which did not have an adequate size of sample to detect small differences, the average used was only 10% of the required number. Our findings suggest that randomised, controlled trials in clinical orthopaedic research utilise sample sizes which are too small to ensure statistical significance for what may be clinically important results


The Bone & Joint Journal
Vol. 96-B, Issue 4 | Pages 473 - 478
1 Apr 2014
van Jonbergen HPW Scholtes VAB Poolman RW

In the absence of patellar resurfacing, we have previously shown that the use of electrocautery around the margin of the patella improved the one-year clinical outcome of total knee replacement (TKR). In this prospective randomised study we compared the mean 3.7 year (1.1 to 4.2) clinical outcomes of 300 TKRs performed with and without electrocautery of the patellar rim: this is an update of a previous report. The overall prevalence of anterior knee pain was 32% (95% confidence intervals [CI] 26 to 39), and 26% (95% CI 18 to 35) in the intervention group compared with 38% (95% CI 29 to 48) in the control group (chi-squared test; p = 0.06). The overall prevalence of anterior knee pain remained unchanged between the one-year and 3.7 year follow-up (chi-squared test; p = 0.12). The mean total Western Ontario McMasters Universities Osteoarthritis Indices and the American Knee Society knee and function scores at 3.7 years’ follow-up were similar in the intervention and control groups (repeated measures analysis of variance p = 0.43, p = 0.09 and p = 0.59, respectively). There were no complications. A total of ten patients (intervention group three, control group seven) required secondary patellar resurfacing after the first year. Our study suggests that the improved clinical outcome with electrocautery denervation compared with no electrocautery is not maintained at a mean of 3.7 years’ follow-up. Cite this article: Bone Joint J 2014;96-B:473–8


The Bone & Joint Journal
Vol. 95-B, Issue 3 | Pages 354 - 359
1 Mar 2013
Chareancholvanich K Narkbunnam R Pornrattanamaneewong C

Patient-specific cutting guides (PSCGs) are designed to improve the accuracy of alignment of total knee replacement (TKR). We compared the accuracy of limb alignment and component positioning after TKR performed using PSCGs or conventional instrumentation. A total of 80 patients were randomised to undergo TKR with either of the different forms of instrumentation, and radiological outcomes and peri-operative factors such as operating time were assessed. No significant difference was observed between the groups in terms of tibiofemoral angle or femoral component alignment. Although the tibial component in the PSCGs group was measurably closer to neutral alignment than in the conventional group, the size of the difference was very small (89.8° (. sd. 1.2) vs 90.5° (. sd. 1.6); p = 0.030). This new technology slightly shortened the bone-cutting time by a mean of 3.6 minutes (p < 0.001) and the operating time by a mean 5.1 minutes (p = 0.019), without tangible differences in post-operative blood loss (p = 0.528) or need for blood transfusion (p = 0.789). This study demonstrated that both PSCGs and conventional instrumentation restore limb alignment and place the components with the similar accuracy. The minimal advantages of PSCGs in terms of consistency of alignment or operative time are unlikely to be clinically relevant. Cite this article: Bone Joint J 2013;95-B:354–9


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 9 | Pages 1210 - 1217
1 Sep 2007
Peyser A Weil YA Brocke L Sela Y Mosheiff R Mattan Y Manor O Liebergall M

Limited access surgery is thought to reduce post-operative morbidity and provide faster recovery of function. The percutaneous compression plate (PCCP) is a recently introduced device for the fixation of intertrochanteric fractures with minimal exposure. It has several potential mechanical advantages over the conventional compression hip screw (CHS). Our aim in this prospective, randomised, controlled study was to compare the outcome of patients operated on using these two devices. We randomised 104 patients with intertrochanteric fractures (AO/OTA 31.A1–A2) to surgical treatment with either the PCCP or CHS and followed them for one year postoperatively. The mean operating blood loss was 161.0 ml (8 to 450) in the PCCP group and 374.0 ml (11 to 980) in the CHS group (Student’s t-test, p < 0.0001). The pain score and ability to bear weight were significantly better in the PCCP group at six weeks post-operatively. Analysis of the radiographs in a proportion of the patients revealed a reduced amount of medial displacement in the PCCP group (two patients, 4%) compared with the CHS group (10 patients, 18.9%); Fisher’s exact test, p < 0.02. The PCCP device was associated with reduced intra-operative blood loss, less postoperative pain and a reduced incidence of collapse of the fracture


The Bone & Joint Journal
Vol. 97-B, Issue 5 | Pages 595 - 602
1 May 2015
McCalden RW Korczak A Somerville L Yuan X Naudie DD

This was a randomised controlled trial studying the safety of a new short metaphyseal fixation (SMF) stem. We hypothesised that it would have similar early clinical results and micromovement to those of a standard-length tapered Synergy metaphyseal fixation stem. Using radiostereometric analysis (RSA) we compared the two stems in 43 patients. A short metaphyseal fixation stem was used in 22 patients and a Synergy stem in 21 patients. No difference was found in the clinical outcomes pre- or post-operatively between groups. RSA showed no significant differences two years post-operatively in mean micromovement between the two stems (except for varus/valgus tilt at p = 0.05) (subsidence 0.94 mm (. sd.  1.71) vs 0.32 mm (. sd. 0.45), p = 0.66; rotation 0.96° (. sd. 1.49) vs 1.41° (. sd. 2.95), p = 0.88; and total migration 1.09 mm (. sd. 1.74) vs 0.73 mm (. sd. 0.72), p = 0.51). A few stems (four SMF and three Synergy) had initial migration > 1.0 mm but stabilised by three to six months, with the exception of one SMF stem which required revision three years post-operatively. For most stems, total micromovement was very low at two years (subsidence < 0.5 mm, rotation < 1.0°, total migration < 0.5 mm), which was consistent with osseous ingrowth. The small sample makes it difficult to confirm the universal applicability of or elucidate the potential contraindications to the use of this particular new design of stem. Cite this article: Bone Joint J 2015; 97-B:595–602


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 8 | Pages 1054 - 1059
1 Aug 2011
van Jonbergen HPW Scholtes VAB van Kampen A Poolman RW

The efficacy of circumpatellar electrocautery in reducing the incidence of post-operative anterior knee pain is unknown. We conducted a single-centre, outcome-assessor and patient-blinded, parallel-group, randomised, controlled trial to compare circumpatellar electrocautery with no electrocautery in total knee replacement in the absence of patellar resurfacing. Patients requiring knee replacement for primary osteoarthritis were randomly assigned circumpatellar electrocautery (intervention group) or no electrocautery (control group). The primary outcome measure was the incidence of anterior knee pain. A secondary measure was the standardised clinical and patient-reported outcomes determined by the American Knee Society scores and the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index. A total of 131 knees received circumpatellar electrocautery and 131 had no electrocautery. The overall incidence of anterior knee pain at follow-up at one year was 26% (20% to 31%), with 19% (12% to 26%) in the intervention group and 32% (24% to 40%) in the control group (p = 0.02). The relative risk reduction from electrocautery was 40% (9% to 61%) and the number needed to treat was 7.7 (4.3 to 41.4). The intervention group had a better mean total WOMAC score at follow-up at one year compared with the control group (16.3 (0 to 77.7) versus 21.6 (0 to 76.7), p = 0.04). The mean post-operative American Knee Society knee scores and function scores were similar in the intervention and control groups (knee score: 92.4 (55 to 100) versus 90.4 (51 to 100), respectively (p = 0.14); function score: 86.5 (15 to 100) versus 84.5 (30 to 100), respectively (p = 0.49)). Our study suggests that in the absence of patellar resurfacing electrocautery around the margin of the patella improves the outcome of total knee replacement


The Journal of Bone & Joint Surgery British Volume
Vol. 85-B, Issue 2 | Pages 223 - 230
1 Mar 2003
Bentley G Biant LC Carrington RWJ Akmal M Goldberg A Williams AM Skinner JA Pringle J

Autologous chondrocyte implantation (ACI) and mosaicplasty are both claimed to be successful for the repair of defects of the articular cartilage of the knee but there has been no comparative study of the two methods. A total of 100 patients with a mean age of 31.3 years (16 to 49) and with a symptomatic lesion of the articular cartilage in the knee which was suitable for cartilage repair was randomised to undergo either ACI or mosaicplasty; 58 patients had ACI and 42 mosaicplasty. Most lesions were post-traumatic and the mean size of the defect was 4.66 cm. 2. The mean duration of symptoms was 7.2 years and the mean number of previous operations, excluding arthroscopy, was 1.5. The mean follow-up was 19 months (12 to 26). Functional assessment using the modified Cincinatti and Stanmore scores and objective clinical assessment showed that 88% had excellent or good results after ACI compared with 69% after mosaicplasty. Arthroscopy at one year demonstrated excellent or good repairs in 82% after ACI and in 34% after mosaicplasty. All five patellar mosaicplasties failed. Our prospective, randomised, clinical trial has shown significant superiority of ACI over mosaicplasty for the repair of articular defects in the knee. The results for ACI are comparable with those in other studies, but those for mosaicplasty suggest that its continued use is of dubious value


The Journal of Bone & Joint Surgery British Volume
Vol. 71-B, Issue 4 | Pages 681 - 684
1 Aug 1989
Lilius G Laasonen E Myllynen P Harilainen A Gronlund G

A group of 109 patients with unilateral low back pain for over three months were randomised to receive one of three types of injection treatment: cortisone and local anaesthetic injected into two facet joints (28), the same mixture around two facet joints (39), or physiological saline into two facet joints (42). The effect of the treatment was evaluated in relation to work attendance, pain, disability and movements of the lumbar spine. Patients were examined one hour and two and six weeks after treatment and also completed a questionnaire after three months. A significant improvement was observed in work attendance, pain and disability scores, but this was independent of the treatment given and movements of the lumbar spine were not improved. Of the 70 patients with initial pain relief after injection, 36% reported persisting benefit at the three month follow-up, independent of the mode of treatment given. We conclude that facet joint injection is a non-specific method of treatment and the good results depend on a tendency to spontaneous regression and to the psychosocial aspects of back pain


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 12 | Pages 1608 - 1614
1 Dec 2007
Baker PN Khaw FM Kirk LMG Esler CNA Gregg PJ

We report the long-term survival of a prospective randomised consecutive series of 501 primary knee replacements using the press-fit condylar posterior cruciate ligament-retaining prosthesis. Patients received either cemented (219 patients, 277 implants) or cementless (177 patients, 224 implants) fixation. Altogether, 44 of 501 knees (8.8%) underwent revision surgery (24 cemented vs 20 cementless). For cemented knees the 15-year survival rate was 80.7% (95% confidence interval (CI) 71.5 to 87.4) and for cementless knees it was 75.3% (95% CI 63.5 to 84.3). There was no significant difference between the two groups (cemented vs cementless; hazard ratio (HR) 0.83, 95% CI 0.45 to 1.52, p = 0.55). When comparing the covariates there was no significant difference in the rates of survival between the side of operation (HR 0.58, p = 0.07), age (HR 0.97, p = 0.10) and diagnosis (HR 1.25 p = 0.72). However, there was a significant gender difference, with males having a higher failure rate with cemented fixation (HR 2.48, p = 0.004). Females had a similar failure rate in both groups. This single-surgeon series, with no loss to follow-up, provides reliable data of the revision rates of one of the most commonly-used total knee replacements. The survival of the press-fit condylar total knee replacement remained good at 15 years, irrespective of the method of fixation


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 5 | Pages 704 - 708
1 May 2012
Mauffrey C McGuinness K Parsons N Achten J Costa ML

The ideal form of fixation for displaced, extra-articular fractures of the distal tibia remains controversial. In the UK, open reduction and internal fixation with locking-plates and intramedullary nailing are the two most common forms of treatment. Both techniques provide reliable fixation but both are associated with specific complications. There is little information regarding the functional recovery following either procedure. We performed a randomised pilot trial to determine the functional outcome of 24 adult patients treated with either a locking-plate (n = 12) or an intramedullary nailing (n = 12). At six months, there was an adjusted difference of 13 points in the Disability Rating Index in favour of the intramedullary nail. However, this was not statistically significant in this pilot trial (p = 0.498). A total of seven patients required further surgery in the locking-plate group and one in the intramedullary nail group. This study suggests that there may be clinically relevant, functional differences in patients treated with nail versus locking-plate fixation for fractures of the distal tibia and differences in related complications. Further trials are required to confirm the findings of this pilot investigation


The Bone & Joint Journal
Vol. 98-B, Issue 9 | Pages 1248 - 1252
1 Sep 2016
White TO Bugler KE Appleton P Will† E McQueen MM Court-Brown CM

Aims. The fundamental concept of open reduction and internal fixation (ORIF) of ankle fractures has not changed appreciably since the 1960s and, whilst widely used, is associated with complications including wound dehiscence and infection, prominent hardware and failure. Closed reduction and intramedullary fixation (CRIF) using a fibular nail, wires or screws is biomechanically stronger, requires minimal incisions, and has low-profile hardware. We hypothesised that fibular nailing in the elderly would have similar functional outcomes to standard fixation, with a reduced rate of wound and hardware problems. Patients and Methods. A total of 100 patients (25 men, 75 women) over the age of 65 years with unstable ankle fractures were randomised to undergo standard ORIF or fibular nailing (11 men and 39 women in the ORIF group, 14 men and 36 women in the fibular nail group). The mean age was 74 years (65 to 93) and all patients had at least one medical comorbidity. Complications, patient related outcome measures and cost-effectiveness were assessed over 12 months. Results. Significantly fewer wound infections occurred in the fibular nail group (p = 0.002). At one year, there was no evidence of difference in mean functional scores (Olerud and Molander Scores 63; 30 to 85, versus 61; 10 to 35, p = 0.61) or scar satisfaction. The overall cost of treatment in the fibular nail group was £91 less than in the ORIF group despite the higher initial cost of the implant. Conclusion. We conclude that the fibular nail allows accurate reduction and secure fixation of ankle fractures, with a significantly lower rate of soft-tissue complications, and is more cost-effective than ORIF. Cite this article: Bone Joint J 2016;98-B:1248–52


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 1 | Pages 77 - 82
1 Jan 2010
Karthikeyan S Kwong HT Upadhyay PK Parsons N Drew SJ Griffin D

We have carried out a prospective double-blind randomised controlled trial to compare the efficacy of a single subacromial injection of the non-steroidal anti-inflammatory drug, tenoxicam, with a single injection of methylprednisolone in patients with subacromial impingement. A total of 58 patients were randomly allocated into two groups. Group A received 40 mg of methylprednisolone and group B 20 mg of tenoxicam as a subacromial injection along with lignocaine. The Constant-Murley shoulder score was used as the primary outcome measure and the Disability of Arm, Shoulder and Hand (DASH) and the Oxford Shoulder Score (OSS) as secondary measures. Six weeks after injection the improvement in the Constant-Murley score was significantly greater in the methylprednisolone group (p = 0.003) than in the tenoxicam group. The improvement in the DASH score was greater in the steroid group and the difference was statistically significant and consistent two (p < 0.01), four (p < 0.01) and six weeks (p < 0.020) after the injection. The improvement in the OSS was consistently greater in the steroid group than in the tenoxicam group. Although the difference was statistically significant at two (p < 0.001) and four (p = 0.003) weeks after the injection, it was not at six weeks (p = 0.055). Subacromial injection of tenoxicam does not offer an equivalent outcome to subacromial injection of corticosteroid at six weeks. Corticosteroid is significantly better than tenoxicam for improving shoulder function in tendonitis of the rotator cuff after six weeks


The Journal of Bone & Joint Surgery British Volume
Vol. 75-B, Issue 5 | Pages 825 - 829
1 Sep 1993
Klosok J Pring D Jessop J Maffulli N

We compared the chevron and the Wilson metatarsal osteotomy for hallux valgus in a prospective randomised trial on 87 feet in 51 patients, reviewed at averages of 5.5 and 38 months after operation. The patients in the chevron group returned to work earlier and mobilised faster, but, at the later review, those in the Wilson group had better functional results and were more satisfied with the appearance of the foot. Correction of the hallux valgus angle was better maintained in patients in the Wilson group and they had a better range of motion at the metatarsophalangeal joint; fewer complained of metatarsalgia


The Journal of Bone & Joint Surgery British Volume
Vol. 73-B, Issue 6 | Pages 965 - 968
1 Nov 1991
Hope P Williamson D Coates C Cole W

A prospective randomised clinical trial was undertaken to compare biodegradable polyglycolic acid pins with standard Kirschner wires used to fix displaced elbow fractures in children. Twenty-four children were enrolled in the trial; 14 had fractures of the lateral condyle of the humerus, eight of the medial epicondyle and two had olecranon fractures. Eleven fractures were fixed with Kirschner wires and 13 with polyglycolic acid pins. Fracture union with full function occurred in all cases within six months. Kirschner wires caused problems including infection in three cases, soft-tissue ossification in one and they required removal under general anaesthesia in nine cases. No such complications occurred with polyglycolic acid pins but one patient in this group developed avascular necrosis and premature fusion of the medial epicondyle


Bone & Joint Research
Vol. 6, Issue 10 | Pages 600 - 601
1 Oct 2017
Ghert M


The Journal of Bone & Joint Surgery British Volume
Vol. 75-B, Issue 5 | Pages 789 - 793
1 Sep 1993
Radford P Needoff M Webb J

We made a randomised prospective comparison of the Dynamic Hip Screw and the Gamma locking nail for the internal fixation of 200 petrochanteric femoral fractures in elderly patients. There was less intraoperative blood loss and a lower rate of wound complications in the patients treated by the Gamma nail. They had, however, a high incidence of femoral shaft fracture which we relate in part to implant design. We do not recommend the use of the Gamma nail for these fractures


The Journal of Bone & Joint Surgery British Volume
Vol. 75-B, Issue 5 | Pages 794 - 796
1 Sep 1993
Anderson G Harper W Connolly C Badham J Goodrich N Gregg P

We report the results of a randomised trial to determine the effects of skin traction on 252 patients awaiting surgery for fractures of the proximal femur. They were allocated randomly to be nursed free in bed or to receive Hamilton-Russell skin traction. No differences were found between the groups in terms of pain suffered, analgesia required, frequency of pressure sores or ease of operation. The application of skin traction to patients with fractures of the upper femur is time-consuming and we recommend therefore that its routine use should be discontinued


The Journal of Bone & Joint Surgery British Volume
Vol. 72-B, Issue 3 | Pages 507 - 509
1 May 1990
van der Ham A Hackeng C Yo T

We treated 249 patients for ingrowing toenails in a prospective randomised study which compared wedge excision with segmental phenol cauterisation. Follow-up of 97% was at a minimum of 14 months. The analgesic requirement was significantly lower after phenol cauterisation (p less than 0.001), and significantly fewer patients needed to miss school or work (p = 0.001). Recurrence of ingrowth was seen in 16% after wedge excision and 9.6% after phenol cauterisation (not significant), but re-operation was significantly less frequent after phenol (p less than 0.01). Phenol cauterisation gives better short-term and long-term results than wedge resection


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 8 | Pages 1033 - 1044
1 Aug 2011
Periasamy K Watson WS Mohammed A Murray H Walker B Patil S Meek RMD

The ideal acetabular component is characterised by reliable, long-term fixation with physiological loading of bone and a low rate of wear. Trabecular metal is a porous construct of tantalum which promotes bony ingrowth, has a modulus of elasticity similar to that of cancellous bone, and should be an excellent material for fixation. Between 2004 and 2006, 55 patients were randomised to receive either a cemented polyethylene or a monobloc trabecular metal acetabular component with a polyethylene articular surface. We measured the peri-prosthetic bone density around the acetabular components for up to two years using dual-energy x-ray absorptiometry. We found evidence that the cemented acetabular component loaded the acetabular bone centromedially whereas the trabecular metal monobloc loaded the lateral rim and behaved like a hemispherical rigid metal component with regard to loading of the acetabular bone. We suspect that this was due to the peripheral titanium rim used for the mechanism of insertion


The Journal of Bone & Joint Surgery British Volume
Vol. 76-B, Issue 1 | Pages 82 - 87
1 Jan 1994
Jonsson H Elmqvist L Karrholm J Tegner Y

We report a review of 54 patients with chronic anterior cruciate ligament rupture treated by patellar-quadriceps tendon graft augmented with polypropylene braid (Kennedy-LAD). The femoral placement of the graft was randomised to either a modified over-the-top (OTT) or a tunnel position obtained by an isometric drill guide (ISO). At the two-year follow-up both procedures had resulted in improvement of subjective knee function and activity level. Stereoradiographic measurements showed reduction of anteroposterior laxity to near normal in about one-third of the patients, but muscle strength and objective functional performance showed little or no changes. The OTT group had better subjective knee function. We were unable to confirm the theoretical advantages of the use of the drill guide, partly because it provided a tibial tunnel which was too anterior


The Journal of Bone & Joint Surgery British Volume
Vol. 76-B, Issue 4 | Pages 654 - 659
1 Jul 1994
Beard D Dodd C Trundle H Simpson A

We performed a prospective, double-blind, randomised, clinical trial to investigate the efficacy of two regimes of rehabilitation for knees with anterior cruciate ligament deficiency (ACLD). Fifty ACLD patients were randomly allocated to one of two treatment groups: a programme of muscle strengthening (T) or a programme designed to enhance proprioception and improve hamstring contraction reflexes (P). An indirect measure of proprioception, the reflex hamstring contraction latency (RHCL), and a functional scoring system were used to record the status of the knee before and after the 12-week course of physiotherapy. Sagittal knee laxity was also measured. There was improvement in mean RHCL and in the mean functional score in both groups after treatment. The improvement in group P was significantly greater than that in group T. There was no significant change in joint laxity after treatment in either group. In both groups there was a positive correlation between improvement in RHCL and functional gain


The Journal of Bone & Joint Surgery British Volume
Vol. 84-B, Issue 5 | Pages 658 - 666
1 Jul 2002
Khaw FM Kirk LMG Morris RW Gregg PJ

We have carried out a long-term survival analysis of a prospective, randomised trail comparing cemented with cementless fixation of press-fit condylar primary total knee replacements. A consecutive series of 501 replacements received either cemented (219 patients, 277 implants) or cementless (177 patients, 224 implants) fixation. The patients were contacted at a mean follow-up of 7.4 years (2.7 to 13.0) to establish the rate of survival of the implant. The ten-year survival was compared using life-table and Cox’s proportional hazard analysis. No patient was lost to follow-up. The survival at ten years was 95.3% (95% CI 90.3 to 97.8) and 95.6% (95% CI 89.5 to 98.2) in the cemented and cementless groups, respectively. The hazard ratio for failure in cemented compared with cementless prostheses was 0.97 (95% CI 0.36 to 2.6). A comparison of the clinical outcome at ten years in 80 knees showed no difference between the two groups. The survival of the press-fit condylar total knee replacement at ten years is good irrespective of the method of fixation and brings into question the use of more expensive cementless implants


The Journal of Bone & Joint Surgery British Volume
Vol. 77-B, Issue 6 | Pages 870 - 874
1 Nov 1995
Koo K Kim R Ko G Song H Jeong S Cho S

We performed a randomised trial on 37 hips (33 patients) with early-stage osteonecrosis (ON). After the initial clinical evaluation, including plain radiography and MRI, 18 hips were randomly assigned to a core-decompression group and 19 to a conservatively-treated group. All the patients were regularly followed up by clinical evaluation, plain radiography and MRI at intervals of three months. Hip pain was relieved in nine out of ten initially symptomatic hips in the core-decompression group but persisted in three out of four initially painful hips in the conservatively-treated group at the second assessment (p < 0.05). At a minimum follow-up of 24 months, 14 of the 18 core-decompressed hips (78%) and 15 of the 19 non-operated hips (79%) developed collapse of the femoral head. By survival analysis, there was no significant difference in the time to collapse between the two groups (log-rank test p = 0.79). Core decompression may be effective tin symptomatic relief, but is of no greater value than conservative management in preventing collapse in early osteonecrosis of the femoral head


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 7 | Pages 984 - 988
1 Jul 2010
Guo JJ Tang N Yang HL Tang TS

We compared the outcome of closed intramedullary nailing with minimally invasive plate osteosynthesis using a percutaneous locked compression plate in patients with a distal metaphyseal fracture in a prospective study. A total of 85 patients were randomised to operative stabilisation either by a closed intramedullary nail (44) or by minimally invasive osteosynthesis with a compression plate (41). Pre-operative variables included the patients’ age and the side and pattern of the fracture. Peri-operative variables were the operating time and the radiation time. Postoperative variables were wound problems, the time to union of the fracture, the functional American Orthopaedic Foot and Ankle surgery score and removal of hardware. We found no significant difference in the pre-operative variables or in the time to union in the two groups. However, the mean radiation time and operating time were significantly longer in the locked compression plate group (3.0 vs 2.12 minutes, p < 0.001, and 97.9 vs 81.2 minutes, p < 0.001, respectively). After one year, all the fractures had united. Patients who had intramedullary nailing had a higher mean pain score, but better function, alignment and total American Orthopaedic Foot and Ankle surgery scores, although the differences were not statistically significant (p = 0.234, p = 0.157, p = 0.897, p = 0.177 respectively). Three (6.8%) patients in the intramedullary nailing group and six (14.6%) in the locked compression plate group showed delayed wound healing, and 37 (84.1%) in the former group and 38 (92.7%) in the latter group expressed a wish to have the implant removed. We conclude that both closed intramedullary nailing and a percutaneous locked compression plate can be used safely to treat Orthopaedic Trauma Association type-43A distal metaphyseal fractures of the tibia. However, closed intramedullary nailing has the advantage of a shorter operating and radiation time and easier removal of the implant. We therefore prefer closed intramedullary nailing for patients with these fractures


The Journal of Bone & Joint Surgery British Volume
Vol. 84-B, Issue 6 | Pages 858 - 860
1 Aug 2002
Reed MR Bliss W Sher JL Emmerson KP Jones SMG Partington PF

We undertook a prospective, randomised study of 135 total knee arthroplasties to determine the most accurate and reliable technique for alignment of the tibial prosthesis. Tibial resection was guided by either intramedullary or extramedullary alignment jigs. Of the 135 knees, standardised postoperative radiographs suitable for assessment were available in 100. Correct tibial alignment was found in 85% of the intramedullary group compared with 65% of the extramedullary group (p = 0.019). We conclude that intramedullary guides are superior to extramedullary instruments for alignment of the tibial prosthesis


The Journal of Bone & Joint Surgery British Volume
Vol. 73-B, Issue 1 | Pages 83 - 85
1 Jan 1991
Hooper G Keddell R Penny I

We performed a prospective randomised trial on matched groups of patients with displaced tibial shaft fractures to compare conservative treatment with closed intramedullary nailing. The results showed conclusively that intramedullary nailing gave more rapid union with less malunion and shortening. Nailed patients had less time off work with a more predictable and rapid return to full function. We therefore consider that closed intramedullary nailing is the most efficient treatment for displaced fractures of the tibial shaft


The Journal of Bone & Joint Surgery British Volume
Vol. 75-B, Issue 6 | Pages 918 - 920
1 Nov 1993
Wright K Moran C Briggs P

Exposure to blood is a hazard for all surgeons. We assessed the incidence of glove perforation and needlestick injury from a new blunt taperpoint needle designed to penetrate tissues other than skin with the minimum of force. We performed a prospective, randomised trial comparing the incidence of perforations of surgical gloves with the new needle and a standard cutting needle during wound closure after hip arthroplasties. There was at least one glove perforation in 46 of 69 such procedures (67%). The use of the taperpoint needle produced a significant decrease in perforations (p = 0.049)


The Journal of Bone & Joint Surgery British Volume
Vol. 75-B, Issue 5 | Pages 769 - 771
1 Sep 1993
Milligan K Macafee A Fogarty D Wallace R Ramsey P

A randomised double-blind study was carried out on 60 patients undergoing elective lumbar discectomy. Patients in the study group (n = 30) received an injection of 10 ml of 0.5% bupivacaine into the wound; the control group (n = 30) received none. Postoperative pain was measured by a visual analogue pain scale and by the amount of morphine administered by a patient-controlled analgesia system. Patients in the study group had lower pain scores, used less morphine, waited longer until their first demand for analgesia and reported their postoperative pain to be less severe


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 1 | Pages 37 - 42
1 Jan 2008
Nutton RW van der Linden ML Rowe PJ Gaston P Wade FA

Modifications in the design of knee replacements have been proposed in order to maximise flexion. We performed a prospective double-blind randomised controlled trial to compare the functional outcome, including maximum knee flexion, in patients receiving either a standard or a high flexion version of the NexGen legacy posterior stabilised total knee replacement. A total of 56 patients, half of whom received each design, were assessed pre-operatively and at one year after operation using knee scores and analysis of range of movement using electrogoniometry. For both implant designs there was a significant improvement in the function component of the knee scores (p < 0.001) and the maximum range of flexion when walking on the level, ascending and descending a slope or stairs (all p < 0.001), squatting (p = 0.020) and stepping into a bath (p = 0.024). There was no significant difference in outcome, including the maximum knee flexion, between patients receiving the standard and high flexion designs of this implant


The Journal of Bone & Joint Surgery British Volume
Vol. 73-B, Issue 2 | Pages 307 - 311
1 Mar 1991
Roumen R Hesp W Bruggink E

We report the results of a prospective randomised controlled trial of the management of 101 Colles' fractures in patients over the age of 55 years. Within two weeks of initial reduction 43 fractures had displaced with either more than 10 degrees dorsal angulation or more than 5 mm radial shortening. These patients were randomly divided into two groups: 21 were remanipulated and held by an external fixator; in the control group of 22 patients, the redisplacement was accepted and conservative treatment was continued. Patients treated with external fixation had a good anatomical result, but their function was no better than that of the control group. We found no correlation between final anatomical and functional outcome, and concluded that the severity of the original soft-tissue injury and its complications are the major determinants of functional end result


The Journal of Bone & Joint Surgery British Volume
Vol. 84-B, Issue 2 | Pages 183 - 188
1 Mar 2002
Rogmark C Carlsson Å Johnell O Sernbo I

It remains a matter of debate whether displaced fractures of the neck of the femur should be treated by internal fixation or arthroplasty. We have compared the two methods with regard to complications, mortality and functional outcome. We studied 409 patients, aged 70 years and over, with subcapital fractures graded as Garden 3 or 4, in a two-year prospective multicentre study from 12 Swedish hospitals. They were randomised to internal fixation or arthroplasty. Patients who were mentally confused, bedridden or in a nursing-home were excluded from the survey. After two years the rate of failure was 43% in the internal fixation (IF) and 6% in the arthroplasty group (p < 0.001). In the IF group 36% had impaired walking and 6% had severe pain compared with 25% and 1.5%, respectively, in the arthroplasty group (both p < 0.05). There was no difference in mortality. With a high rate of failure and poor functional outcome after IF, we recommend primary arthroplasty for displaced fractures of the neck of the femur in patients over 70 years of age


The Journal of Bone & Joint Surgery British Volume
Vol. 67-B, Issue 4 | Pages 567 - 571
1 Aug 1985
Ogilvie-Harris D Bauer M Corey P

In a double-blind, randomised, prospective study of 139 patients undergoing arthroscopic meniscectomy, those receiving a prostaglandin inhibitor (naproxen sodium) had significantly less pain, less synovitis and less effusion. They had significantly more rapid return of movement and of quadriceps function; their return to work and to sport also was significantly faster. It is recommended that, provided there are no contraindications, a prostaglandin inhibitor should be used after arthroscopic procedures