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The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 382 - 388
15 Mar 2023
Haque A Parsons H Parsons N Costa ML Redmond AC Mason J Nwankwo H Kearney RS

Aims. The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture. Methods. This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant’s ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years. Results. Overall, 436 patients (65%) completed the final two-year follow-up. The mean difference in OMAS at two years was -0.3 points favouring the plaster cast (95% confidence interval -3.9 to 3.4), indicating no statistically significant difference between the interventions. There was no evidence of differences in patient quality of life (measured using the EuroQol five-dimension five-level questionnaire) or Disability Rating Index. Conclusion. This study demonstrated that patients treated with a removable brace had similar outcomes to those treated with a plaster cast in the first two years after injury. A removable brace is an effective alternative to traditional immobilization in a plaster cast for patients with an ankle fracture. Cite this article: Bone Joint J 2023;105-B(4):382–388


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 696 - 704
1 Jul 2024
Barvelink B Reijman M Smidt S Miranda Afonso P Verhaar JAN Colaris JW

Aims. It is not clear which type of casting provides the best initial treatment in adults with a distal radial fracture. Given that between 32% and 64% of adequately reduced fractures redisplace during immobilization in a cast, preventing redisplacement and a disabling malunion or secondary surgery is an aim of treatment. In this study, we investigated whether circumferential casting leads to fewer fracture redisplacements and better one-year outcomes compared to plaster splinting. Methods. In a pragmatic, open-label, multicentre, two-period cluster-randomized superiority trial, we compared these two types of casting. Recruitment took place in ten hospitals. Eligible patients aged ≥ 18 years with a displaced distal radial fracture, which was acceptably aligned after closed reduction, were included. The primary outcome measure was the rate of redisplacement within five weeks of immobilization. Secondary outcomes were the rate of complaints relating to the cast, clinical outcomes at three months, patient-reported outcome measures (PROMs) (using the numerical rating scale (NRS), the abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), and Patient-Rated Wrist/Hand Evaluation (PRWHE) scores), and adverse events such as the development of compartment syndrome during one year of follow-up. We used multivariable mixed-effects logistic regression for the analysis of the primary outcome measure. Results. The study included 420 patients. There was no significant difference between the rate of redisplacement of the fracture between the groups: 47% (n = 88) for those treated with a plaster splint and 49% (n = 90) for those treated with a circumferential cast (odds ratio 1.05 (95% confidence interval (CI) 0.65 to 1.70); p = 0.854). Patients treated in a plaster splint reported significantly more pain than those treated with a circumferential cast, during the first week of treatment (estimated mean NRS 4.7 (95% CI 4.3 to 5.1) vs 4.1 (95% CI 3.7 to 4.4); p = 0.014). The rate of complaints relating to the cast, clinical outcomes and PROMs did not differ significantly between the groups (p > 0.05). Compartment syndrome did not occur. Conclusion. Circumferential casting did not result in a significantly different rate of redisplacement of the fracture compared with the use of a plaster splint. There were comparable outcomes in both groups. Cite this article: Bone Joint J 2024;106-B(7):696–704


Aims. The aim of this study was to assess and compare active rotation of the forearm in normal subjects after the application of a short-arm cast (SAC) in the semisupination position and a long-arm cast (LAC) in the neutral position. A clinical study was also conducted to compare the functional outcomes of using a SAC in the semisupination position with those of using a LAC in the neutral position in patients who underwent arthroscopic triangular fibrocartilage complex (TFCC) foveal repair. Methods. A total of 40 healthy right-handed volunteers were recruited. Active pronation and supination of the forearm were measured in each subject using a goniometer. In the retrospective clinical study, 40 patients who underwent arthroscopic foveal repair were included. The wrist was immobilized postoperatively using a SAC in the semisupination position (approximately 45°) in 16 patients and a LAC in 24. Clinical outcomes were assessed using grip strength and patient-reported outcomes. The degree of disability caused by cast immobilization was also evaluated when the cast was removed. Results. Supination was significantly more restricted with LACs than with SACs in the semisupination position in male and female patients (p < 0.001 for both). However, pronation was significantly more restricted with SACs in the semisupination position than with LACs in female patients (p = 0.003) and was not significantly different in male patients (p = 0.090). In the clinical study, both groups showed improvement in all parameters with significant differences in grip strength, visual analogue scale scores for pain, modified Mayo Wrist Score, the Disability of the Arm, Shoulder, and Hand (DASH) score, and the Patient-Rated Wrist Evaluation (PRWE) score. No significant postoperative differences were noted between LACs and SACs in the semisupination position. However, the disability caused by immobilization in a cast was significantly higher in patients who had a LAC on the dominant hand (p < 0.001). Conclusion. We found that a SAC in the semisupination position is as effective as a LAC in restricting pronation of the forearm. In addition, postoperative immobilization with a SAC in the semisupination position resulted in comparable pain scores and functional outcomes to immobilization with a LAC after TFCC foveal repair, with less restriction of daily activities. Therefore, we recommend that surgeons consider using a SAC in the semisupination position for postoperative immobilization following TFCC foveal repair for dorsal instability of the distal radioulnar joint. Cite this article: Bone Joint J 2022;104-B(2):249–256


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1277 - 1283
1 Jul 2021
Hinde S Richardson G Fairhurst C Brealey SD Cook L Rangan A Costa ML Dias JJ

Aims. The aim of the Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) was to determine the optimal treatment for adults with a bicortical undisplaced or minimally displaced fracture of the waist of the scaphoid, comparing early surgical fixation with initial cast immobilization, with immediate fixation being offered to patients with nonunion. Methods. A cost-effectiveness analysis was conducted to assess the relative merits of these forms of treatment. The differences in costs to the healthcare system and quality-adjusted life years (QALYs) of the patients over the one-year follow-up of the trial in the two treatment arms were estimated using regression analysis. Results. Our base case analysis found that patients randomized to early surgical fixation had statistically significantly higher mean costs to the NHS of £1,295 more than for the cast immobilization arm (p < 0.001), primarily due to the cost of surgery. They also had a marginally better quality of life, over the period, of 0.0158 QALYs; however, this was not statistically significant (p = 0.379). The mean combined cost per additional QALY was £81,962, well above the accepted threshold for cost-effectiveness used in the UK and internationally. The probability of early surgery being cost-effective in this setting was only 5.6%. Conclusion. Consistent with the clinical findings of SWIFFT, these results indicate that initial cast immobilization of minimally displaced scaphoid fractures, with immediate fixation only offered to patients with nonunion, is the optimal form of treatment, resulting in comparable outcomes with less cost to the healthcare system. Cite this article: Bone Joint J 2021;103-B(7):1277–1283


The Bone & Joint Journal
Vol. 105-B, Issue 9 | Pages 993 - 999
1 Sep 2023
van Delft EAK van Bruggen SGJ van Stralen KJ Bloemers FW Sosef NL Schep NWL Vermeulen J

Aims. There is no level I evidence dealing with the optimal period of immobilization for patients with a displaced distal radial fracture following closed reduction. A shorter period might lead to a better functional outcome due to less stiffness and pain. The aim of this study was to investigate whether this period could be safely reduced from six to four weeks. Methods. This multicentre randomized controlled trial (RCT) included adult patients with a displaced distal radial fracture, who were randomized to be treated with immobilization in a cast for four or six weeks following closed reduction. The primary outcome measure was the Patient-Rated Wrist Evaluation (PRWE) score after follow-up at one year. Secondary outcomes were the abbreviated version of the Disability of Arm, Shoulder and Hand (QuickDASH) score after one year, the functional outcome at six weeks, 12 weeks, and six months, range of motion (ROM), the level of pain after removal of the cast, and complications. Results. A total of 100 patients (15 male, 85 female) were randomized, with 49 being treated with four weeks of immobilization in a cast. A total of 93 completed follow-up. The mean PRWE score after one year was 6.9 (SD 8.3) in the four-week group compared with 11.6 (SD 14.3) in the six-week group. However, this difference of -4.7 (95% confidence interval -9.29 to 0.14) was not clinically relevant as the minimal clinically important difference of 11.5 was not reached. There was no significant difference in the ROM, radiological outcome, level of pain, or complications. Conclusion. In adult patients with a displaced and adequately reduced distal radial fracture, immobilization in a cast for four weeks is safe, and the results are similar to those after a period of immobilization of six weeks. Cite this article: Bone Joint J 2023;105-B(9):993–999


Aims. The study was undertaken to compare the efficacy of Woodcast splints and plaster-of-Paris casts in maintaining correction following sequential manipulation of idiopathic clubfeet. Methods. In this randomized prospective trial, 23 idiopathic clubfeet were immobilized with plaster-of-Paris casts and 23 clubfeet were immobilized with a splint made of Woodcast that encircled only two-thirds the circumference of the limb. The number of casts or splints needed to obtain full correction, the frequency of cast or splint-related complications, and the time taken for application and removal of the casts and splints were compared. Results. The mean number of casts required to obtain full correction of the deformity (Pirani Score 0) was 4.35 (95% confidence interval (CI) 3.74 to 4.95) when plaster-of-Paris was used and 4.87 (95% CI 4.33 to 5.41) when the Woodcast splint was used (p = 0.190). The time required for application and removal of the Woodcast splint were significantly less than that required for application and removal of plaster-of-Paris casts (p < 0.001). Woodcast splint-related complications were not more frequent than plaster-of-Paris cast related complications. Conclusion. Though Woodcast splints covering two-thirds of the circumference of the lower limbs of infants were effective in maintaining the correction of clubfoot deformity during serial manipulation and casting treatment, the superiority of Woodcasts over plaster-of-Paris could not be established. Cite this article: Bone Joint J 2020;102-B(10):1399–1404


The Bone & Joint Journal
Vol. 101-B, Issue 6 | Pages 691 - 694
1 Jun 2019
Tonge XN Widnall JC Jackson G Platt S

Aims. To our knowledge, there is currently no information available about the rate of venous thromboembolism (VTE) or recommendations regarding chemoprophylaxis for patients whose lower limb is immobilized in a plaster cast. We report a retrospective case series assessing the rate of symptomatic VTE in patients treated with a lower limb cast. Given the complex, heterogeneous nature of this group of patients, with many risk factors for VTE, we hypothesized that the rate of VTE would be higher than in the general population. Patients and Methods. Patients treated with a lower limb cast between 2006 and 2018 were identified using plaster room records. Their electronic records and radiological reports were reviewed for details about their cast, past medical history, and any VTE recorded in our hospital within a year of casting. Results. There were 136 episodes of casting in 100 patients. The mean age was 55 years (22 to 91). The mean time in a cast was 45 days (five days to eight months). A total of 76 patients had neuropathy secondary to diabetes. No patient received chemical thromboprophylaxis while in a cast. One VTE (0.7% of casting episodes) was documented. This was confirmed by Doppler scan nine days after removing the cast. Conclusion. The frequency of VTE was higher than that of the general population (0.05%); this is most likely attributable to our patients’ apparent increase in VTE risk as suggested by The National Institute for Health and Care Excellence (NICE). These findings suggest that thromboprophylaxis is not routinely indicated in patients who undergo immobilization of the lower limb in a cast, although the risks of VTE should be assessed. While the cast itself does not pose an increased risk, other pathologies, such as active cancer, mean that each individual case needs to be considered on their merit. Cite this article: Bone Joint J 2019;101-B:691–694


The Bone & Joint Journal
Vol. 95-B, Issue 9 | Pages 1285 - 1289
1 Sep 2013
Inglis M McClelland B Sutherland LM Cundy PJ

Fractures of the forearm (radius or ulna or both) in children have traditionally been immobilised in plaster of Paris (POP) but synthetic cast materials are becoming more popular. There have been no randomised studies comparing the efficacy of these two materials. The aim of this study was to investigate which cast material is superior for the management of these fractures. We undertook a single-centre prospective randomised trial involving 199 patients with acute fractures of the forearm requiring general anaesthesia for reduction. Patients were randomised by sealed envelope into either a POP or synthetic group and then underwent routine closed reduction and immobilisation in a cast. The patients were reviewed at one and six weeks. A satisfaction questionnaire was completed following the removal of the cast. All clinical complications were recorded and the cast indices were calculated. There was an increase in complications in the POP group. These complications included soft areas of POP requiring revision and loss of reduction with some requiring re-manipulation. There was an increased mean padding index in the fractures that lost reduction. Synthetic casts were preferred by the patients. This study indicates that the clinical outcomes and patient satisfaction are superior using synthetic casts with no reduction in safety. Cite this article: Bone Joint J 2013;95-B:1285–9


The Bone & Joint Journal
Vol. 95-B, Issue 12 | Pages 1714 - 1720
1 Dec 2013
Hamilton TW Hutchings L Alsousou J Tutton E Hodson E Smith CH Wakefield J Gray B Symonds S Willett K

We investigated whether, in the management of stable paediatric fractures of the forearm, flexible casts that can be removed at home are as clinically effective, cost-effective and acceptable to both patient and parent as management using a cast conventionally removed in hospital. A single-centre randomised controlled trial was performed on 317 children with a mean age of 9.3 years (2 to 16). No significant differences were seen in the change in Childhood Health Assessment Questionnaire index score (p = 0.10) or EuroQol 5-Dimensions domain scores between the two groups one week after removal of the cast or the absolute scores at six months. There was a significantly lower overall median treatment cost in the group whose casts were removed at home (£150.88 (. sem. 1.90) vs £251.62 (. sem. 2.68); p <  0.001). No difference was seen in satisfaction between the two groups (p = 0.48). Cite this article: Bone Joint J 2013;95-B:1714–20


The Journal of Bone & Joint Surgery British Volume
Vol. 82-B, Issue 2 | Pages 228 - 232
1 Mar 2000
Tanaka H Nagata K Goto T Hoshiko H Inoue A

We assessed the unloading effect of the patellar tendon-bearing (PTB) cast in five healthy volunteers using a new system for analysis of dynamic plantar pressure. We devised a method to improve the unloading effect of the PTB cast, and tested this using the same system. Our findings showed that the conventional PTB cast only achieved unloading of 30% of the body-weight and that the part of the cast on the leg had a more important role in the unloading than that which was in contact with the patellar tendon. When the depth of the free space under the foot inside the PTB cast was 1, 2 and 3 cm, the unloading effect was 60%, 80% and 98%, respectively. The unloading effect of the conventional PTB cast was disappointing at only 30% of body-weight. It was improved by producing a space between the sole of the foot and the cast, and was adjustable by altering the depth of this space


The Bone & Joint Journal
Vol. 98-B, Issue 6 | Pages 806 - 811
1 Jun 2016
Akimau PI Cawthron KL Dakin WM Chadwick C Blundell CM Davies MB

Aims. The purpose of this study was to compare symptomatic treatment of a fracture of the base of the fifth metatarsal with immobilisation in a cast. Our null hypothesis was that immobilisation gave better patient reported outcome measures (PROMs). The alternative hypothesis was that symptomatic treatment was not inferior. Patients and Methods. A total of 60 patients were randomised to receive four weeks of treatment, 36 in a double elasticated bandage (symptomatic treatment group) and 24 in a below-knee walking cast (immobilisation group). The primary outcome measure used was the validated Visual Analogue Scale Foot and Ankle (VAS-FA) Score. Data were analysed by a clinician, blinded to the form of treatment, at presentation and at four weeks, three months and six months after injury. Loss to follow-up was 43% at six months. Multiple imputations missing data analysis was performed. Results. At four weeks and six months, symptomatic treatment proved non-inferior in terms of primary outcome. Take home message: Immobilisation is no better than symptomatic treatment in the management of a fracture of the base of the fifth metatarsal when judged by PROMs. Significant loss to follow-up with this injury could be expected in longer term. Cite this article: Bone Joint J 2016;98-B:806–11


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 5 | Pages 646 - 650
1 May 2010
Healy B Beasley R Weatherall M

We report an audit of 208 patients with a mean age of 39 years (16 to 65) attending the Orthopaedic Assessment Unit at the Wellington Hospital between January 2006 and December 2007 with an injury of the tendo Achillis requiring immobilisation in a cast. Information on assessment of venous thromboembolism (VTE) risk, prophylactic measures and VTE events for all patients was obtained from the medical records. A VTE risk factor was documented in the records of three (1%) patients. One of the 208 patients received aspirin prophylaxis; none received low molecular weight heparin. In all, 13 patients (6.3%, 95% confidence interval 3.4 to 10.5) developed symptomatic VTE during immobilisation in a cast, including six with a distal deep-vein thrombosis (DVT), four with a proximal DVT, and three with a confirmed pulmonary embolus. This incidence of symptomatic VTE is similar to that reported following elective hip replacement. We propose that consideration is given to VTE prophylaxis during prolonged immobilisation of the lower limbs in a cast, to ensure that the same level of protection is provided as for patients undergoing elective hip replacement


The Bone & Joint Journal
Vol. 98-B, Issue 11 | Pages 1548 - 1553
1 Nov 2016
Tennant SJ Eastwood DM Calder P Hashemi-Nejad A Catterall A

Aims. Our aim was to assess the effectiveness of a protocol involving a standardised closed reduction for the treatment of children with developmental dysplasia of the hip (DDH) in maintaining reduction and to report the mid-term results. Methods. A total of 133 hips in 120 children aged less than two years who underwent closed reduction, with a minimum follow-up of five years or until subsequent surgery, were included in the study. The protocol defines the criteria for an acceptable reduction and the indications for a concomitant soft-tissue release. All children were immobilised in a short- leg cast for three months. Arthrograms were undertaken at the time of closed reduction and six weeks later. Follow-up radiographs were taken at six months and one, two and five years later and at the latest follow-up. The Tönnis grade, acetabular index, Severin grade and signs of osteonecrosis were recorded. Results. A total of 67 hips (51%) were Tönnis grade 3/4 hips. By 12 months, 20 reductions (15%) had not been maintained, and these required open reduction. In all, 55% of these were Severin 1; the others were Severin 2, due to minor acetabular dysplasia. Of the 113 successful closed reductions, 98 hips (87%) were Severin 1. Surgery for residual DDH was offered for ten hips. Osteonecrosis was seen in 32 hips (29%) but was transient in 28. In total, two children (1.5%) had severe osteonecrosis. Bilateral dislocations were significantly more likely to fail and most Tönnis 4 hips failed. Conclusion. Closed reduction, with concomitant adductor and psoas release when required and the use of a short leg plaster of Paris cast for three months, can produce good mid-term results in children with DDH aged less than two years. This protocol is not recommended for Tönnis 4 hips. Cite this article: Bone Joint J 2016;98-B:1548–53


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 10 | Pages 1340 - 1343
1 Oct 2007
Patil S Gandhi J Curzon I Hui ACW

Stable fractures of the ankle can be successfully treated non-operatively by a below-knee plaster cast. In some centres, patients with this injury are routinely administered low-molecular-weight heparin, to reduce the risk of deep-vein thrombosis (DVT). We have assessed the incidence of DVT in 100 patients in the absence of any thromboprophylaxis. A colour Doppler duplex ultrasound scan was done at the time of the removal of the cast. Five patients did develop DVT, though none had clinical signs suggestive of it. One case involved the femoral and another the popliteal vein. No patient developed pulmonary embolism. As the incidence of DVT after ankle fractures is low, we do not recommend routine thromboprophylaxis


The Journal of Bone & Joint Surgery British Volume
Vol. 73-B, Issue 1 | Pages 92 - 95
1 Jan 1991
Hullin M Robb J

Rockers are applied to lower limb casts to assist walking but there is little information on their biomechanical effects. The performances of 10 commercially available rockers were compared. They were applied to a below-knee cast worn by a normal subject who was also tested walking in the cast alone. Gait analysis was used to evaluate kinematic and kinetic data. The design of rocker had no effect upon the kinematics of walking. However, using new criteria for kinetic assessment of rocker function (tibial floor angular velocity and centre of pressure progression), most designs had a deleterious effect on the biomechanics of gait. Only two rockers approached the ideal kinetic criteria


The Journal of Bone & Joint Surgery British Volume
Vol. 83-B, Issue 3 | Pages 388 - 390
1 Apr 2001
Katz K Fogelman R Attias J Baron E Soudry M

We have had experience of an 18-month-old boy with a cardiomyopathy who died a few minutes after removal of his cast with a saw, apparently from a malignant cardiac arrhythmia triggered by anxiety. We therefore examined the anxiety reaction to this method of removal of a plaster cast in 20 healthy children; ten were provided with hearing protectors and ten were not. The level of anxiety was assessed by measuring the heart rate, a known physiological indicator of anxiety, before, during and five minutes after removal of the cast. The noise level was also measured. The results showed a mean increase in heart rate during the procedure of 27.9 beats per minute (bpm) (26.9%) in the children with no hearing protectors and 10.4 bpm (11.1%) in children who used hearing protectors (p < 0.001). Five minutes after the procedure the heart rate had returned to the baseline rate in all patients. We recommend that hearing protectors should be used in children undergoing removal of a plaster cast to decrease the anxiety reaction. If possible, clinicians should avoid the use of a saw for this purpose in children with a cardiomyopathy


The Journal of Bone & Joint Surgery British Volume
Vol. 73-B, Issue 2 | Pages 299 - 301
1 Mar 1991
Walker J Rang M

Fractures of the proximal forearm in young children may be unstable with the elbow flexed but stable with it in extension. Fifteen such fractures were managed by immobilisation in long-arm casts with the elbow extended. Only one patient had more than 15 degrees angulation at the time of bony union. All obtained normal elbow movement at two weeks and full forearm rotation at follow-up. No casts fell off. The extended elbow cast is awkward but it provides an alternative to internal fixation for some unstable fractures


The Bone & Joint Journal
Vol. 104-B, Issue 5 | Pages 529 - 531
1 May 2022
Rajput V Haddad FS


The Bone & Joint Journal
Vol. 104-B, Issue 8 | Pages 953 - 962
1 Aug 2022
Johnson NA Fairhurst C Brealey SD Cook E Stirling E Costa M Divall P Hodgson S Rangan A Dias JJ

Aims

There has been an increasing use of early operative fixation for scaphoid fractures, despite uncertain evidence. We conducted a meta-analysis to evaluate up-to-date evidence from randomized controlled trials (RCTs), comparing the effectiveness of the operative and nonoperative treatment of undisplaced and minimally displaced (≤ 2 mm displacement) scaphoid fractures.

Methods

A systematic review of seven databases was performed from the dates of their inception until the end of March 2021 to identify eligible RCTs. Reference lists of the included studies were screened. No language restrictions were applied. The primary outcome was the patient-reported outcome measure of wrist function at 12 months after injury. A meta-analysis was performed for function, pain, range of motion, grip strength, and union. Complications were reported narratively.


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 12 | Pages 1663 - 1665
1 Dec 2005
Zeifang F Carstens C Schneider S Thomsen M

Continuous passive motion has been shown to be effective in the conservative treatment of idiopathic club foot. We wished to determine whether its use after operation could improve the results in resistant club feet which required an extensive soft-tissue release. There were 50 feet in the study. Posteromedial lateral release was performed in 39 feet but two were excluded due to early relapse. The mean age at surgery was eight months (5 to 12). Each foot was assigned a Dimeglio club foot score, which was used as a primary outcome measure, before operation and at 6, 12, 18 and 44 months after. Nineteen feet were randomly selected to receive continuous passive motion and 18 had standard immobilisation in a cast. After surgery and subsequent immobilisation in a cast the Dimeglio club foot score improved from 10.3 before to 4.17 by 12 months and to 3.89 at 48 months. After operation followed by continuous passive motion the score improved from 9.68 before to 3.11 after 12 months, but deteriorated to 4.47 at 48 months. Analysis of variance adjusted for baseline values indicated a significantly better score in those having continuous passive motion up to one year after surgery, but after 18 and 48 months the outcomes were the same in both groups