A rigorous approach to developing, delivering and documenting
rehabilitation within randomised controlled trials of surgical interventions
is required to underpin the generation of reliable and usable evidence.
This article describes the key processes used to ensure provision
of good quality and comparable rehabilitation to all participants
of a multi-centre randomised controlled trial comparing surgery
with conservative treatment of proximal humeral fractures in adults. These processes included the development of a patient information
leaflet on self-care during sling immobilisation, the development
of a basic treatment physiotherapy protocol that received input
and endorsement by specialist physiotherapists providing patient
care, and establishing an expectation for the provision of home
exercises. Specially designed forms were also developed to facilitate
reliable reporting of the physiotherapy care that patients received.Objectives
Methods
Prevalence of rotator cuff tears increases with advancing age (Ellman et al). In spite of proximal humeral fractures being common in the elderly, the influence of a coexistent rotator cuff tear on outcome has, to our knowledge, not been previously investigated. This study prospectively assessed whether the presence of a rotator cuff tear in association with a proximal humeral fracture influences functional prognosis. 85 patients treated conservatively for proximal humeral fractures were evaluated prospectively with Ultrasonography to determine the status of the rotator cuff. Every patient was managed by immobilisation of the arm in a sling for two weeks followed by a course of physiotherapy based on the Neer regime. Functional outcome was measured using the Constant shoulder score and the Oxford shoulder score, at 3-months and 12-months post injury. Sixty-six of the 85 patients were female. The fractures were equally distributed for hand dominance. There were 27 patients with an undisplaced fracture, 34 patients with Neer's Type II fracture and 24 patients with Neer's Type III and IV fracture. There were 43 patients with full thickness cuff tears and 42 patients with no cuff tear or a partial thickness tear. Full thickness cuff tears were much more frequent in the over 60 year age group, which is consistent with the known increased incidence of cuff tears with increasing age. The outcome scores at 3 and 12 months showed no statistically significant difference for either the Constant score or the Oxford score with regards to cuff integrity. Analysis of these scores showed no correlation between presence or absence of a full thickness cuff tear and shoulder function The results of this study indicate that rotator cuff integrity is not a predictor of shoulder function at 12 months following proximal humeral fracture, as measured by outcome scores. This suggests that there is therefore no clinical indication for routine imaging of the rotator cuff in patients for whom conservative management is the preferred treatment option.
Large and massive rotator cuff tears can cause persistent pain and significant disability. These tears are often chronic with substantial degeneration of the involved tendons. Surgical treatment is challenging and the functional outcome after repair less predictable then for smaller tears. The aim of this study was to determine the functional outcome and rate of re-rupture after mini-open repair of symptomatic large and massive rotator cuff tears using a modified two-row technique. Twenty-four patients, who were operated on under the care of a single surgeon between 2003 and 2006, were included in this study. Patients were assessed prospectively before and at a mean of 27 months after surgery using Constant Score and Oxford Shoulder Score. This assessment was carried out by an independent physiotherapist specialising in shoulder rehabilitation. At follow-up an ultrasound was carried out by a musculoskeletal radiographer to determine the integrity of the rotator cuff repair. Patient satisfaction was assessed using a simple questionnaire. The mean Constant Score improved significantly from 36 preoperatively to 68 postoperatively (p<
0.0001), the mean Oxford Shoulder Score from 39 to 20 (p<
0.0001). Four patients (16.7%) had a re-rupture diagnosed by ultrasound. 87.5% of patients were satisfied with the outcome of their surgery. Tear size and repair integrity did not significantly influence functional outcome. 87.5% of patients were satisfied or very satisfied with the outcome of their surgery. This study shows that the two-row repair of large and massive rotator cuff tears using a mini-open approach is an effective method of repair with a comparatively low re-rupture rate. It significantly improves the functional outcome and leads to a very high patient satisfaction. We conclude that these results justify repair of large to massive rotator cuff tears when possible, irrespective of chronicity of symptoms.
The aim of this study was to determine the functional outcome and rate of re-tears following mini-open repair of symptomatic large and massive tears of the rotator cuff using a two-row technique. The 24 patients included in the study were assessed prospectively before and at a mean of 27 months (18 to 53) after surgery using the Constant and the Oxford Shoulder scores. Ultrasound examination was carried out at follow-up to determine the integrity of the repair. Patient satisfaction was assessed using a simple questionnaire. The mean Constant score improved significantly from 36 before to 68 after operation (p <
0.0001) and the mean Oxford Shoulder score from 39 to 20 (p <
0.0001). Four of the 24 patients (17%) had a re-tear diagnosed by ultrasound. A total of 21 patients (87.5%) were satisfied with the outcome of their surgery. The repair remained intact in 20 patients (83%). However, the small number of re-tears (four patients) in the study did not allow sufficient analysis to show a difference in outcome in relation to the integrity of the repair.
The outcome scores at 3 and 12 months showed no statistically significant difference for either the Constant score or the Oxford score with regards to cuff integrity. Analysis of these scores showed no correlation between presence or absence of a full thickness cuff tear and shoulder function
A trend towards lesser degrees of improvement in the outcome scores was noted with increasing age. The degree of improvement in the outcome scores was not affected by sex, limb dominance or fracture type (Neer’s classification).
Statistical analysis of pre- and post-operative Constant scores showed that, in ≤9 mm group CS increased significantly by 21.5, p=0.02, 95% CI (4.9, 38.1). CS increased in ≥10mm group by 22.8, p<
0.01, 95%(11.5, 34.1). Comparing the change in CS between these two groups with different tears size, there was no significant difference (2-sample t-test, t=0.15, 20df, p=0.88). To determine whether having BT tear affects pre- and post-operative Constant scores, all BTs were grouped together and compared with the group of patients with intact cuff. In the group with BTs, average Constant scores increased significantly (paired t-test, t=5.24, 21df, p<
0.01) by 22.2 with 95% CI (13.4, 31.0). In the group with no tears, average Constant scores increased significantly (paired t-test, t=5.17, 17df, p<
0.01) by 26.6, 95% CI (15.8, 37.5). Comparing the levels of absolute change in Constant scores from pre- to post-operation between the two groups there is no difference in outcome between patients with a tear and those without a tear (2-sample t-test, t=1.03, 38df, p=0.31).
The mean Constant score was 88 (s.d. 12). The mean Imatani score was 86 (s.d. 16). Most patients were satisfied with the operation (90%). There was one case of rupture through the central portion of the Surgilig, and following extensive laboratory analysis, the ligament has been modified since. One patient had a fracture of his coracoid while lifting heavy weights. In 4 patients there was clinical and radiological evidence of loosening of the screw but only 1 complained of this being a problem.
Systematic studies are required to examine the effects on outcomes of alternative treatments and surgical techniques in the management of Orthopaedic conditions. Functional outcome scores provide reliable and valid judgments of health status and benefits of the treatment. We undertook a prospective study to assess the functional outcome in patients treated conservatively for proximal humeral fractures. 103 patients treated conservatively for a proximal humeral fracture were followed prospectively. Constant shoulder score and Oxford shoulder score were recorded at 3 months and 12 months follow-up. A trend towards lesser degrees of improvement in the outcome scores was noted with increasing age. The degree of improvement in the outcome scores was not affected by sex, limb dominance or fracture type (Neer’s classification). This information gives a guide to average behaviour in different groups of individuals with conservative treatment for proximal humeral fractures. We could then using this data postulate what would constitute a clinically relevant difference and calculate study numbers required while assessing other form of treatments for such fractures
The data was analysed to determine if the presence of a full thickness rotator cuff tear influenced functional outcome in these patients. The null hypothesis has not been disproved. There is no statistically significant difference in outcome with presence of an associated full thickness rotator cuff tear with proximal humeral fractures.
To determine if the surface area of partial thickness (<
50%), Bursal side tears of the cuff influence outcome following Subacromial Decompression. Shoulder function using Constant score (CS) was recorded before and a minimum of one year after Arthroscopic Subacromial Decompression (ASD) in patients undergoing surgery for primary impingement. In patients who had partial thickness, Bursal side tears (BT), the length of the tear in its largest dimension (surface area) was measured. These patients were divided into two groups according to the tear surface area (≤9 mm and ≥10mm) .To determine whether having a BT (<
50% thickness) or its surface area affect pre and postoperative CS, t-tests were performed. 110 patients underwent ASD over a one-year period for primary impingement. 22 patients with partial thickness BT and18 patients with intact rotator cuff were included in this study. In 10 patients, the BTwas ≤9 mm (mean7mm) and in 12 patients BTwas ≥10mm(mean13mm). Statistical analysis of Pre-&
postoperative Constant scores showed that, in ≤9 mm group CS increased significantly by 21.5, p=0.02, 95% CI (4.9, 38.1). CS increased in ≥10mm group by 22.8, p<
0.01, 95%(11.5, 34.1). Comparing the change in CS between these two groups with different tears size, there was no significant difference (2-sample t-test, t=0.15, 20df, p=0.88). To determine whether having BT tear affects pre- and post-operative Constant scores, all BTs were grouped together and compared with the group of patients with intact cuff. In the group with BTs, average Constant scores increased significantly (paired t-test,t=5.24,21df,p<
0.01) by 22.2 with 95% CI (13.4, 31.0). In the group with no tears, average Constant scores increased significantly (paired t-test,t=5.17,17df,p<
0.01) by 26.6, 95% CI (15.8, 37.5). Comparing the levels of absolute change in Constant scores from pre- to post-operation between the two groups there is no difference in outcome between patients with a tear and those without a tear (2-sample t-test, t=1.03, 38df, p=0.31). We conclude that ASD yields satisfactory results in patients with BTs involving <
50% thickness, irrespective of the surface area of the tear.