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The Bone & Joint Journal
Vol. 95-B, Issue 3 | Pages 391 - 395
1 Mar 2013
Klatte TO Junghans K Al-Khateeb H Rueger JM Gehrke T Kendoff D Neumann J

There have been only a few small studies of patients with an infected shoulder replacement treated with a single-stage exchange procedure. We retrospectively reviewed 35 patients (19 men and 16 women) with a peri-prosthetic infection of the shoulder who were treated in this way. A total of 26 were available for clinical examination; three had died, two were lost to follow-up and four patients had undergone revision surgery. The mean follow-up time was 4.7 years (1.1 to 13.25), with an infection-free survival of 94%. The organisms most commonly isolated intra-operatively were Staphylococcus epidermidis and Propionibacterium acnes; two patients developed a recurrent infection. Three different types of prosthesis were used: a hemiarthroplasty, a hemiarthroplasty with a bipolar head and reverse prosthesis. The mean Constant-Murley score at final follow-up was 43.3 (14 to 90) for patients with a hemiarthroplasty, 56 (40 to 88) for those with a hemiarthroplasty with a bipolar head and 61 (7 to 90) for those with a reverse prosthesis. The mean hospital stay was 10.6 days (5 to 29). Single-stage exchange is a successful and practical treatment for patients with peri-prosthetic infection of the shoulder. Cite this article: Bone Joint J 2013;95-B:391–5


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 6 | Pages 814 - 818
1 Jun 2005
Ince A Seemann K Frommelt L Katzer A Loehr JF

There are few reports in the literature of the diagnosis and treatment of the infected shoulder arthroplasty. Most deal with resection arthroplasty and two-stage exchange surgery. We present our results of one-stage exchange operation as treatment for the infected shoulder arthroplasty. Our group comprised 16 patients (ten men, six women) with 16 infected arthroplasties. By the time of follow-up, two patients had died (mean 5.8 years), two could not be located and three had already undergone revision surgery. Nine patients were thus available for clinical examination and assessment. The infections were largely caused by staphylococci, Propionibacterium species and streptococci. Two were early infections (within three months of surgery) and 14 were late infections. The mean follow-up was 5.8 years (13 months to 13.25 years) when the mean Constant-Murley score was 33.6 points and the mean University College of Los Angeles score 18.3 points. Further revision was performed in three patients. One sustained a peri-prosthetic humeral fracture, another developed an acromial pseudarthrosis after transacromial surgery and the third suffered recurrent dislocations. No patient had a recurrence of infection. A one-stage exchange procedure using antibiotic-loaded bone cement eradicated infection in all our patients and we suggest that such a procedure is at least as successful as either a resection arthroplasty or a two-stage exchange in the management of the infected shoulder arthroplasty


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 10 | Pages 1341 - 1346
1 Oct 2006
Gille J Ince A González O Katzer A Loehr JF

This study reviews the predisposing features, the clinical, and laboratory findings at the time of diagnosis and the results of single-stage revision of prosthetic replacement of the elbow for infection. Deep infection occurred in six of 305 (1.9%) primary total elbow replacements. The mean follow-up after revision was 6.8 years (6 months to 16 years) and the mean age at the time of revision was 62.7 years (56 to 74). All six cases with infection had rheumatoid arthritis and had received steroid therapy. The infective organism was Staphylococcus aureus. Four of the six elbows had a developed radiolucency around one component or the other. Successful single-stage exchange arthroplasty was carried out with antibiotic-loaded cement in five of the six cases. In one, the revision prosthesis had to be removed following recurrence of the infection. The functional result was good in three elbows, fair in one, poor in one and fair in the resection arthroplasty


The Bone & Joint Journal
Vol. 96-B, Issue 11 | Pages 1530 - 1534
1 Nov 2014
Uehara K Yasunaga H Morizaki Y Horiguchi H Fushimi K Tanaka S

Necrotising soft-tissue infections (NSTIs) of the upper limb are uncommon, but potentially life-threatening. We used a national database to investigate the risk factors for amputation of the limb and death. . We extracted data from the Japanese Diagnosis Procedure Combination database on 116 patients (79 men and 37 women) who had a NSTI of the upper extremity between 2007 and 2010. The overall in-hospital mortality was 15.5%. Univariate analysis of in-hospital mortality showed that the significant variables were age (p = 0.015), liver dysfunction (p = 0.005), renal dysfunction (P < 0.001), altered consciousness (p = 0.049), and sepsis (p = 0.021). Logistic regression analysis showed that the factors associated with death in hospital were age over 70 years (Odds Ratio (OR) 6.6; 95% confidence interval (CI) 1.5 to 28.2; p = 0.011) and renal dysfunction (OR 15.4; 95% CI 3.8 to 62.8; p < 0.001). Univariate analysis of limb amputation showed that the significant variables were diabetes (p = 0.017) mellitus and sepsis (p = 0.001). Multivariable logistic regression analysis showed that the factors related to limb amputation were sepsis (OR 1.8; 95% CI 1.5 to 24.0; p = 0.013) and diabetes mellitus (OR 1.6; 95% CI 1.1 to 21.1; p = 0.038). . For NSTIs of the upper extremity, advanced age and renal dysfunction are both associated with a higher rate of in-hospital mortality. Sepsis and diabetes mellitus are both associated with a higher rate of amputation. Cite this article: Bone Joint J 2014;96-B:1530–4


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 3 | Pages 336 - 342
1 Mar 2008
Cuff DJ Virani NA Levy J Frankle MA Derasari A Hines B Pupello DR Cancio M Mighell M

We retrospectively reviewed 21 patients (22 shoulders) who presented with deep infection after surgery to the shoulder, 17 having previously undergone hemiarthroplasty and five open repair of the rotator cuff. Nine shoulders had undergone previous surgical attempts to eradicate their infection. The diagnosis of infection was based on a combination of clinical suspicion (16 shoulders), positive frozen sections (> 5 polymorphonuclear leukocytes per high-power field) at the time of revision (15 shoulders), positive intra-operative cultures (18 shoulders) or the pre-operative radiological appearances. The patients were treated by an extensive debridement, intravenous antibiotics, and conversion to a reverse shoulder prosthesis in either a single- (10 shoulders) or a two-stage (12 shoulders) procedure. At a mean follow-up of 43 months (25 to 66) there was no evidence of recurrent infection. All outcome measures showed statistically significant improvements. Mean abduction improved from 36.1° (. sd. 27.8) pre-operatively to 75.7° (. sd. 36.0) (p < 0.0001), the mean forward flexion from 43.1° (. sd. 33.5) to 79.5° (. sd. 43.2) (p = 0.0003), and mean external rotation from 10.2° (. sd. 18.7) to 25.4° (. sd. 23.5) (p = 0.0037). There was no statistically significant difference in any outcome between the single-stage and the two-stage group


Bone & Joint Research
Vol. 13, Issue 10 | Pages 596 - 610
21 Oct 2024
Toegel S Martelanz L Alphonsus J Hirtler L Gruebl-Barabas R Cezanne M Rothbauer M Heuberer P Windhager R Pauzenberger L

Aims

This study aimed to define the histopathology of degenerated humeral head cartilage and synovial inflammation of the glenohumeral joint in patients with omarthrosis (OmA) and cuff tear arthropathy (CTA). Additionally, the potential of immunohistochemical tissue biomarkers in reflecting the degeneration status of humeral head cartilage was evaluated.

Methods

Specimens of the humeral head and synovial tissue from 12 patients with OmA, seven patients with CTA, and four body donors were processed histologically for examination using different histopathological scores. Osteochondral sections were immunohistochemically stained for collagen type I, collagen type II, collagen neoepitope C1,2C, collagen type X, and osteocalcin, prior to semiquantitative analysis. Matrix metalloproteinase (MMP)-1, MMP-3, and MMP-13 levels were analyzed in synovial fluid using enzyme-linked immunosorbent assay (ELISA).


Bone & Joint Research
Vol. 10, Issue 5 | Pages 298 - 306
1 May 2021
Dolkart O Kazum E Rosenthal Y Sher O Morag G Yakobson E Chechik O Maman E

Aims

Rotator cuff (RC) tears are common musculoskeletal injuries which often require surgical intervention. Noninvasive pulsed electromagnetic field (PEMF) devices have been approved for treatment of long-bone fracture nonunions and as an adjunct to lumbar and cervical spine fusion surgery. This study aimed to assess the effect of continuous PEMF on postoperative RC healing in a rat RC repair model.

Methods

A total of 30 Wistar rats underwent acute bilateral supraspinatus tear and repair. A miniaturized electromagnetic device (MED) was implanted at the right shoulder and generated focused PEMF therapy. The animals’ left shoulders served as controls. Biomechanical, histological, and bone properties were assessed at three and six weeks.


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 6 | Pages 817 - 822
1 Jun 2010
Beekman PDA Katusic D Berghs BM Karelse A De Wilde L

We retrospectively reviewed 11 consecutive patients with an infected reverse shoulder prosthesis. Patients were assessed clinically and radiologically, and standard laboratory tests were carried out. Peroperative samples showed Propionbacterium acnes in seven, coagulase-negative Staphylococcus in five, methicillin-resistant staphylococcus aureus in one and Escherichia coli in one. Two multibacterial and nine monobacterial infections were seen. Post-operatively, patients were treated with intravenous cefazolin for at least three days and in all antibiotic therapy was given for at least three months. Severe pain (3 of 11) or severe limitation of function (3 of 11) are not necessarily seen. A fistula was present in eight, but function was not affected. All but one patient were considered free of infection after one-stage revision at a median follow-up of 24 months, and without antibiotic treatment for a minimum of six months. One patient had a persistent infection despite a second staged revision, but is now free of infection with a spacer. Complications included posterior dislocation in one, haematoma in one and a clavicular fracture in one. At the most recent follow-up the median post-operative Constant-Murley score was 55, 6% adjusted for age, gender and dominance. A one-stage revision arthroplasty reduces the cost and duration of treatment. It is reliable in eradicating infection and good functional outcomes can be achieved


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 4 | Pages 460 - 465
1 Apr 2008
Strickland JP Sperling JW Cofield RH

While frequently discussed as a standard treatment for the management of an infected shoulder replacement, there is little information on the outcome of two-stage re-implantation. We examined the outcome of 17 consecutive patients (19 shoulders) who were treated between 1995 and 2004 with a two-stage re-implantation for the treatment of a deep-infection after shoulder replacement. All 19 shoulders were followed for a minimum of two years or until the time of further revision surgery. The mean clinical follow-up was for 35 months (24 to 80). The mean radiological follow-up was 27 months (7 to 80). There were two excellent results, four satisfactory and 13 unsatisfactory. In 12 of the 19 shoulders (63%) infection was considered to be eradicated. The mean pain score improved from 4.2 (3 to 5 (out of 5)) to 1.8 (1 to 4). The mean elevation improved from 42° (0° to 140°) to 89° (0° to 165°), mean external rotation from 30° (0° to 90°) to 43° (0° to 90°), and mean internal rotation from the sacrum to L5. There were 14 complications. Our study suggests that two-stage re-implantation for an infected shoulder replacement is associated with a high rate of unsatisfactory results, marginal success at eradicating infection and a high complication rate


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 4 | Pages 509 - 514
1 Apr 2006
Aldridge JM Lightdale NR Mallon WJ Coonrad RW

There have been few reports in the literature of total elbow arthroplasty extending beyond 10 to 15 years. We reviewed 40 patients (41 elbows) with a mean age of 56 years (19 to 83) who had undergone a Coonrad/Coonrad-Morrey elbow arthroplasty by one surgeon for various diagnoses between 1974 and 1994. Surgical selection excluded patients with previous elbow infection or who refused to accept a sedentary level of elbow activity postoperatively. Objective data were collected from charts, radiographs, clinical photographs and supplemented by the referring orthopaedic surgeons’ records and radiographs if health or distance prevented a patient from returning for final review. Subjective outcome was defined by patient satisfaction. Of the 41 elbows, 21 were functional between 10 and 14 years after operation, ten between 15 and 19 years and ten between 20 and 31 years. There were 14 complications and 13 revisions, but no cases of acute infection, or permanent removal of any implant


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 7 | Pages 950 - 954
1 Jul 2005
Khatri M Stirrat AN

We present the outcome of 47 Souter-Strathclyde replacements of the elbow with a mean follow-up of 82 months (12 to 129). The clinical results were assessed using a condition-specific outcome measure. The mean total score (maximum 100) before the operation was 47.21 and improved to 79.92 (p < 0.001). The mean pain score (maximum 50) improved from 21.41 to 46.70 (p < 0.001) and the mean functional component of the score (maximum 30) from 11.19 to 18.65 (p < 0.001). There was negligible change in the score for the range of movement although a significant improvement in mean flexion from 124° to 136° was noted (p < 0.001). Revision surgery was required in four patients, for dislocation, wound dehiscence and early infection in one, late infection in two and aseptic loosening in one. The cumulative survival was 75% at nine years for all causes of failure and 97% at ten years for aseptic loosening alone. Our study demonstrates the value of the Souter-Strathclyde total elbow arthroplasty in providing relief from pain and functional improvement in rheumatoid patients


Bone & Joint Research
Vol. 8, Issue 3 | Pages 118 - 125
1 Mar 2019
Doi N Izaki T Miyake S Shibata T Ishimatsu T Shibata Y Yamamoto T

Objectives

Indocyanine green (ICG) fluorescence angiography is an emerging technique that can provide detailed anatomical information during surgery. The purpose of this study is to determine whether ICG fluorescence angiography can be used to evaluate the blood flow of the rotator cuff tendon in the clinical setting.

Methods

Twenty-six patients were evaluated from October 2016 to December 2017. The participants were categorized into three groups based on their diagnoses: the rotator cuff tear group; normal rotator cuff group; and adhesive capsulitis group. After establishing a posterior standard viewing portal, intravenous administration of ICG at 0.2 mg/kg body weight was performed, and fluorescence images were recorded. The time from injection of the drug to the beginning of enhancement of the observed area was measured. The hypovascular area in the rotator cuff was evaluated, and the ratio of the hypovascular area to the anterolateral area of the rotator cuff tendon was calculated (hypovascular area ratio).


The Journal of Bone & Joint Surgery British Volume
Vol. 80-B, Issue 4 | Pages 614 - 619
1 Jul 1998
Baksi DP

From 1984 to 1995, 68 ankylosed elbows and 11 which were unstable after trauma were replaced in India by Baksi sloppy hinge prostheses. The mean age of the patients was 28.6 years (17 to 70) and the mean follow-up 9.6 years (2 to 13.5). Of the 68 ankylosed elbows, 59 (87%) regained a mean arc of painless movement of 88.5° (27 to 115). The mean improvement of supination was 24° and of pronation 16.5°. There were 54 good results (80%), eight fair and three poor. There were two complete failures due to infection, and one due to a broken humeral stem. Of the 11 unstable elbows, the nine with good results had a mean arc of 125° (15 to 140) of painless stable movement, with a mean improvement in supination of 26° and of pronation of 19.5°. There was one fair result and one failure due to loosening with subsequent late infection. There were significant complications in 14 cases with infection in seven and aseptic loosening in four. Patients with loosening or late removal of the prosthesis often retained reasonably stable elbow movement because periprosthetic fibrosis had connected the approximated bone ends, and muscle balance had been restored


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 10 | Pages 1382 - 1389
1 Oct 2012
Sewell MD Kang SN Al-Hadithy N Higgs DS Bayley I Falworth M Lambert SM

There is little information about the management of peri-prosthetic fracture of the humerus after total shoulder replacement (TSR). This is a retrospective review of 22 patients who underwent a revision of their original shoulder replacement for peri-prosthetic fracture of the humerus with bone loss and/or loose components. There were 20 women and two men with a mean age of 75 years (61 to 90) and a mean follow-up 42 months (12 to 91): 16 of these had undergone a previous revision TSR. Of the 22 patients, 12 were treated with a long-stemmed humeral component that bypassed the fracture. All their fractures united after a mean of 27 weeks (13 to 94). Eight patients underwent resection of the proximal humerus with endoprosthetic replacement to the level of the fracture. Two patients were managed with a clam-shell prosthesis that retained the original components. The mean Oxford shoulder score (OSS) of the original TSRs before peri-prosthetic fracture was 33 (14 to 48). The mean OSS after revision for fracture was 25 (9 to 31). Kaplan-Meier survival using re-intervention for any reason as the endpoint was 91% (95% confidence interval (CI) 68 to 98) and 60% (95% CI 30 to 80) at one and five years, respectively. There were two revisions for dislocation of the humeral head, one open reduction for modular humeral component dissociation, one internal fixation for nonunion, one trimming of a prominent screw and one re-cementation for aseptic loosening complicated by infection, ultimately requiring excision arthroplasty. Two patients sustained nerve palsies. Revision TSR after a peri-prosthetic humeral fracture associated with bone loss and/or loose components is a salvage procedure that can provide a stable platform for elbow and hand function. Good rates of union can be achieved using a stem that bypasses the fracture. There is a high rate of complications and function is not as good as with the original replacement


The Bone & Joint Journal
Vol. 95-B, Issue 5 | Pages 664 - 667
1 May 2013
Rashid A Christofi T Thomas M

Lateral clavicular physeal injuries in adolescents are frequently misinterpreted as acromioclavicular dislocations. There are currently no clear guidelines for the management of these relatively rare injuries. Non-operative treatment can result in a cosmetic deformity, warranting resection of the non-remodelled original lateral clavicle. However, fixation with Kirschner (K)-wires may be associated with infection and/or prominent metalwork. We report our experience with a small series of such cases. Between October 2008 and October 2011 five patients with lateral clavicular physeal fractures (types III, IV and V) presented to our unit. There were four boys and one girl with a mean age of 12.8 years (9 to 14). Four fractures were significantly displaced and treated operatively using a tension band suture technique. One grade III fracture was treated conservatively. The mean follow-up was 26 months (6 to 42). All patients made an uncomplicated recovery. The mean time to discharge was three months. The QuickDASH score at follow-up was 0 for each patient. No patient developed subsequent growth disturbances. We advocate the surgical treatment of significantly displaced Grade IV and V fractures to avoid cosmetic deformity. A tension band suture technique avoids the problems of retained metalwork and the need for a secondary procedure. Excellent clinical and radiological results were seen in all our patients. Cite this article: Bone Joint J 2013;95-B:664–7


The Journal of Bone & Joint Surgery British Volume
Vol. 85-B, Issue 3 | Pages 351 - 353
1 Apr 2003
Espag MP Back DL Clark DI Lunn PG

We have carried out a retrospective review of 11 Souter-Strathclyde primary total elbow arthroplasties in ten patients with osteoarthritis, over a period of nine years. The diagnosis was primary osteoarthritis in nine elbows and post-traumatic arthritis in two. The mean follow-up was 68 months (15 to 117). Although no patient was symptomatic, radiological review revealed evidence of loosening affecting three humeral and two ulnar components, one of which subsequently failed and was revised at 97 months. There were no dislocations, deep infections or mechanical failures. Complications included two superficial wound infections and two neurapraxias of the ulnar nerve which resolved. This study shows that the unlinked Souter-Strathclyde total elbow arthroplasty can be considered for patients with osteoarthritis and gives good symptomatic relief and improvement in function


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 5 | Pages 661 - 667
1 May 2010
van Riet RP Sanchez-Sotelo J Morrey BF

There is little information available at present regarding the mechanisms of failure of modern metallic radial head implants. Between 1998 and 2008, 44 consecutive patients (47 elbows) underwent removal of a failed metallic radial head replacement. In 13 patients (13 elbows) the initial operation had been undertaken within one week of a fracture of the radial head, at one to six weeks in seven patients (seven elbows) and more than six weeks (mean of 2.5 years (2 to 65 months)) in 22 patients (25 elbows). In the remaining two elbows the replacement was inserted for non-traumatic reasons. The most common indication for further surgery was painful loosening (31 elbows). Revision was undertaken for stiffness in 18 elbows, instability in nine, and deep infection in two. There were signs of over-lengthening of the radius in 11 elbows. Degenerative changes were found in all but one. Only three loose implants had been fixed with cement. Instability was not identified in any of the bipolar implants


The Journal of Bone & Joint Surgery British Volume
Vol. 84-B, Issue 1 | Pages 77 - 82
1 Jan 2002
Ikävalko M Lehto MUK Repo A Kautiainen H Hämäläinen M

We present the results of 525 primary Souter elbow arthroplasties undertaken in 406 patients between 1982 and 1997. There were 372 women and 34 men with a mean age of 57 years; 119 patients had a bilateral procedure. The elbows were affected by chronic inflammatory disease, usually rheumatoid arthritis, which had been present for a mean of 24.7 years (2 to 70). In about 30% the joints were grossly destroyed with significant loss of bone. In 179 elbows the ulnar components were metal-backed and retentive; in the remaining 346, with better bone stock, non-retentive, all-polyethylene prostheses were used. Because of complications, 108 further operations were required in 82 patients. During the early years the incidence of complications was higher. Dislocation was the indication for 30 further procedures in 26 patients. Thirty patients underwent 33 revision procedures for aseptic loosening, 12 had 29 operations because of deep infection, two for superficial infection, and 14 further operations were done for other reasons. The cumulative rate of success, without aseptic loosening, five and ten years after surgery, was 96% and 85%, respectively


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 10 | Pages 1397 - 1402
1 Oct 2010
Nada AN Debnath UK Robinson DA Jordan C

We describe the clinical outcome of a technique of surgical augmentation of chronic massive tears of the rotator cuff using a polyester ligament (Dacron) in 21 symptomatic patients (14 men, seven women) with a mean age of 66.5 years (55.0 to 85.0). All patients had MRI and arthroscopic evidence of chronic massive tears. The clinical outcome was assessed using the Constant and Murley and patient satisfaction scores at a mean follow-up of 36 months (30 to 46). The polyester ligament (500 mm × 10 mm) was passed into the joint via the portal of Neviaser, medial to the tear through healthy cuff. The two ends of the ligament holding the cuff were passed through tunnels made in the proximal humerus at the footprint of the insertion of the cuff. The ligament was tied with a triple knot over the humeral cortex. All the patients remained free from pain (p < 0.001) with improvement in function (p < 0.001) and range of movement (p < 0.001). The mean pre-operative and post-operative Constant scores were 46.7 (39.0 to 61.0) and 85.4 (52.0 to 96.0), respectively (p < 0.001). The mean patient satisfaction score was 90%. There were two failures, one due to a ruptured ligament after one year and the other due to deep-seated infection. The MR scan at the final follow-up confirmed intact and thickened bands in 15 of 17 patients. This technique of augmentation gives consistent relief from pain with improved shoulder movement in patients with symptomatic massive tears of the rotator cuff


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 1 | Pages 92 - 97
1 Jan 2010
Kulkarni GS Kulkarni VS Shyam AK Kulkarni RM Kulkarni MG Nayak P

Arthrolysis and dynamic splinting have been used in the treatment of elbow contractures, but there is no standardised protocol for treatment of severe contractures with an arc of flexion < 30°. We present our results of radical arthrolysis with twin incisions with the use of a monolateral hinged fixator to treat very severe extra-articular contracture of the elbow. This retrospective study included 26 patients (15 males and 11 females) with a mean age of 30 years (12 to 60). The mean duration of stiffness was 9.1 months (5.4 to 18) with mean follow-up of 5.2 years (3.5 to 9.4). The mean pre-operative arc of movement was 15.6° (0° to 30°), with mean pre-operative flexion of 64.1° (30° to 120°) and mean pre-operative extension of 52.1° (10° to 90°). Post-operatively the mean arc improved to 102.4° (60° to 135°), the mean flexion improved to 119.1° (90° to 140°) and mean extension improved to 16.8° (0° to 30°) (p < 0.001). The Mayo elbow score improved from a mean of 45 (30 to 65) to 89 (75 to 100) points, and 13 had excellent, nine had good, three had fair and one had a poor result. We had one case of severe instability and one wound dehiscence which responded well to treatment. One case had deep infection with poor results which responded well to treatment. Our findings indicate that this method is very effective in the treatment of severe elbow contracture; however, a randomised controlled study is necessary for further evaluation