We present a review of claims made to the NHS Litigation Authority (NHSLA) by patients with conditions affecting the shoulder and elbow, and identify areas of dissatisfaction and potential improvement. Between 1995 and 2012, the NHSLA recorded 811 claims related to the shoulder and elbow, 581 of which were settled. This comprised 364 shoulder (64%), and 217 elbow (36%) claims. A total of £18.2 million was paid out in settled claims. Overall diagnosis, mismanagement and intra-operative nerve injury were the most common reasons for litigation. The highest cost paid out resulted from claims dealing with incorrect, missed or delayed diagnosis, with just under £6 million paid out overall. Fractures and dislocations around the shoulder and elbow were common injuries in this category. All 11 claims following wrong-site surgery that were settled led to successful payouts. This study highlights the diagnoses and procedures that need to be treated with particular vigilance. Having an awareness of the areas that lead to litigation in shoulder and elbow surgery will help to reduce inadvertent risks to patients and prevent dissatisfaction and possible litigation. . Cite this article: Bone Joint J 2014; 96-B:574–9

Dislocation of the shoulder may occur during seizures in epileptics and other patients who have convulsions. Following the initial injury, recurrent instability is common owing to a tendency to develop large bony abnormalities of the humeral head and glenoid and a susceptibility to further seizures. Assessment is difficult and diagnosis may be missed, resulting in chronic locked dislocations with protracted morbidity. Many patients have medical comorbidities, and successful treatment requires a multidisciplinary approach addressing the underlying seizure disorder in addition to the shoulder pathology. The use of bony augmentation procedures may have improved the outcomes after surgical intervention, but currently there is no evidence-based consensus to guide treatment. This review outlines the epidemiology and pathoanatomy of seizure-related instability, summarising the currently-favoured options for treatment, and their results

A total of 12 epileptic patients (14 shoulders) with recurrent seizures and anterior dislocations of the shoulder underwent a Latarjet procedure and were reviewed at a mean of 8.3 years (1 to 20) post-operatively. Mean forward flexion decreased from 165° (100° to 180°) to 160° (90° to 180°) (p = 0.5) and mean external rotation from 54° (10° to 90°) to 43° (5° to 75°) (p = 0.058). The mean Rowe score was 76 (35 to 100) at the final follow-up. Radiologically, all shoulders showed a glenoid-rim defect and Hill-Sachs lesions pre-operatively. Osteo-arthritic changes of the glenohumeral joint were observed in five shoulders (36%) pre-operatively and in eight shoulders (57%) post-operatively. Re-dislocation during a seizure occurred in six shoulders (43%). Five of these patients underwent revision surgery using a bone buttress from the iliac crest and two of these patients re-dislocated due to a new seizure. . Due to the unacceptably high rate of re-dislocation after surgery in these patients, the most important means of reducing the incidence of further dislocation is the medical management of the seizures. The Latarjet procedure should be reserved for the well-controlled patient with epilepsy who has recurrent anterior dislocation of the shoulder during activities of daily living

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

A total of 92 patients with symptoms for over six months due to subacromial impingement of the shoulder, who were being treated with physiotherapy, were included in this study. While continuing with physiotherapy they waited a further six months for surgery. They were divided into three groups based on the following four clinical and radiological criteria: temporary benefit following steroid injection, pain in the mid-arc of abduction, a consistently positive Hawkins test and radiological evidence of impingement. Group A fulfilled all four criteria, group B three criteria and group C two criteria. A total of nine patients improved while waiting for surgery and were excluded, leaving 83 who underwent arthroscopic subacromial decompression (SAD). The new Oxford shoulder score was recorded pre-operatively and at three and 12 months post-operatively. A total of 51 patients (group A) had a significant improvement in the mean shoulder score from 18 (13 to 22) pre-operatively to 38 (35 to 42) at three months (p < 0.001). The mean score in this group was significantly better than in group B (21 patients) and C (11 patients) at this time. At one year patients in all groups showed improvement in scores, but patients in group A had a higher mean score (p = 0.01). At one year patients in groups A and B did better than those in group C (p = 0.01). Arthroscopic SAD is a beneficial intervention in selected patients. The four criteria could help identify patients in whom it is likely to be most effective

Objectives. Cadaveric models of the shoulder evaluate discrete motion segments using the glenohumeral joint in isolation over a defined trajectory. The aim of this study was to design, manufacture and validate a robotic system to accurately create three-dimensional movement of the upper body and capture it using high-speed motion cameras. Methods. In particular, we intended to use the robotic system to simulate the normal throwing motion in an intact cadaver. The robotic system consists of a lower frame (to move the torso) and an upper frame (to move an arm) using seven actuators. The actuators accurately reproduced planned trajectories. The marker setup used for motion capture was able to determine the six degrees of freedom of all involved joints during the planned motion of the end effector. Results. The testing system demonstrated high precision and accuracy based on the expected versus observed displacements of individual axes. The maximum coefficient of variation for displacement of unloaded axes was less than 0.5% for all axes. The expected and observed actual displacements had a high level of correlation with coefficients of determination of 1.0 for all axes. Conclusions. Given that this system can accurately simulate and track simple and complex motion, there is a new opportunity to study kinematics of the shoulder under normal and pathological conditions in a cadaveric shoulder model

In adults with brachial plexus injuries, lack of active external rotation at the shoulder is one of the most common residual deficits, significantly compromising upper limb function. There is a paucity of evidence to address this complex issue. We present our experience of isolated latissimus dorsi (LD) muscle transfer to achieve active external rotation. This is a retrospective review of 24 adult post-traumatic plexopathy patients who underwent isolated latissimus dorsi muscle transfer to restore external rotation of the shoulder between 1997 and 2010. All patients were male with a mean age of 34 years (21 to 57). All the patients underwent isolated LD muscle transfer using a standard technique to correct external rotational deficit. Outcome was assessed for improvement in active external rotation, arc of movement, muscle strength and return to work. The mean improvement in active external rotation from neutral was 24° (10° to 50°). The mean increase in arc of rotation was 52° (38° to 55°). Mean power of the external rotators was 3.5 Medical Research Council (MRC) grades (2 to 5). A total of 21 patients (88%) were back in work by the time of last follow up. Of these, 13 had returned to their pre-injury occupation. Isolated latissimus dorsi muscle transfer provides a simple and reliable method of restoring useful active external rotation in adults with brachial plexus injuries with internal rotational deformity. Cite this article: Bone Joint J 2013;95-B:660–3

We have investigated the outcome of arthroscopic revision surgery for recurrent instability of the shoulder after failed primary anterior stabilisation. We identified 40 patients with failed primary open or arthroscopic anterior stabilisation of the shoulder who had been treated by revision arthroscopic capsulolabral reconstruction and followed up for a mean of 36 months (12 to 87). There were 34 men and six women with a mean age of 33.1 years (15 to 48). Details of the patients, the technique of the primary procedure, the operative findings at revision and the clinical outcome were evaluated by reviewing the medical records, physical examination and the use of the Western Ontario shoulder instability index score, the American Shoulder and Elbow Surgeons score and the health status questionnaire 12. Recurrent instability persisted in four patients after the revision arthroscopic procedure. At the final follow-up, the mean American Shoulder and Elbow Surgeons score was 81.1 (17.5 to 99.5) and the mean Western Ontario shoulder instability index score was 68.2 (20 to 98.2). Quality-of-life scoring showed good to excellent results in most patients. Arthroscopic revision capsulolabral reconstruction can provide a satisfactory outcome in selected patients for recurrent instability of the shoulder provided that no large Hill-Sachs lesion is present

Antegrade intramedullary nailing of fractures of the shaft of the humerus is reported to cause impairment of the shoulder joint. We have reviewed 33 patients with such fractures to assess how many had injuries to the ipsilateral shoulder. All had an MR scan of the shoulder within 11 days of injury. The unaffected shoulder was also scanned as a control. There was evidence of abnormality in 21 of the shoulders (63.6%) on the injured side; ten had bursitis of the subacromial space, five evidence of a partial tear of the rotator cuff, one a complete rupture of the supraspinatus tendon, four inflammatory changes in the acromioclavicular joint and one a fracture of the coracoid process. These injuries may contribute to pain and dysfunction of the shoulder following treatment, and their presence indicates that antegrade nailing is only partly, if at all, responsible for these symptoms

There is little published information on the health impact of frozen shoulder. The purpose of this study was to assess the functional and health-related quality of life outcomes following arthroscopic capsular release (ACR) for contracture of the shoulder. Between January 2010 and January 2012 all patients who had failed non-operative treatment including anti-inflammatory medication, physiotherapy and glenohumeral joint injections for contracture of the shoulder and who subsequently underwent an ACR were enrolled in the study. A total of 100 patients were eligible; 68 underwent ACR alone and 32 had ACR with a subacromial decompression (ASD). ACR resulted in a highly significant improvement in the range of movement and functional outcome, as measured by the Oxford shoulder score and EuroQol EQ-5D index. The mean cost of a quality-adjusted life year (QALY) for an ACR and ACR with an ASD was £2563 and £3189, respectively. . ACR is thus a cost-effective procedure that can restore relatively normal function and health-related quality of life in most patients with a contracture of the shoulder within six months after surgery; and the beneficial effects are not related to the duration of the presenting symptoms. Cite this article: Bone Joint J 2013;95-B:942–6

We have examined the relief from pain and the functional outcome in 18 patients who underwent resection arthroplasty of the shoulder as a salvage operation between 1988 and 2002. The indications included failed shoulder replacement in 17, with infection in 13, and chronic septic arthritis in one. The mean follow-up was 8.3 years (2.5 to 16.6). Two intra-operative fractures of the humerus occurred, both of which healed. The level of pain was significantly decreased (t-test, p < 0.001) but five patients continued to have moderate to severe pain. The mean active elevation was 70° (0° to 150°) postoperatively and represented an improvement from 39° (0° to 140°) (t-test, p = 0.003), but internal and external rotation were hardly changed. The mean number of positive answers on the 12-question Simple Shoulder Test was 3.1 (0 to 12) but the shoulder was generally comfortable when the arm was positioned at rest by the side. The mean post-operative American Shoulder and Elbow Surgeon’s score was 36 (8 to 73). Despite applying this procedure principally to failed shoulder replacements, the results were similar to those reported in the literature for patients after severe fracture-dislocation. Reduction of pain is possible in one half to two-thirds of patients. The outcome of this operation in providing relief from pain cannot be guaranteed, but the shoulder is usually comfortable at rest, albeit with profound functional limitations

We describe the outcome at a mean follow-up of 8.75 years (7.6 to 9.8) of seven patients who had undergone osteochondral autologous transplantation for full-thickness cartilage defects of the shoulder between 1998 and 2000. These patients have been described previously at a mean of 32.6 months when eight were included. One patient has been lost to follow-up. The outcome was assessed by the Constant shoulder score and the Lysholm knee score to assess any donor-site morbidity. Standard radiographs and MR scores were obtained and compared with the pre-operative findings and the results from the previous review. No patient required any further surgery on the shoulder. The mean Constant score improved significantly until the final follow-up (p = 0.018). The Lysholm score remained excellent throughout. There was a significant progression of osteoarthritic changes from the initial surgery to the first and final follow-up but this did not appear to be related to the size of the defect, the number of cylinders required or the Constant score (p = 0.016). MRI showed that all except one patient had a congruent joint surface at the defect with full bony integration of all osteochondral cylinders. The results have remained satisfactory over a longer period with very good objective and subjective findings

The treatment of a chronic posterior dislocation of the shoulder is often determined by the size of the associated impression fracture of the humeral head. Our hypothesis was that patients with a chronic unreduced posterior dislocation of the shoulder and a defect in the humeral head involving between 25% to 50% of the articular surface, would do better if reconstructed with an allograft from the femoral head rather than treated by a non-anatomical reconstruction. We reviewed ten men and three women with a mean age of 42 years (36 to 51) at a mean follow-up of 54 months (41 to 64) who had this procedure. At follow-up, nine had no pain or restriction of activities of daily living. Their mean Constant-Murley shoulder score was 86.8 (43 to 98). No patient had symptoms of instability of the shoulder. Reconstruction of the defect in the humeral head with an allograft provides good pain relief, stability and function for patients with a locked, chronic posterior dislocation where the defect involves between 25% and 50% of the circumference of the articular surface

We report the use of the reverse shoulder prosthesis in the revision of a failed shoulder hemiarthroplasty in 19 shoulders in 18 patients (7 men, 11 women) with severe pain and loss of function. The primary procedure had been undertaken for glenohumeral arthritis associated with severe rotator cuff deficiency. Statistically significant improvements were seen in pain and functional outcome. After a mean follow-up of 44 months (24 to 89), mean forward flexion improved by 26.4° and mean abduction improved by 35°. There were six prosthesis-related complications in six shoulders (32%), five of which had severe bone loss of the glenoid, proximal humerus or both. Three shoulders (16%) had non-prosthesis related complications. The use of the reverse shoulder prosthesis provides improvement in pain and function for patients with failure of a hemiarthroplasty for glenohumeral arthritis and rotator cuff deficiency. However, high rates of complications were associated with glenoid and proximal humeral bone loss

We undertook a prospective study in 51 male patients aged between 17 and 27 years to ascertain whether immobilisation after primary traumatic anterior dislocation of the shoulder in external rotation was more effective than immobilisation in internal rotation in preventing recurrent dislocation in a physically active population. Of the 51 patients, 24 were randomised to be treated by a traditional brace in internal rotation and 27 were immobilised in external rotation of 15° to 20°. After immobilisation, the patients undertook a standard regime of physiotherapy and were then assessed clinically for evidence of instability. When reviewed at a mean of 33.4 months (24 to 48) ten from the external rotation group (37%) and ten from the internal rotation group (41.7%) had sustained a futher dislocation. There was no statistically significant difference (p = 0.74) between the groups. Our findings show that external rotation bracing may not be as effective as previously reported in preventing recurrent anterior dislocation of the shoulder

Impingement syndrome in the shoulder has generally been considered to be a clinical condition of mechanical origin. However, anomalies exist between the pathology in the subacromial space and the degree of pain experienced. These may be explained by variations in the processing of nociceptive inputs between different patients. We investigated the evidence for augmented pain transmission (central sensitisation) in patients with impingement, and the relationship between pre-operative central sensitisation and the outcomes following arthroscopic subacromial decompression. We recruited 17 patients with unilateral impingement of the shoulder and 17 age- and gender-matched controls, all of whom underwent quantitative sensory testing to detect thresholds for mechanical stimuli, distinctions between sharp and blunt punctate stimuli, and heat pain. Additionally Oxford shoulder scores to assess pain and function, and PainDETECT questionnaires to identify ‘neuropathic’ and referred symptoms were completed. Patients completed these questionnaires pre-operatively and three months post-operatively. A significant proportion of patients awaiting subacromial decompression had referred pain radiating down the arm and had significant hyperalgesia to punctate stimulus of the skin compared with controls (unpaired t-test, p < 0.0001). These are felt to represent peripheral manifestations of augmented central pain processing (central sensitisation). The presence of either hyperalgesia or referred pain pre-operatively resulted in a significantly worse outcome from decompression three months after surgery (unpaired t-test, p = 0.04 and p = 0.005, respectively). These observations confirm the presence of central sensitisation in a proportion of patients with shoulder pain associated with impingement. Also, if patients had relatively high levels of central sensitisation pre-operatively, as indicated by higher levels of punctate hyperalgesia and/or referred pain, the outcome three months after subacromial decompression was significantly worse

We carried out a prospective, randomised controlled trial on two groups of 40 patients with painful calcific tendonitis and a mean age of 48.4 years (32.5 to 67.3). All were to undergo arthroscopic removal of the calcific deposit within six months after randomisation. The 40 patients in group I received ultrasound-guided needling followed by high-energy shock-wave therapy and the 40 in group II had shock-wave therapy alone. In both groups one treatment consisting of 2500 impulses of shock waves with an energy flux density of 0.36 mJ/mm. 2. was applied. The clinical and radiological outcome was assessed using the 100-point Constant shoulder scoring system and standardised radiographs. The mean follow-up was 4.1 months and no patient was lost to follow-up. Both groups had significant improvement in their Constant shoulder score. Radiographs showed disappearance of the calcific deposit in 60.0% of the shoulders in group I and in 32.5% of group II (p < 0.05). Significantly better clinical and radiological results were obtained in group I than in group II. Arthroscopic removal of the deposit was avoided in 32 patients of group I and in 22 of group II. No severe side-effects were recorded. Ultrasound-guided needling in combination with high-energy shock-wave therapy is more effective than shock-wave therapy alone in patients with symptomatic calcific tendonitis, giving significantly higher rates of elimination of the calcium deposits, better clinical results and reduction in the need for surgery

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

We have compared the outcome of hemiarthroplasty of the shoulder in three distinct diagnostic groups, using survival analysis as used by the United Kingdom national joint registers, patient-reported outcome measures (PROMs) as recommended by Darzi in the 2008 NHS review, and transition and satisfaction questions. A total of 72 hemiarthroplasties, 19 for primary osteoarthritis (OA) with an intact rotator cuff, 22 for OA with a torn rotator cuff, and 31 for rheumatoid arthritis (RA), were followed up for between three and eight years. All the patients survived, with no revisions or dislocations and no significant radiological evidence of loosening. The mean new Oxford shoulder score (minimum/worst 0, maximum/best 48) improved significantly for all groups (p < 0.001), in the OA group with an intact rotator cuff from 21.4 to 38.8 (effect size 2.9), in the OA group with a torn rotator cuff from 13.3 to 27.2 (effect size 2.1) and in the RA group from 13.7 to 28.0 (effect size 3.1). By this assessment, and for the survival analysis, there was no significant difference between the groups. However, when ratings using the patient satisfaction questions were analysed, eight (29.6%) of the RA group were ‘disappointed’, compared with one (9.1%) of the OA group with cuff intact and one (7.7%) of the OA group with cuff torn. All patients in the OA group with cuff torn indicated that they would undergo the operation again, compared to ten (90.9%) in the OA group with cuff intact and 20 (76.9%) in the RA group. The use of revision rates alone does not fully represent outcome after hemiarthroplasty of the shoulder. Data from PROMs provides more information about change in pain and the ability to undertake activities and perform tasks. The additional use of satisfaction ratings shows that both the rates of revision surgery and PROMs need careful interpretation in the context of patient expectations

We describe the results of surgical treatment in a prospective study of 183 consecutive cases of subluxation (101) and dislocation (82) of the shoulder secondary to obstetric brachial plexus palsy between 1995 and 2000. Neurological recovery was rated ‘good’ or ‘useful’ in all children, whose lesions fell into groups 1, 2 or 3 of the Narakas classification. The mean age at operation was 47 months (3 to 204). The mean follow-up was 40 months (24 to 124). The mean gain in function was 3.6 levels (9.4 to 13) using the Mallet score and 2 (2.1 to 4.1) on the Gilbert score. The mean active global range of shoulder movement was increased by 73°; the mean range of active lateral rotation by 58° and that of supination of the forearm by 51°. Active medial rotation was decreased by a mean of 10°. There were 20 failures. The functional outcome is related to the severity of the neurological lesion, the duration of the dislocation and onset of deformity

We retrospectively reviewed 26 patients who underwent reconstruction of the shoulder for a medial rotation contracture after birth injury of the brachial plexus. Of these, 13 patients with a mean age of 5.8 years (2.8 to 12.9) received an injection of botulinum toxin type A into the pectoralis major as a surgical adjunct. They were matched with 13 patients with a mean age of 4.0 years (1.9 to 7.2) who underwent an identical operation before the introduction of botulinum toxin therapy to our unit. Pre-operatively, there was no significant difference (p = 0.093) in the modified Gilbert shoulder scores for the two groups. Post-operatively, the patients who received the botulinum toxin had significantly better Gilbert shoulder scores (p = 0.012) at a mean follow-up of three years (1.5 to 9.8). It appears that botulinum toxin type A produces benefits which are sustained beyond the period for which the toxin is recognised to be active. We suggest that by temporarily weakening some of the power of medial rotation, afferent signals to the brain are reduced and cortical recruitment for the injured nerves is improved

In 100 patients the fulcrum axis which is the line connecting the anterior tip of the coracoid and the posterolateral angle of the acromion, was used to position true anteroposterior radiographs of the shoulder. This method was then compared with the conventional radiological technique in a further 100 patients. Three orthopaedic surgeons counted the number of images without overlap between the humeral head and glenoid and calculated the amount of the glenoid surface visible in each radiograph. The analysis was repeated for intraobserver reliability. The learning curves of both techniques were studied. The amount of free visible glenoid space was significantly higher using the fulcrum-axis method (64 vs 31) and the comparable glenoid size increased significantly (8.56 vs 6.47). Thus the accuracy of the anteroposterior radiographs of the shoulder is impaired by using this technique. The intra and interobserver reliability showed a high consistency. No learning curve was observed for either technique

Replacement of the shoulder in juvenile idiopathic arthritis is not often performed and there have been no published series to date. We present nine glenohumeral hemiarthroplasties in eight patients with systemic or polyarticular juvenile idiopathic arthritis. The mean follow-up was six years (59 to 89 months). The mean age at the time of surgery was 32 years. Surgery took place at a mean of 27 years after diagnosis. The results indicated excellent relief from pain. There was restoration of useful function which deteriorated with time, in part because of progression of the systemic disease in this severely affected group. No patient has required revision to date and there has been no radiological evidence of loosening or osteolysis around the implants. We discuss the pathoanatomical challenges unique to this group. There was very little space for a prosthetic joint and, in some cases, bony deformity and the small size necessitated the use of custom-made implants

We describe the results of Copeland surface replacement shoulder arthroplasty using the mark III prosthesis in patients over 80 years of age. End-stage arthritis of the shoulder is a source of significant pain and debilitating functional loss in the elderly. An arthroplasty offers good relief of pain and may allow the patient to maintain independence. The risk-benefit ratio of shoulder replacement may be felt to be too high in an elderly age group, but there is no published evidence to support this theory. We have assessed whether the procedure was as reliable and safe as previously seen in a younger cohort of patients. Between 1993 and 2003, 213 Copeland surface replacement arthroplasty procedures were performed in our unit, of which 29 (13.6%) were undertaken in patients over the age of 80. This group of patients was followed up for a mean of 4.5 years (2.1 to 9.3). Their mean age was 84.3 years (81 to 93), the mean operating time was 40 minutes (30 to 45) and the mean in-patient stay was five days (2 to 21). There were no peri-operative deaths or significant complications. The mean Constant score adjusted for age and gender, improved from 15.1% to 77%. Copeland surface replacement shoulder arthroplasty may be performed with minimal morbidity and rapid rehabilitation in the elderly

We describe 20 patients, aged between 43 and 88 years, with delayed nerve palsy or deepening of an initial palsy caused by arterial injury from low-energy injuries to the shoulder. The onset of palsy ranged from immediately after the injury to four months later. There was progression in all the patients with an initial partial nerve palsy. Pain was severe in 18 patients, in 16 of whom it presented as neurostenalgia and in two as causalgia. Dislocation of the shoulder or fracture of the proximal humerus occurred in 16 patients. There was soft-tissue crushing in two and prolonged unconsciousness from alcoholic intoxication in another two. Decompression of the plexus and repair of the arterial injury brought swift relief from pain in all the patients. Nerve recovery was generally good, but less so in neglected cases. The interval from injury to the repair of the vessels ranged from immediately afterwards to 120 days. Delayed onset of nerve palsy or deepening of a nerve lesion is caused by bleeding and/or impending critical ischaemia and is an overwhelming indication for urgent surgery. There is almost always severe neuropathic pain

We have undertaken a prospective clinical and radiological analysis of 124 shoulder arthroplasties (113 patients) carried out for osteoarthritis. The clinical results showed improvement in the absolute Constant score and the American Shoulder and Elbow Surgeons score of 22 and 43, respectively. Both were statistically significant (p < 0.001). There was no significant difference in the scores after hemiarthroplasty and total arthroplasty in those patients with an intact rotator cuff. When revision was used as the end-point for survival at ten years, survival of 86%, or 90% if glenoid components made of Hylamer sterilised in air were omitted, was obtained in primary osteoarthritis. The most common cause for revision in the hemiarthroplasty group was glenoid pain at a mean of 1.5 years; in the total arthroplasty group it was loosening of the glenoid at a mean of 4.5 years. Analysis of pre-operative factors showed that the risk of gross loosening of the glenoid increased threefold when there was evidence of erosion of the glenoid at operation. Shoulder arthroplasty should not be delayed once symptomatic osteoarthritis has been established and should be undertaken before failure of the cuff or erosion of the glenoid are present

We performed eight osteochondral autologous transplantations from the knee joint to the shoulder. All patients (six men, two women; mean age 43.1 years) were documented prospectively. In each patient the stage of the osteochondral lesion was Outerbridge grade IV with a mean size of the affected area of 150 mm. 2. All patients were assessed by using the Constant score for the shoulder and the Lysholm score for the knee. Standard radiographs, magnetic resonance imaging and second-look arthroscopy were used to assess the presence of glenohumeral osteoarthritis and the integrity of the grafts. After a mean of 32.6 months (8 to 47), the mean Constant score increased significantly. Magnetic resonance imaging revealed good osseointegration of the osteochondral plugs and congruent articular cartilage at the transplantation site in all but one patient. Second-look arthroscopy performed in two cases revealed a macroscopically good integration of the autograft with an intact articular surface. Osteochondral autologous transplantation in the shoulder appears to offer good clinical results for treating full-thickness osteochondral lesions of the glenohumeral joint. However, our study suggests that the development of osteoarthritis and the progression of pre-existing osteoarthritic changes cannot be altered by this technique

We report a randomised controlled trial to examine the effectiveness and cost-effectiveness of arthroscopic acromioplasty in the treatment of stage II shoulder impingement syndrome. A total of 140 patients were randomly divided into two treatment groups: supervised exercise programme (n = 70, exercise group) and arthroscopic acromioplasty followed by a similar exercise programme (n = 70, combined treatment group). The main outcome measure was self-reported pain on a visual analogue scale of 0 to 10 at 24 months, measured on the 134 patients (66 in the exercise group and 68 in the combined treatment group) for whom endpoint data were available. An intention-to-treat analysis disclosed an improvement in both groups but without statistically significant difference in outcome between the groups (p = 0.65). The combined treatment was considerably more costly. Arthroscopic acromioplasty provides no clinically important effects over a structured and supervised exercise programme alone in terms of subjective outcome or cost-effectiveness when measured at 24 months. Structured exercise treatment should be the basis for treatment of shoulder impingement syndrome, with operative treatment offered judiciously until its true merit is proven

A new technique of shoulder fusion is presented using a posterior approach. After removal of the articular cartilage, a Rush pin is introduced from the spine of the scapula, through the glenoid into the medullary canal of the humerus. This is supplemented by tension-band wiring from the acromion to the neck of the humerus and a muscle pedicle graft attached to the acromion. A shoulder spica is applied for four to six weeks. Four patients with injuries to the upper brachial plexus and 14 with paralysis of the upper arm due to anterior poliomyelitis have been followed for three years. One of the 18 patients developed nonunion; she had removed her own cast prematurely. This method of fixation provides high shear resistance and low axial stiffness without deforming plastically. It does not affect bone growth in young patients, is effective in patients with osteoporosis, and gives a high rate of union

Instability after arthroplasty of the shoulder is difficult to correct surgically. Soft-tissue procedures and revision surgery using unconstrained anatomical components are associated with a high rate of failure. The purpose of this study was to determine the results of revision of an unstable anatomical shoulder arthroplasty to a reverse design prosthesis. Between 2004 and 2007, 33 unstable anatomical shoulder arthroplasties were revised to a reverse design. The mean age of the patients was 71 years (53 to 86) and their mean follow-up was 42 months (25 to 71). The mean time to revision was 26 months (4 to 164). Pain scores improved significantly (pre-operative visual analogue scale (VAS) of 7.2 (. sd. 1.6); most recent VAS 2.2 (. sd. 1.9); p = 0.001). There was a statistically significant increase in mean active forward elevation from 40.2° (. sd. 27.3) to 97.0° (. sd. 36.2) (p = 0.001). There was no significant difference in internal (p = 0.93) or external rotation (p = 0.40). Radiological findings included notching in five shoulders (15%) and heterotopic ossification of the inferior capsular region in three (9%). At the last follow-up 31 shoulders (94%) were stable. The remaining two shoulders dislocated at 2.5 weeks and three months post-operatively, respectively. According to the Neer rating system, there were 13 excellent (40%), ten satisfactory (30%) and ten unsatisfactory results (30%). Revision of hemiarthroplasty or anatomical total shoulder replacement for instability using a reverse design prosthesis gives good short-term results. Cite this article: Bone Joint J 2013;95-B:668–72

We diagnosed 50 patients (58 shoulders) with a mean age at presentation of 17.3 years, as having involuntary positional instability of the shoulder. They were managed by a programme consisting of a careful explanation, analysis of abnormal muscle couples and then muscle retraining carried out by a specialist physiotherapist. The mean follow-up was two years. Six shoulders had a poor result, but 52 were graded as good to excellent. Nine patients (12 shoulders) relapsed and required further episodes of retraining. In our experience, involuntary positional instability of the shoulder causes symptoms which interfere with normal activities; these can be controlled by a treatment plan of retraining of the muscle pattern with functional benefit. Only 19 of the patients were referred with a diagnosis of positional instability. There should be more awareness of this rather uncommon condition. Surgery is not indicated in these patients

Objectives. To report the five-year results of a randomised controlled trial examining the effectiveness of arthroscopic acromioplasty in the treatment of stage II shoulder impingement syndrome. Methods. A total of 140 patients were randomly divided into two groups: 1) supervised exercise programme (n = 70, exercise group); and 2) arthroscopic acromioplasty followed by a similar exercise programme (n = 70, combined treatment group). Results. The main outcome measure was self-reported pain as measured on a visual analogue scale. At the five-year assessment a total of 109 patients were examined (52 in the exercise group and 57 in the combined treatment group). There was a significant decrease in mean self-reported pain on the VAS between baseline and the five-year follow-up in both the exercise group (from 6.5 (1 to 10) to 2.2 (0 to 8); p < 0.001) and the combined treatment group (from 6.4 (2 to 10) to 1.9 (0 to 8); p < 0.001). The same trend was seen in the secondary outcome measures (disability, working ability, pain at night, Shoulder Disability Questionnaire and reported painful days). An intention-to-treat analysis showed statistically significant improvements in both groups at five years compared with baseline. Further, improvement continued between the two- and five-year timepoints. No statistically significant differences were found in the patient-centred primary and secondary parameters between the two treatment groups. Conclusions. Differences in the patient-centred primary and secondary parameters between the two treatment groups were not statistically significant, suggesting that acromioplasty is not cost-effective. Structured exercise treatment seems to be the treatment of choice for shoulder impingement syndrome

Residual muscle weakness in obstetric brachial plexus palsy results in soft-tissue contractures which limit the functional range of movement and lead to progressive glenoid dysplasia and joint instability. We describe the results of surgical treatment in 98 patients (mean age 2.5 years, 0.5 to 9.0) for the correction of active abduction of the shoulder. The patients underwent transfer of the latissimus dorsi and teres major muscles, release of contractures of subscapularis pectoralis major and minor, and axillary nerve decompression and neurolysis (the modified Quad procedure). The transferred muscles were sutured to the teres minor muscle, not to a point of bony insertion. The mean pre-operative active abduction was 45° (20° to 90°). At a mean follow-up of 4.8 years (2.0 to 8.7), the mean active abduction was 162° (100° to 180°) while 77 (78.6%) of the patients had active abduction of 160° or more. No decline in abduction was noted among the 29 patients (29.6%) followed up for six years or more. This procedure involving release of the contracted internal rotators of the shoulder combined with decompression and neurolysis of the axillary nerve greatly improves active abduction in young patients with muscle imbalance secondary to obstetric brachial plexus palsy

Reverse total shoulder replacement (RTSR) depends on adequate deltoid function for a successful outcome. However, the anterior deltoid and/or axillary nerve may be damaged due to prior procedures or injury. The purpose of this study was to determine the compensatory muscle forces required for scapular plane elevation following RTSR when the anterior deltoid is deficient. The soft tissues were removed from six cadaver shoulders, except for tendon attachments. After implantation of the RTSR, the shoulders were mounted on a custom-made shoulder simulator to determine the mean force in each muscle required to achieve 30° and 60° of scapular plane elevation. Two conditions were tested: 1) Control with an absent supraspinatus and infraspinatus; and 2) Control with anterior deltoid deficiency. Anterior deltoid deficiency resulted in a mean increase of 195% in subscapularis force at 30° when compared with the control (p = 0.02). At 60°, the subscapularis force increased a mean of 82% (p < 0.001) and the middle deltoid force increased a mean of 26% (p = 0.04). Scapular plane elevation may still be possible following an RTSR in the setting of anterior deltoid deficiency. When the anterior deltoid is deficient, there is a compensatory increase in the force required by the subscapularis and middle deltoid. Attempts to preserve the subscapularis, if present, might maximise post-operative function

Between 1976 and 2004, 38 revision arthroplasties (35 patients) were performed for aseptic loosening of the humeral component. The mean interval from primary arthroplasty to revision was 7.1 years (0.4 to 16.6). A total of 35 shoulders (32 patients) were available for review at a mean follow-up of seven years (2 to 19.3). Pre-operatively, 34 patients (97%) had moderate or severe pain; at final follow-up, 29 (83%) had no or only mild pain (p < 0.0001). The mean active abduction improved from 88° to 107° (p < 0.01); and the mean external rotation from 37° to 46° (p = 0.27). Excellent or satisfactory results were achieved in 25 patients (71%) according to the modified Neer rating system. Humeral components were cemented in 29, with ingrowth implants used in nine cases. There were 19 of standard length and 17 were longer (two were custom replacements and are not included). Bone grafting was required for defects in 11 humeri. Only two glenoid components were left unrevised. Intra-operative complications included cement extrusion in eight cases, fracture of the shaft of the humerus is two and of the tuberosity in four. There were four re-operations, one for recurrent humeral loosening, with 89% survival free of re-operations at ten years. Revision surgery for aseptic loosening of the humeral component provides reliable pain relief and modest improvement of movement, although there is a substantial risk of intra-operative complications. Revision to a total shoulder replacement gives better results than to a hemiarthroplasty

We performed a double-blind, randomised controlled trial to assess the effectiveness of a continuous-infusion brachial plexus block with levobupivacaine compared with that of a standard single injection for the management of post-operative pain after surgery on the shoulder. Eight patients were randomised to receive a pre-operative brachial plexus block using 30 ml of levobupivacaine 0.5% with adrenaline 1:200 000 followed by insertion of a 20-gauge polyamide catheter. This was connected to a disposable elastometric pump, set immediately after surgery to administer a continuous flow of levobupivacaine 0.25% at a rate of 5 ml per hour. The other eight patients were randomised to receive only the initial injection of 30 ml. The study was double-blinded with the aid of sham catheters and clamped pumps. All patients were given regular paracetamol and were prescribed morphine through a patient-controlled analgesia pump. Motor and sensory block assessments, visual analogue scale pain scores and consumption of morphine were recorded after the operation and then at 6, 12 and 24 hours after administration of the block. Satisfactory motor and sensory block was achieved in all patients. The mean visual analogue scale pain score at 12 hours and consumption of morphine at 24 hours after injection were significantly lower (p < 0.05) in the continuous-infusion group. This group also took longer to request their first additional analgesia and reported a significantly higher overall level of satisfaction. Our study has shown that continuous interscalene infusion of levobupivacaine is an effective method of post-operative analgesia after major surgery of the shoulder

Reversed shoulder prostheses are increasingly being used for the treatment of glenohumeral arthropathy associated with a deficient rotator cuff. These non-anatomical implants attempt to balance the joint forces by means of a semi-constrained articular surface and a medialised centre of rotation. A finite element model was used to compare a reversed prosthesis with an anatomical implant. Active abduction was simulated from 0° to 150° of elevation. With the anatomical prosthesis, the joint force almost reached the equivalence of body weight. The joint force was half this for the reversed prosthesis. The direction of force was much more vertically aligned for the reverse prosthesis, in the first 90° of abduction. With the reversed prosthesis, abduction was possible without rotator cuff muscles and required 20% less deltoid force to achieve it. This force analysis confirms the potential mechanical advantage of reversed prostheses when rotator cuff muscles are deficient

Despite the expansion of arthroscopic surgery of the shoulder, the open deltopectoral approach to the shoulder is still frequently used, for example in fracture fixation and shoulder replacement. However, it is sometimes accompanied by unexpected bleeding. The cephalic vein is the landmark for the deltopectoral interval, yet its intimate relationship with the deltoid artery, and the anatomical variations in that structure, have not previously been documented. In this study the vascular anatomy encountered during 100 consecutive elective deltopectoral approaches was recorded and the common variants described. Two common variants of the deltoid artery were encountered. In type I (71%) it crosses the interval and tunnels into the deltoid muscle without encountering the cephalic vein. However, in type II (21%) it crosses the interval, reaches the cephalic vein and then runs down, medial to and behind it, giving off several small arterial branches that return back across the interval to the pectoralis major. Several minor variations were also seen (8%). These variations in the deltoid artery have not previously been described and may lead to confusion and unexpected bleeding during this standard anterior surgical approach to the shoulder. Cite this article: Bone Joint J 2013;95-B:657–9

We retrospectively identified 18 consecutive patients with synovial chrondromatosis of the shoulder who had arthroscopic treatment between 1989 and 2004. Of these, 15 were available for review at a mean follow-up of 5.3 years (2.3 to 16.5). There were seven patients with primary synovial chondromatosis, but for the remainder, the condition was a result of secondary causes. The mean Constant score showed that pain and activities of daily living were the most affected categories, being only 57% and 65% of the values of the normal side. Surgery resulted in a significant improvement in the mean Constant score in these domains from 8.9 (4 to 15) to 11.3 (2 to 15) and from 12.9 (5 to 20) to 18.7 (11 to 20), respectively (unpaired t-test, p = 0.04 and p < 0.0001, respectively). Movement and strength were not significantly affected. Osteoarthritis was present in eight patients at presentation and in 11 at the final review. Recurrence of the disease with new loose bodies occurred in two patients from the primary group at an interval of three and 12 years post-operatively. In nine patients, loose bodies were also present in the bicipital groove; seven of these underwent an open bicipital debridement and tenodesis. We found that arthroscopic debridement of the glenohumeral joint and open debridement and tenodesis of the long head of biceps, when indicated, are safe and effective in relieving symptoms at medium-term review

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

We have analysed the Constant-Murley (1987) assessment for 25 patients with shoulder pathology. We found the score easy to use, with low inter- and intraobserver errors, but sufficiently imprecise in repeated measurements to give concern in its use for clinical follow-up of patients. We have calculated 95% confidence limits for a single assessment to be within 16 to 20 points in most cases. In addition, we found that all our subjects with instability as their main problem scored within five points of the maximum; this suggests that the scoring method may need to be revised for use on these patients

We analysed the long-term results of arthrodesis of the shoulder after infection in 15 patients. At the time of operation, 14 cultures were positive for Staphylococcus aureus. The mean follow-up was 8.3 years (3 to 14) and 90% of the patients were satisfied with the outcome. There were complications in five patients (33%); in three there was nonunion with loosening of the implant. One patient had a sound bony union but with a persistent sinus six years after arthrodesis and another had a sinus which healed after the metal was removed. Four of these five patients (80%) were heavy smokers (> 20 cigarettes/day). Cancellous bone grafting did not affect the incidence of complications. The mean age of the patients with complications was 58.6 v 48.6 years for those without (p = 0.2808 ; not significant). Those with complications had had more previous operations (6.4 v 2.5, p < 0.05). Antibiotics, as determined by the bacteriological cultures, were administered for six weeks. The complication rate was higher in patients with active sepsis but the younger the patient and the fewer number of previous operations (< 50 years, < four previous operations), the better was the outcome. Considering the rate of complications, we recommend early surgery in these patients

Opinion varies as to the incidence of nerve lesions in anterior dislocation of the shoulder after low-velocity trauma. Most studies are retrospective or do not use EMG. We have investigated the incidence and the clinical consequences of nerve lesions in a prospective study by clinical and electrophysiological examination. Axonal loss was seen in 48% of 77 patients. The axillary nerve was most frequently involved (42%). Although recovery as judged by EMG and muscle strength was almost complete, function of the shoulder was significantly impaired in patients with lesions of the axillary and suprascapular nerves. Unfavourable prognostic factors are increasing age and the presence of a haematoma. It is not necessary to carry out EMG routinely; an adequate programme of physiotherapy is important. In patients with a severe paresis, EMG is essential after three weeks

A reversed Delta III total shoulder prosthesis was retrieved post-mortem, eight months after implantation. A significant notch was evident at the inferior pole of the scapular neck which extended beyond the inferior fixation screw. This bone loss was associated with a corresponding, erosive defect of the polyethylene cup. Histological examination revealed a chronic foreign-body reaction in the joint capsule. There were, however, no histological signs of loosening of the glenoid base plate and the stability of the prosthetic articulation was only slightly reduced by the eroded rim of the cup

The outcome of an anatomical shoulder replacement depends on an intact rotator cuff. In 1981 Grammont designed a novel large-head reverse shoulder replacement for patients with cuff deficiency. Such has been the success of this replacement that it has led to a rapid expansion of the indications. We performed a systematic review of the literature to evaluate the functional outcome of each indication for the reverse shoulder replacement. Secondary outcome measures of range of movement, pain scores and complication rates are also presented

We investigated the function of biceps in 18 patients (19 shoulders) with lesions of the rotator cuff. Their mean age was 59 years. Another series of 18 patients (19 shoulders) with normal rotator cuffs as seen on MRI acted as a control group. Their mean age was 55 years. A brace was used to maintain contraction of biceps during elevation. Anteroposterior radiographs were obtained with the arm elevated at 0°, 45° and 90° with and without contraction of biceps. The distance between the centre of the head of the humerus and the glenoid was compared in the two groups. We found that in the group with tears there was significantly greater proximal migration of the head of the humerus at 0° and 45° of elevation without contraction of biceps but depression of the head of the humerus at 0°, 45° and 90° when biceps was functioning. We conclude that biceps is an active depressor of the head of the humerus in shoulders with lesions of the rotator cuff

Radiographs of the shoulders of 84 asymptomatic individuals aged between 40 and 83 years were evaluated to determine changes in 23 specific areas. Two fellowship-trained orthopaedic radiologists graded each area on a scale of 0 to II (normal 0, mild changes I, advanced changes II). Logistic regression analysis indicated age to be a significant predictor of change (p < 0.05) for sclerosis of the medial acromion and lateral clavicle, the presence of subchondral cysts in the acromion, formation of osteophytes at the inferior acromion and clavicle, and narrowing and degeneration of the acromioclavicular joint. Gender was not a significant predictor (p > 0.05) for radiological changes. Student’s t-test determined significance (p < 0.05) between age and the presence of medial acromial and lateral clavicular sclerosis, subchondral acromial cysts, inferior acromial and clavicular osteophytes, and degeneration of the acromioclavicular joint. Radiological analysis in conditions such as subacromial impingement, pathology of the rotator cuff, and acromioclavicular degeneration should be interpreted in the context of the symptoms and normal age-related changes

We have previously described the short-term outcome of the use of reverse shoulder arthroplasty in the treatment of acute complex proximal humeral fractures in the elderly. We now report the clinical and radiological outcome of 36 fractures at a mean of 6.6 years (1 to 16). Previously, at a mean follow-up of 6 years (1 to 12) the mean Constant score was 58.5; this was reduced to 53 points with the further follow-up. A total of 23 patients (63%) had radiological evidence of loosening of the glenoid component. Nevertheless, only one patient had aseptic loosening of the baseplate at 12 years’ follow-up.

The reduction in the mean Constant score with longer follow-up and the further development of scapular notching is worrying.

New developments in design, bearing surfaces and surgical technique, and further follow-up, will determine whether reverse shoulder arthroplasty has a place in the management of complex proximal humeral fractures in the elderly.

We compared the long-term function of subscapularis after the Latarjet procedure using two surgical approaches. We treated 102 patients (106 shoulders) with a mean age of 26.8 years (15 to 51) with involuntary unidirectional recurrent instability. The operation was carried out through an L-shaped incision with trans-section of the upper two-thirds of the muscle in 69 cases and with a subscapularis split in 37. All clinical results were assessed by the Rowe and the Duplay scores and the function of subscapularis by evaluating the distance and strength at the lift-off position. Bilateral CT was performed in 77 patients for assessment of fatty degeneration. The mean follow-up was 7.5 years (2 to 15) and 18% of cases were lost to follow-up. The mean Duplay score was 82 of 100 for the L-shaped incision group and 90 of 100 for those with a subscapularis split (p = 0.02). The mean fatty degeneration score was 1.18 after an L-shaped incision compared with 0.12 after subscapularis split (p = 0.001). The subscapularis split approach is therefore recommended.

We reviewed 39 patients with displaced three- and four-part fractures of the humerus. In 21 patients (group A) we had used an anatomical prosthesis for the humeral head and in 18 (group B) an implant designed for fractures.

When followed up at a mean of 29.3 months after surgery the overall Constant score was 51.9 points; in group A it was 51.5 and in group B 52.4 points. The subjective satisfaction of the patients was assessed using a numerical rating scale and was similar in both groups. In group A complete healing of the tuberosities was found in 29% and 50% in group B. Partial integration was seen in 29% of group A and in only one patient in group B, while resorption was noted in 43% of group A and 44% of group B. The functional outcome was significantly better in patients with complete or partial healing of the tuberosities (p = 0.022). The specific trauma prosthesis did not lead to better healing of the tuberosities. The difference in clinical outcome obtained by the two designs did not reach statistical significance.