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Bone & Joint Research
Vol. 13, Issue 4 | Pages 169 - 183
15 Apr 2024
Gil-Melgosa L Llombart-Blanco R Extramiana L Lacave I Abizanda G Miranda E Agirre X Prósper F Pineda-Lucena A Pons-Villanueva J Pérez-Ruiz A

Aims

Rotator cuff (RC) injuries are characterized by tendon rupture, muscle atrophy, retraction, and fatty infiltration, which increase injury severity and jeopardize adequate tendon repair. Epigenetic drugs, such as histone deacetylase inhibitors (HDACis), possess the capacity to redefine the molecular signature of cells, and they may have the potential to inhibit the transformation of the fibro-adipogenic progenitors (FAPs) within the skeletal muscle into adipocyte-like cells, concurrently enhancing the myogenic potential of the satellite cells.

Methods

HDACis were added to FAPs and satellite cell cultures isolated from mice. The HDACi vorinostat was additionally administered into a RC injury animal model. Histological analysis was carried out on the isolated supra- and infraspinatus muscles to assess vorinostat anti-muscle degeneration potential.


Bone & Joint Research
Vol. 12, Issue 3 | Pages 165 - 177
1 Mar 2023
Boyer P Burns D Whyne C

Aims

An objective technological solution for tracking adherence to at-home shoulder physiotherapy is important for improving patient engagement and rehabilitation outcomes, but remains a significant challenge. The aim of this research was to evaluate performance of machine-learning (ML) methodologies for detecting and classifying inertial data collected during in-clinic and at-home shoulder physiotherapy exercise.

Methods

A smartwatch was used to collect inertial data from 42 patients performing shoulder physiotherapy exercises for rotator cuff injuries in both in-clinic and at-home settings. A two-stage ML approach was used to detect out-of-distribution (OOD) data (to remove non-exercise data) and subsequently for classification of exercises. We evaluated the performance impact of grouping exercises by motion type, inclusion of non-exercise data for algorithm training, and a patient-specific approach to exercise classification. Algorithm performance was evaluated using both in-clinic and at-home data.


Bone & Joint Research
Vol. 5, Issue 5 | Pages 175 - 177
1 May 2016
Rubin G Rinott M Wolovelsky A Rosenberg L Shoham Y Rozen N

Objectives

Injectable Bromelain Solution (IBS) is a modified investigational derivate of the medical grade bromelain-debriding pharmaceutical agent (NexoBrid) studied and approved for a rapid (four-hour single application), eschar-specific, deep burn debridement. We conducted an ex vivo study to determine the ability of IBS to dissolve-disrupt (enzymatic fasciotomy) Dupuytren’s cords.

Materials and Methods

Specially prepared medical grade IBS was injected into fresh Dupuytren’s cords excised from patients undergoing surgical fasciectomy. These cords were tested by tension-loading them to failure with the Zwick 1445 (Zwick GmbH & Co. KG, Ulm, Germany) tension testing system.


The Bone & Joint Journal
Vol. 95-B, Issue 6 | Pages 809 - 814
1 Jun 2013
Park HY Yoon JO Jeon IH Chung HW Kim JS

This study was performed to determine whether pure cancellous bone graft and Kirschner (K-) wire fixation were sufficient to achieve bony union and restore alignment in scaphoid nonunion. A total of 65 patients who underwent cancellous bone graft and K-wire fixation were included in this study. The series included 61 men and four women with a mean age of 34 years (15 to 72) and mean delay to surgery of 28.7 months (3 to 240). The patients were divided into an unstable group (A) and stable group (B) depending on the pre-operative radiographs. Unstable nonunion was defined as a lateral intrascaphoid angle > 45°, or a radiolunate angle > 10°. There were 34 cases in group A and 31 cases in group B. Bony union was achieved in 30 patients (88.2%) in group A, and in 26 (83.9%) in group B (p = 0.439). Comparison of the post-operative radiographs between the two groups showed no significant differences in lateral intrascaphoid angle (p = 0.657) and scaphoid length (p = 0.670) and height (p = 0.193). The radiolunate angle was significantly different (p = 0.020) but the mean value in both groups was < 10°. Comparison of the dorsiflexion and palmar flexion of movement of the wrist and the mean Mayo wrist score at the final clinical visit in each group showed no significant difference (p = 0.190, p = 0.587 and p = 0.265, respectively). Cancellous bone graft and K-wire fixation were effective in the treatment of stable and unstable scaphoid nonunion.

Cite this article: Bone Joint J 2013;95-B:809–14.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 12 | Pages 1660 - 1665
1 Dec 2012
Megerle K Bertel D Germann G Lehnhardt M Hellmich S

The purpose of this study was to assess the clinical and radiological outcomes of dorsal intercarpal ligament capsulodesis for the treatment of static scapholunate instability at a minimum follow-up of four years. A total of 59 patients who underwent capsulodesis for this condition were included in a retrospective analysis after a mean of 8.25 years (4.3 to 12). A total of eight patients underwent a salvage procedure at a mean of 2.33 years (0.67 to 7.6) and were excluded. The mean range of extension/flexion was 88° (15° to 135°) and of ulnar/radial deviation was 38° (0° to 75°) at final follow-up. The mean Disabilities of the Arm Shoulder and Hand (DASH) score and Mayo wrist scores were 28 (0 to 85) and 61 (0 to 90), respectively. After significant improvement immediately post-operatively (p < 0.001 and p = 0.001, respectively), the mean scapholunate and radiolunate angles deteriorated to 70° (40° to 90°) and 8° (-15° to 25°), respectively, at final follow-up, which were not significantly different from their pre-operative values (p = 0.6 and p = 0.4, respectively). The mean carpal height index decreased significantly from 1.53 (1.38 to 1.65) to 1.48 (1.29 to 1.65) indicating progressive carpal collapse (p < 0.001); 40 patients (78%) had radiological evidence of degenerative arthritis.

Capsulodesis did not maintain carpal reduction over time. Although the consequent ongoing scapholunate instability resulted in early arthritic degeneration, most patients had acceptable long-term function of the wrist.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 11 | Pages 1540 - 1545
1 Nov 2012
Reigstad O Lütken T Grimsgaard C Bolstad B Thorkildsen R Røkkum M

The Motec cementless modular metal-on-metal ball-and-socket wrist arthroplasty was implanted in 16 wrists with scaphoid nonunion advanced collapse (SNAC; grades 3 or 4) and 14 wrists with scapholunate advanced collapse (SLAC) in 30 patients (20 men) with severe (grades 3 or 4) post-traumatic osteoarthritis of the wrist. The mean age of the patients was 52 years (31 to 71). All prostheses integrated well radiologically. At a mean follow-up of 3.2 years (1.1 to 6.1) no luxation or implant breakage occurred. Two wrists were converted to an arthrodesis for persistent pain. Loosening occurred in one further wrist at five years post-operatively. The remainder demonstrated close bone–implant contact. The clinical results were good, with markedly decreased Disabilities of the Arm Shoulder and Hand (DASH) and pain scores, and increased movement and grip strength. No patient used analgesics and most had returned to work.

Good short-term function was achieved using this wrist arthroplasty in a high-demand group of patients with post-traumatic osteoarthritis.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 11 | Pages 1448 - 1454
1 Nov 2012
Ng CY Watts AC

Bone loss involving articular surface is a challenging problem faced by the orthopaedic surgeon. In the hand and wrist, there are articular defects that are amenable to autograft reconstruction when primary fixation is not possible. In this article, the surgical techniques and clinical outcomes of articular reconstructions in the hand and wrist using non-vascularised osteochondral autografts are reviewed.


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 Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 9 | Pages 1253 - 1259
1 Sep 2012
Sewell MD Higgs DS Al-Hadithy N Falworth M Bayley I Lambert SM

Scapulothoracic fusion (STF) for painful winging of the scapula in neuromuscular disorders can provide effective pain relief and functional improvement, but there is little information comparing outcomes between patients with dystrophic and non-dystrophic conditions. We performed a retrospective review of 42 STFs in 34 patients with dystrophic and non-dystrophic conditions using a multifilament trans-scapular, subcostal cable technique supported by a dorsal one-third semi-tubular plate. There were 16 males and 18 females with a mean age of 30 years (15 to 75) and a mean follow-up of 5.0 years (2.0 to 10.6). The mean Oxford shoulder score improved from 20 (4 to 39) to 31 (4 to 48). Patients with non-dystrophic conditions had lower overall functional scores but achieved greater improvements following STF. The mean active forward elevation increased from 59° (20° to 90°) to 97° (30° to 150°), and abduction from 51° (10° to 90°) to 83° (30° to 130°) with a greater range of movement achieved in the dystrophic group. Revision fusion for nonunion was undertaken in five patients at a mean time of 17 months (7 to 31) and two required revision for fracture. There were three pneumothoraces, two rib fractures, three pleural effusions and six nonunions. The main risk factors for nonunion were smoking, age and previous shoulder girdle surgery.

STF is a salvage procedure that can provide good patient satisfaction in 82% of patients with both dystrophic and non-dystrophic pathologies, but there was a relatively high failure rate (26%) when poor outcomes were analysed. Overall function was better in patients with dystrophic conditions which correlated with better range of movement; however, patients with non-dystrophic conditions achieved greater functional improvement.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 8 | Pages 1090 - 1096
1 Aug 2012
Mahmoud M El Shafie S Kamal M

Malunion is the most common complication of the distal radius with many modalities of treatment available for such a problem. The use of bone grafting after an osteotomy is still recommended by most authors. We hypothesised that bone grafting is not required; fixing the corrected construct with a volar locked plate helps maintain the alignment, while metaphyseal defect fills by itself. Prospectively, we performed the procedure on 30 malunited dorsally-angulated radii using fixed angle volar locked plates without bone grafting. At the final follow-up, 22 wrists were available. Radiological evidence of union, correction of the deformity, clinical and functional improvement was achieved in all cases. Without the use of bone grafting, corrective open wedge osteotomy fixed by a volar locked plate provides a high rate of union and satisfactory functional outcomes.


Bone & Joint Research
Vol. 1, Issue 7 | Pages 158 - 166
1 Jul 2012
Dean BJF Franklin SL Carr AJ

Introduction

The pathogenesis of rotator cuff disease (RCD) is complex and not fully understood. This systematic review set out to summarise the histological and molecular changes that occur throughout the spectrum of RCD.

Methods

We conducted a systematic review of the scientific literature with specific inclusion and exclusion criteria.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 6 | Pages 805 - 810
1 Jun 2012
Flinkkilä T Kaisto T Sirniö K Hyvönen P Leppilahti J

We assessed the short- to mid-term survival of metallic press-fit radial head prostheses in patients with radial head fractures and acute traumatic instability of the elbow. The medical records of 42 patients (16 males, 26 females) with a mean age of 56 years (23 to 85) with acute unstable elbow injuries, including a fracture of the radial head requiring metallic replacement of the radial head, were reviewed retrospectively. Survival of the prosthesis was assessed from the radiographs of 37 patients after a mean follow-up of 50 months (12 to 107). The functional results of 31 patients were assessed using range-of-movement, Mayo elbow performance score (MEPS), Disabilities of the Arm, Shoulder and Hand (DASH) score and the RAND 36-item health survey. At the most recent follow-up 25 prostheses were still well fixed, nine had been removed because of loosening, and three remained implanted but were loose. The mean time from implantation to loosening was 11 months (2 to 24). Radiolucent lines that developed around the prosthesis before removal were mild in three patients, moderate in one and severe in five. Range of movement parameters and mass grip strength were significantly lower in the affected elbow than in the unaffected side. The mean MEPS score was 86 (40 to 100) and the mean DASH score was 23 (0 to 81). According to RAND-36 scores, patients had more pain and lower physical function scores than normal population values. Loosening of press-fit radial head prostheses is common, occurs early, often leads to severe osteolysis of the proximal radius, and commonly requires removal of the prosthesis


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 1 | Pages 80 - 85
1 Jan 2012
Malone AA Sanchez JS Adams R Morrey B

We report the effectiveness of revision of total elbow replacement by re-cementing. Between 1982 and 2004, 53 elbows in 52 patients were treated with re-cementing of a total elbow replacement into part or all of the existing cement mantle or into the debrided host-bone interface, without the use of structural bone augmentation or a custom prosthesis. The original implant revision was still in situ and functional in 42 of 53 elbows (79%) at a mean of 94.5 months (26 to 266) after surgery. In 31 of these 42 elbows (74%) the Mayo Elbow Performance Score was good or excellent. Overall, of the 53 elbows, 18 (34%) required re-operation, ten (19%) for loosening. A classification system was developed to identify those not suitable for revision by this technique, and using this we have showed that successful re-implantation is statistically correlated to properly addressing the bone deficiency for both the humeral (p = 0.005) and the ulnar (p = 0.039) components.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 1 | Pages 86 - 92
1 Jan 2012
Jeon IH Sanchez-Sotelo J Zhao K An KN Morrey BM

We undertook this study to determine the minimum amount of coronoid necessary to stabilise an otherwise intact elbow joint. Regan–Morrey types II and III, plus medial and lateral oblique coronoid fractures, collectively termed type IV fractures, were simulated in nine fresh cadavers. An electromagnetic tracking system defined the three-dimensional stability of the ulna relative to the humerus. The coronoid surface area accounts for 59% of the anterior articulation. Alteration in valgus, internal and external rotation occurred only with a type III coronoid fracture, accounting for 68% of the coronoid and 40% of the entire articular surface. A type II fracture removed 42% of the coronoid articulation and 25% of the entire articular surface but was associated with valgus and external rotational changes only when the radial head was removed, thereby removing 67% of the articular surface.

We conclude that all type III fractures, as defined here, are unstable, even with intact ligaments and a radial head. However, a type II deficiency is stable unless the radial head is removed. Our study suggests that isolated medial-oblique or lateral-oblique fractures, and even a type II fracture with intact ligaments and a functional radial head, can be clinically stable, which is consistent with clinical observation.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 9 | Pages 1240 - 1246
1 Sep 2011
Melis B DeFranco M Lädermann A Molé D Favard L Nérot C Maynou C Walch G

Radiological changes and differences between cemented and uncemented components of Grammont reverse shoulder arthroplasties (DePuy) were analysed at a mean follow-up of 9.6 years (8 to 12). Of 122 reverse shoulder arthroplasties implanted in five shoulder centres between 1993 and 2000, a total of 68 (65 patients) were available for study. The indications for reversed shoulder arthroplasty were cuff tear arthropathy in 48 shoulders, revision of shoulder prostheses of various types in 11 and massive cuff tear in nine. The development of scapular notching, bony scapular spur formation, heterotopic ossification, glenoid and humeral radiolucencies, stem subsidence, radiological signs of stress shielding and resorption of the tuberosities were assessed on standardised true anteroposterior and axillary radiographs.

A scapular notch was observed in 60 shoulders (88%) and was associated with the superolateral approach (p = 0.009). Glenoid radiolucency was present in 11 (16%), bony scapular spur and/or ossifications in 51 (75%), and subsidence of the stem and humeral radiolucency in more than three zones were present in three (8.8%) and in four (11.8%) of 34 cemented components, respectively, and in one (2.9%) and two (5.9%) of 34 uncemented components, respectively. Radiological signs of stress shielding were significantly more frequent with uncemented components (p < 0.001), as was resorption of the greater (p < 0.001) and lesser tuberosities (p = 0.009).


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 7 | Pages 932 - 936
1 Jul 2011
Mahmoud M Koptan W

Ununited fractures of the scaphoid with extensive bone resorption are usually treated by bone grafting and internal fixation, using either an open or a minimally invasive technique. We studied the feasibility of percutaneous fixation without bone grafting in a consecutive series of 27 patients with established nonunion of an undisplaced fracture of the scaphoid and extensive local resorption of bone. They were treated by a single surgeon with rigid fixation alone, using a headless cannulated screw inserted through a volar percutaneous technique. Clinical examination, standard radiographs and CT confirmed that the fracture had united in all patients at a mean of 11.6 weeks (8 to 16), and that their functional scores had improved.

We concluded that extensive resorption at the fracture site is not an absolute indication for bone grafting, and that percutaneous fixation alone will eventually produce healing of ununited undisplaced fractures of the scaphoid regardless of the size of the gap.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 3 | Pages 364 - 369
1 Mar 2011
Suzuki O Sunagawa T Yokota K Nakashima Y Shinomiya R Nakanishi K Ochi M

The transfer of part of the ulnar nerve to the musculocutaneous nerve, first described by Oberlin, can restore flexion of the elbow following brachial plexus injury. In this study we evaluated the additional benefits and effectiveness of quantitative electrodiagnosis to select a donor fascicle. Eight patients who had undergone transfer of a simple fascicle of the ulnar nerve to the motor branch of the musculocutaneous nerve were evaluated. In two early patients electrodiagnosis had not been used. In the remaining six patients, however, all fascicles of the ulnar nerve were separated and electrodiagnosis was performed after stimulation with a commercially available electromyographic system. In these procedures, recording electrodes were placed in flexor carpi ulnaris and the first dorsal interosseous. A single fascicle in the flexor carpi ulnaris in which a high amplitude had been recorded was selected as a donor and transferred to the musculocutaneous nerve. In the two patients who had not undergone electrodiagnosis, the recovery of biceps proved insufficient for normal use. Conversely, in the six patients in whom quantitative electrodiagnosis was used, elbow flexion recovered to an M4 level.

Quantitative intra-operative electrodiagnosis is an effective method of selecting a favourable donor fascicle during the Oberlin procedure. Moreover, fascicles showing a high-amplitude in reading flexor carpi ulnaris are donor nerves that can restore normal elbow flexion without intrinsic loss.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 2 | Pages 223 - 228
1 Feb 2011
Neumann M Nyffeler R Beck M

Mason type III fractures of the radial head are treated by open reduction and internal fixation, resection or prosthetic joint replacement. When internal fixation is performed, fixation of the radial head to the shaft is difficult and implant-related complications are common. Furthermore, problems of devascularisation of the radial head can result from fixation of the plate to the radial neck. In a small retrospective study, the treatment of Mason type III fractures with fixation of the radial neck in 13 cases (group 2) was compared with 12 cases where no fixation was performed (group 1). The mean clinical and radiological follow-up was four years (1 to 9). The Broberg-Morrey index showed excellent results in both groups. Degenerative radiological changes were seen more frequently in group 2, and removal of the implant was necessary in seven of 13 cases. Post-operative evaluation of these two different techniques revealed similar ranges of movement and functional scores. We propose that anatomical reconstruction of the radial head without metalwork fixation to the neck is preferable, and the outcome is the same as that achieved with the conventional technique. In addition degenerative changes of the elbow joint may develop less frequently, and implant removal is not necessary


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 2 | Pages 210 - 216
1 Feb 2011
Young A Walch G Boileau P Favard L Gohlke F Loew M Molé D

We report the long-term clinical and radiological outcomes of the Aequalis total shoulder replacement with a cemented all-polyethylene flat-back keeled glenoid component implanted for primary osteoarthritis between 1991 and 2003 in nine European centres. A total of 226 shoulders in 210 patients were retrospectively reviewed at a mean of 122.7 months (61 to 219) or at revision. Clinical outcome was assessed using the Constant score, patient satisfaction score and range of movement. Kaplan-Meier survivorship analysis was performed with glenoid revision for loosening and radiological glenoid loosening (sd) as endpoints. The Constant score was found to improve from a mean of 26.8 (sd 10.3) pre-operatively to 57.6 (sd 20.0) post-operatively (p < 0.001). Active forward flexion improved from a mean of 85.3° (sd 27.4) pre-operatively to 125° (sd 37.3) postoperatively (p < 0.001). External rotation improved from a mean of 7° (sd 6.5) pre-operatively to 30.3° (sd 21.8°) post-operatively (p < 0.001). Survivorship with revision of the glenoid component as the endpoint was 99.1% at five years, 94.5% at ten years and 79.4% at 15 years. Survivorship with radiological loosening as the endpoint was 99.1% at five years, 80.3% at ten years and 33.6% at 15 years.

Younger patient age and the curettage technique for glenoid preparation correlated with loosening. The rate of glenoid revision and radiological loosening increased with duration of follow-up, but not until a follow-up of five years. Therefore, we recommend that future studies reporting radiological outcomes of new glenoid designs should report follow-up of at least five to ten years.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 1 | Pages 57 - 61
1 Jan 2011
Naveed MA Kitson J Bunker TD

The combination of an irreparable tear of the rotator cuff and destructive arthritis of the shoulder joint may cause severe pain, disability and loss of independence in the aged. Standard anatomical shoulder replacements depend on a functioning rotator cuff, and hence may fail in the presence of tears in the cuff. Many designs of non-anatomical constrained or semi-constrained prostheses have been developed for cuff tear arthropathy, but have proved unsatisfactory and were abandoned. The DePuy Delta III reverse prosthesis, designed by Grammont, medialises and stabilises the centre of rotation of the shoulder joint and has shown early promise. This study evaluated the mid-term clinical and radiological results of this arthroplasty in a consecutive series of 50 shoulders in 43 patients with a painful pseudoparalysis due to an irreparable cuff tear and destructive arthritis, performed over a period of seven years by a single surgeon. A follow-up of 98% was achieved, with a mean duration of 39 months (8 to 81). The mean age of the patients at the time of surgery was 81 years (59 to 95). The female to male ratio was 5:1. During the seven years, six patients died of natural causes. The clinical outcome was assessed using the American Shoulder and Elbow score, the Oxford Shoulder Score and the Short-form 36 score. A radiological review was performed using the Sirveaux score for scapular notching.

The mean American Shoulder and Elbow score was 19 (95% confidence interval (CI) 14 to 23) pre-operatively, and 65 (95% CI 48 to 82) (paired t-test, p < 0.001) at final follow-up. The mean Oxford score was 44 (95% CI 40 to 51) pre-operatively and 23 (95% CI 18 to 28) (paired t-test, p < 0.001) at final follow-up.

The mean maximum elevation improved from 55° pre-operatively to 105° at final follow-up. There were seven complications during the whole series, although only four patients required further surgery.