Comparison between surgery and physiotherapy in the treatment of small and medium-sized tears of the rotator cuff A RANDOMISED CONTROLLED STUDY OF 103 PATIENTS WITH ONE-YEAR FOLLOW-UP S. Moosmayer, G. Lund, U. Seljom, I. Svege, T. Hennig, R. Tariq, H.-J. Smith From Martina Hansen’s Hospital, Baerum, Norway
In order to compare the outcome from surgical repair and physiotherapy, 103 patients with symptomatic small and medium-sized tears of the rotator cuff were randomly allocated to one of the two approaches. The primary outcome measure was the Constant score, and secondary outcome measures included the self-report section of the American Shoulder and Elbow Surgeons score, the Short Form 36 Health Survey and subscores for shoulder movement, pain, strength and patient satisfaction. Scores were taken at baseline and after six and 12 months by a blinded assessor. Nine patients (18%) with insufficient benefit from physiotherapy after at least 15 treatment sessions underwent secondary surgical treatment. Analysis of between-group differences showed better results for the surgery group on the Constant scale (difference 13.0 points, p - 0.002), on the American Shoulder and Elbow surgeons scale (difference 16.1 points, p < 0.0005), for pain-free abduction (difference 28.8°, p = 0.003) and for reduction in pain (difference on a visual analogue scale -1.7 cm, p < 0.0005).
©2010 British Editorial Society of Bone and Joint Surgery doi:10.1302/0301-620X.92B1. 22609 $2.00
Which patients with rotator cuff tears should have surgical treatment and which should have physiotherapy remains unclear. Early surgical repair is essential for younger, active patients with acute tears and severe functional deficit.1 In other cases, however, surgery is not indicated and non-operative treatment may be recommended. This has the advantage of less treatment-related morbidity, but should only be preferred if the short- and long-term results are comparable to those of surgical repair. Earlier studies regarding either tendon repair2-5 or physiotherapy6-8 have shown benefit for both approaches. However, the studies are difficult to compare because of differing study populations, methods of treatment and evaluation, and periods of followup. Most studies of non-operative treatment are retrospective,6,9-11 present pre-selected groups, and exclude from analysis those patients who were operated upon after failed conservative treatment, the effect of which may have been overestimated. The purpose of this study was to present a controlled, randomised trial comparing operative repair with physiotherapy in the treatment of small and medium-sized full-thickness tears of the rotator cuff.
J Bone Joint Surg [Br] 2010;92-B:83-91. Received 17 March 2009; Accepted after revision 14 August 2009
Patients and Methods The study was a single-centre, randomised clinical trial with a minimum follow-up of
S. Moosmayer, MD, Orthopaedic Surgeon Department of Orthopaedic Surgery G. Lund, BSc, Physiotherapist U. Seljom, BSc, Physiotherapist I. Svege, BSc, Physiotherapist Department of Physiotherapy T. Hennig, BSc, Occupational Therapist Department of Occupational Therapy Martina Hansen’s Hospital , P. O. B. 23, 1306 Baerum Postterminal, Norway. R. Tariq, MD, Radiologist Unilab Diagnostics, Middelthunsgate 23, 0368 Oslo, Norway. H.-J. Smith, MD, PhD, Radiologist, Professor Department of Radiology Oslo University Hospital, Rikshospitalet, 0027 Oslo, Norway. Correspondence should be sent to Dr S. Moosmayer; e-mail:
[email protected]
VOL. 92-B, No. 1, JANUARY 2010
12 months. Between September 2004 and October 2007, 103 patients with symptomatic small (< 1 cm) or medium-sized (1 cm to 3 cm) tears of the rotator cuff were randomly allocated to operative treatment or physiotherapy. The primary outcome measure was the Constant score.12 Secondary outcome measures included the self-report section of the American Shoulder and elbow surgeons (ASES)13 score, the short form (SF-36) Health survey,14 measuring results for pain, strength and pain-free mobility of the shoulder, and treatment satisfaction. The null hypothesis was that there would be no significant difference in treatment benefit between the surgical and the non-surgical group. The study was approved by our regional health ethics board and written informed consent obtained from all participants before randomisation. Patients from the Oslo region deemed by their general practitioners to have a rotator cuff lesion and referred to our hospital were screened for inclusion by one orthopaedic surgeon (SM). The necessary criteria were lateral shoulder pain at rest or with exercise, a painful arc, positive impingement signs and a passive range of movement of at least 140° for abduction and flexion. Further inclusion criteria included the demonstration of a fullthickness tear by sonography and MRI, a tear size of not more than 3 cm on short and long axis ultrasound scans and muscle atrophy on 83
84
S. MOOSMAYER, G. LUND, U. SELJOM, I. SVEGE, T. HENNIG, R. TARIQ, H.-J. SMITH
Table I. Scoring results for the secondary surgery group at baseline, from additional pre-operative measuring, and at six and 12 months’ follow-up Outcome
Secondary surgery group (n = 9)*
Constant score (range 0 to 100) Baseline Pre-operative measuring 6 months 12 months
36.2 35.9 57.9 69.8
(27.3 to 45.2) (26.9 to 44.9) (43.8 to 72.0) (55.1 to 84.4)
ASES† score (range 0 to 100) Baseline Pre-operative measuring 6 months 12 months
42.1 48.9 75.4 88.9
(30.1 to 54.2) (32.6 to 65.2) (59.2 to 91.7) (77.4 to 100.0)
* values are given as means, with the 95% confidence intervals in parentheses † ASES, American Society of Shoulder and Elbow Surgeons
MRI not exceeding stage 2, according to the classification of Thomazeau et al.15 Traumatic and atraumatic tears were included. Exclusion criteria included age < 18 years, tears with an absolute indication for surgery such as those involving substantial parts of the subscapularis tendon, the presence of other local or systemic diseases affecting shoulder function, previous tendon surgery on the relevant shoulder, medical comorbidities and an inability to comply with follow-up. A computer-generated randomisation list (block length 20, ratio 1:1) was drawn up by our statistician. Sequentially numbered, sealed envelopes were used to assign treatment according to the participants’ study number, given at baseline assessment. The randomisation sequence was concealed from the study’s collaborators until treatment was assigned. Only the outcome assessor (TH) remained blinded throughout the study. The operations were performed in a standard manner by mini-open (nine patients) or open (42 patients) tendon repair. All were performed in the deck-chair position under interscalene block regional anaesthesia and total intravenous anaesthesia without the use of inhalational agents, by one of three experienced orthopaedic surgeons (SM, KTN, NK). Following diagnostic arthroscopy and through a deltoid splitting approach, an anteroinferior acromioplasty was performed as described by Neer.16 With the arm at the side, the rotator cuff was mobilised until the tear was fully exposed. The footprint was prepared to bleeding bone and tendon repair performed with a combination of tendon-to-tendon and tendon-to-bone techniques by passing sutures through bone tunnels in the greater tuberosity. The deltoid was repaired to the acromion through drill holes. Tenodesis of the long head of biceps tendon was performed in 18 patients in whom arthroscopy had shown inflammation or a partial tear. Mini-open tendon repair differed from open repair by a shorter incision and arthroscopic acromioplasty.
Post-operatively the arm was immobilised in a sling and passive range-of-movement exercises commenced. Activeassisted movements were initiated after six weeks, and supplemented by strengthening exercises 12 weeks after surgery. Patients randomised to the non-surgical group received outpatient treatment at our hospital by one of four physiotherapists experienced in conservative shoulder management (GL, US, BH, IS). A rehabilitation programme describing treatment goals and methods was planned before the study. Non-surgical treatment was given on the basis of this programme in a non-standardised manner according to clinical findings and progress. Treatment sessions of 40 minutes were given on average twice weekly for 12 weeks, and with increasing intervals during the following six to 12 weeks. Particular attention was directed towards correction of upper quarter posture and the restoration of scapulothoracic and glenohumeral muscular control and stability. Local glenohumeral control was addressed by exercises to centre the humeral head in the glenoid fossa. Isometric exercises and exercises against eccentric and concentric resistance for shoulder rotators were given. When local glenohumeral control was achieved, exercises were given with increasing loads and progressed from neutral to more challenging positions. During all exercises, scapular stability had to be maintained. Additional exercises were given for specific demands in work, sports and leisure activities.17-19 Patients who did not improve after at least 15 sessions of physiotherapy were re-examined by an orthopaedic surgeon (SM), and additional testing with outcome scores was performed. If inadequate improvement was confirmed (Table I), secondary surgical treatment was offered. The results of scoring from additional testing were considered as final results from non-surgical treatment and carried forward to the six- and 12-month analyses. After secondary surgical treatment these patients were followed as a separate secondary surgery group. Primary and secondary study scores were performed at baseline and six and 12 months after intervention. At the 12-month follow-up, satisfaction was assessed on a visual analogue scale (VAS) and, for the surgical treatment group, tendon healing was assessed on MRI. This was performed on a 1.5 T scanner (Signa, GE Medical Systems, Waukesha, Wisconsin). All images were interpreted by the same musculoskeletal radiologist (RT). A re-tear of the rotator cuff was diagnosed if a fluid-like signal extending from the articular to the bursal surface of the tendon was shown on T2-weighted images. A partial-thickness tear was diagnosed if the fluid signal did not traverse the full thickness of the tendon.20-23 The Constant score12 is a shoulder-specific outcome instrument. Its inter-observer reliability was established in the original paper and a more complete assessment of its reliability in patients with shoulder pathology has been performed by Conboy et al.24 The system uses a combination of subjective and examiner-derived components to assess shoulder function. A maximal score of 100 points is achievable. THE JOURNAL OF BONE AND JOINT SURGERY
COMPARISON BETWEEN SURGERY AND PHYSIOTHERAPY IN THE TREATMENT OF SMALL AND MEDIUM-SIZED TEARS OF THE ROTATOR CUFF
85
Assessed for eligibility (n = 281) Excluded: - living too far from hospital (n = 6) - refused randomisation (n = 63) - tear size > 3 cm (n = 58) - atrophy exceeding grade 2 (n = 20) - additional diagnosis affecting the shoulder (n = 16) - absolute indication for operation (n = 12) - medical contraindications (n = 3) Randomised (n = 103)
Allocated to surgery (n = 52)
Received allocated intervention (n = 51) Did not receive allocated intervention (n = 1)
Allocated to physiotherapy (n = 51)
Failed physiotherapy (n = 9)
Additional pre-operative follow-up (n = 9)
Received allocated intervention (n = 51)
Secondary surgery (n = 9) n=3
6 months follow-up (n = 51) Last result carried forward (n = 1)
6 months follow-up (n = 9)
6 months follow-up (n = 48) Last result carried forward (n = 3) n=6
12 months follow-up (n = 51) Last result carried forward (n = 1)
12 months follow-up (n = 42) Last result carried forward (n = 9)
12 months follow-up (n = 9)
Fig. 1 Flow diagram showing the patients through the study.
All examiner-derived measurements were performed with the patient wearing a T-shirt that covered the shoulder. The self-report section of the ASES score13 consists of parts for pain and shoulder function, each contributing 50 points to a maximum score of 100. The system’s validity, reliability and responsiveness have been demonstrated.25 The SF-36 is a generic measurement of health-related quality of life. It comprises eight component scales and two summary scales for physical and mental health. Each scale ranges from 0 to 100 points, with 100 indicating the best possible health condition. The validity of the paramVOL. 92-B, No. 1, JANUARY 2010
eters has been documented.26 Sensitivity and responsiveness have been demonstrated for measurement of the relative impact of shoulder pathologies and the benefit of treatment.27-31 Subscores for shoulder movement were measured with a goniometer and shoulder strength was measured with a hand-held spring balance according to Constant.12 Statistical analysis. For sample size calculation, a betweengroups difference of 12 points on the Constant scale at 12 months was assumed to represent clinical relevance.32-34 On condition of a within-group SD of 20 points on the Con-
86
S. MOOSMAYER, G. LUND, U. SELJOM, I. SVEGE, T. HENNIG, R. TARIQ, H.-J. SMITH
Table II. Patient characteristics at time of enrolment Surgery group
Physiotherapy group
Number of patients Mean age in years (range) Gender* (M:F) Affected side* (R:L) Tear on dominant/non-dominant side* Shoulder-demanding activities* (Y:N) Duration of symptoms in months† (SD)
52 59 (44 to 75) 37:15 31:21 33:19 26:26 12.3 (18.7)
51 61 (46 to 75) 36:15 29:22 31:20 28:23 9.8 (9.8)
Tear size on ultrasound in mm† (SD) Short axis Long axis
15.6 (6.7) 14.9 (5.7)
14.3 (6.3) 14.7 (6.9)
Type of injury* Adequate trauma Inadequate trauma Atraumatic
24 6 22
16 13 22
Occupational situation* On job On sick note Retired Receiving disability benefit
23 15 11 3
24 8 17 2
Earlier treatment* Physiotherapy Cortisone injections NSAID‡ None
28 5 7 12
21 10 9 11
Muscle atrophy on MRI* Grade 0 Grade 1 Grade 2 MRI not available
26 12 13 1
23 18 10 0
Localisation of tear on ultrasound* Supraspinatus Supraspinatus and infraspinatus Supraspinatus and subscapularis
37 14 1
40 10 1
* values are given as number of patients † values are given as mean and SD ‡ NSAID, non-steroidal anti-inflammatory drugs
stant scale, 102 patients would be needed to obtain a power of 0.85 and a significance level of 0.05. All patients in the study were analysed on the basis of an intention-to-treat principle. This means that for patients in the physiotherapy group who changed treatment, the final score before secondary surgery was carried forward to the six- and 12-month analyses. Patient characteristics at baseline were compared between groups by t-tests, chi-squared tests and Mann-Whitney U tests. Testing of our null hypothesis (no difference in treatment benefit between groups) was performed by a linear mixed model with an unstructured covariance matrix. The time of follow-up and choice of treatment were used as categorical variables, and an interaction term between time and treatment was included.
Between-group differences are given with 95% confidence intervals and p-values. The results of patient satisfaction at 12 months were compared between groups by a Mann-Whitney U test.
Results A total of 52 patients were allocated to surgical treatment and 51 to physiotherapy (Fig. 1). At baseline, demographic data (Table II) and study scores (Tables III and IV) were comparable between the groups (p = 0.12 to 1.00). Patients allocated to the physiotherapy group completed a mean of 24 (9 to 55) training sessions. Nine patients (18%) in the physiotherapy group showed no improvement after a mean of 24 (15 to 34) sessions and underwent surgery. One patient, allocated to surgical treatment, withdrew from the THE JOURNAL OF BONE AND JOINT SURGERY
COMPARISON BETWEEN SURGERY AND PHYSIOTHERAPY IN THE TREATMENT OF SMALL AND MEDIUM-SIZED TEARS OF THE ROTATOR CUFF
87
Table III. Scoring results for the two treatment groups at baseline, and at six and 12 months’ followup Outcome
Surgery group* (n = 52)
Physiotherapy group* (n = 51)
Constant score (range 0 to 100) Baseline 6 months 12 months
35.3 (31.6 to 39.0) 64.9 (60.2 to 69.7) 76.8 (72.6 to 80.9)
38.4 (34.4 to 42.4) 64.1 (58.5 to 69.7) 66.8 (60.6 to 73.1)
ASES† score (range 0 to 100) Baseline 6 months 12 months
45.5 (41.5 to 49.6) 84.5 (80.3 to 88.6) 92.6 (88.6 to 96.6)
48.2 (44.1 to 52.2) 75.8 (70.2 to 81.4) 79.2 (72.7 to 85.5)
Constant subscores Pain-free active abduction (°) Baseline 6 months 12 months
73.7 (65.9 to 81.5) 134.1 (122.4 to 145.9) 156.7 (146.8 to 166.8)
81.9 (73.5 to 90.3) 136.3 (123.2 to 149.5) 136.1 (122.5 to 149.7)
Pain-free active flexion (°) Baseline 6 months 12 months
86.8 (75.3 to 98.3) 145.9 (135.9 to 155.8) 164.3 (156.0 to 172.7)
88.6 (79.6 to 97.6) 147.3 (134.5 to 160.1) 148.8 (136.5 to 161.2)
Shoulder strength (kg) Baseline 6 months 12 months ASES subscore Shoulder pain on VAS‡ (cm) Baseline 6 months 12 months
7.5 (6.0 to 9.0) 7.9 (6.7 to 9.2) 11.0 (9.8 to 12.1)
8.1 (6.5 to 9.7) 10.6 (9.1 to 12.1) 11.4 (9.9 to 13.0)
5.6 (5.0 to 6.1) 1.2 (0.8 to 1.6) 0.6 (0.2 to 1.0)
5.3 (4.8 to 5.9) 2.6 (2.0 to 3.2) 2.1 (1.4 to 2.8)
* values are given as means, with the 95% confidence interals in parentheses † ASES, American Society of Shoulder and Elbow Surgeons ‡ VAS, visual analogue scale (0 to 10 cm)
study before treatment due to a sudden improvement of symptoms and his baseline results were carried on to all further analyses. The mean Constant score improved from baseline to 12 months by 41.4 points (SD 19.6) in the surgery group and 28.4 points (SD 21.9) in the physiotherapy group (Figure 2, Table III). The between-group difference of 13.0 points was statistically significant (95% confidence interval (CI) 4.9 to 21.1, p = 0.002). The mean ASES score improved by 47.1 points (SD 20.0) in the surgery group and 31.0 points (SD 20.2) in the physiotherapy group (Table III) with a statistically significant between-group difference of 16.1 points (95% CI 8.2 to 23.9, p < 0.0005). At six months, differences in improvement of the scores between groups reached significance only on the ASES scale (11.4 points, 95% CI 3.6 to 19.1, p = 0.005). Sub scores (Table III). Analysis of between-group differences showed a significantly larger increase of abduction in the surgery group by 28.8° (95% CI 10.1 to 47.5, p = 0.003) and a significantly larger reduction in pain by 1.7 on a VAS scale (95% CI -2.6 to -0.9, p < 0.0005). For shoulder VOL. 92-B, No. 1, JANUARY 2010
flexion, a trend for a larger increase in the surgery group was found (difference 17.3°, 95% CI -2.3 to 36.8, p = 0.08). For shoulder strength the between-group difference in improvement in the score was not significant (difference 0.2 kg, 95% CI -2.0 to 2.3, p = 0.89). General health score (Table IV). In both treatment groups, within-group differences from baseline to 12 months were largest for the component scales, with the highest validity for physical health (physical function, physical role, bodily pain) and the physical component summary score, but between-group differences did not reach significance (p-values ranging from 0.10 to 0.84). For the component scales with moderate (general health, vitality) and high validity for mental health (mental health scale) and the mental component summary score, within-group increases were small and between-group differences were not significant (p-values ranging from 0.29 to 0.92). Emotional role, a component score strongly related to mental health, showed a substantial baseline difference between groups. This finding was interpreted as coincidental, and as a consequence was not followed up further.
88
S. MOOSMAYER, G. LUND, U. SELJOM, I. SVEGE, T. HENNIG, R. TARIQ, H.-J. SMITH
Table IV. Results from the Short Form 36 Health Survey (SF-36) for the two treatment groups at baseline, and at six and 12 months’ follow-up Outcome
Surgery group* (n = 52)
Physiotherapy group* (n = 51)
Physical functioning Baseline 6 months 12 months
73.5 (70.5 to 76.4) 85.4 (81.6 to 89.2) 86.4 (81.7 to 91.2)
72.7 (68.2 to 77.3) 84.1 (80.0 to 88.2) 85.2 (80.4 to 90.0)
Role physical Baseline 6 months 12 months
20.2 (11.7 to 28.7) 54.8 (44.1 to 65.5) 72.6 (61.7 to 83.5)
27.9 (17.4 to 38.5) 60.3 (48.6 to 72.0) 65.2 (53.8 to 76.6)
Bodily pain Baseline 6 months 12 months
41.2 (36.8 to 45.5) 71.9 (65.9 to 78.0) 78.1 (71.1 to 85.2)
42.8 (37.0 to 48.6) 65.3 (58.9 to 71.6) 72.4 (65.5 to 79.6)
General health Baseline 6 months 12 months
74.6 (69.6 to 79.6) 78.5 (73.0 to 84.1) 79.1 (73.7 to 84.5)
72.6 (67.2 to 78.0) 80.1 (75.2 to 84.9) 78.7 (72.9 to 84.5)
Vitality Baseline 6 months 12 months
58.2 (51.2 to 65.2) 71.9 (65.8 to 78.0) 71.1 (65.2 to 77.0)
61.4 (54.6 to 68.1) 71.8 (65.9 to 77.6) 73.5 (67.9 to 79.1)
Social functioning Baseline 6 months 12 months
84.1 (78.2 to 90.1) 92.8 (89.2 to 96.4) 93.0 (89.0 to 97.1)
83.1 (75.9 to 90.3) 92.4 (88.4 to 96.4) 92.4 (88.3 to 96.6)
Role emotional Baseline 6 months 12 months
65.4 (53.5 to 77.3) 88.5 (80.9 to 96.0) 87.2 (78.9 to 95.4)
86.3 (77.9 to 94.7) 86.3 (78.5 to 94.0) 88.2 (80.3 to 96.2)
Mental health Baseline 6 months 12 months
83.2 (78.6 to 87.9) 88.2 (84.0 to 92.5) 88.1 (84.2 to 91.9)
84.5 (80.3 to 88.8) 89.3 (86.4 to 92.1) 89.0 (85.9 to 92.2)
Physical component summary score Baseline 6 months 12 months
38.2 (36.6 to 39.9) 47.9 (45.3 to 50.4) 50.7 (47.8 to 53.6)
38.6 (36.2 to 41.1) 47.3 (44.7 to 50.0) 48.9 (46.0 to 51.7)
54.1 (50.9 to 57.3) 57.5 (55.0 to 60.0) 56.2 (53.7 to 58.8)
57.3 (54.7 to 59.9) 57.6 (55.5 to 59.7) 57.5 (55.4 to 59.5)
Mental component summary score Baseline 6 months 12 months
* values are given as means, with the 95% confidence intervals in parentheses
Patient satisfaction. Mean values for patient satisfaction after
12 months as measured on a VAS scale (0 = very unsatisfied, 10 = very satisfied) were 9.0 (1.0 to 10.0) for the surgery group and 7.2 (0.0 to 10.0) for the physiotherapy group. Comparison of the results using a Mann-Whitney U test showed significance for the between-groups difference with p < 0.0005. Secondary surgery group (Table I). The patients derived insufficient benefit from physiotherapy as reflected by small
changes of score from baseline to the pre-operative measurements (mean change in Constant score -0.3 points (SD 13.0), and ASES score 6.8 points (SD 12.9)). After secondary surgery, the mean Constant scores increased by 33.9 points (SD 19.7), which is less than that achieved in the primary surgery group (41.4 points). On the ASES scale, the corresponding mean increase was 40.0 points (SD 25.2) compared to an interval of 47.1 points in the primary surgery group. THE JOURNAL OF BONE AND JOINT SURGERY
COMPARISON BETWEEN SURGERY AND PHYSIOTHERAPY IN THE TREATMENT OF SMALL AND MEDIUM-SIZED TEARS OF THE ROTATOR CUFF
Discussion In the treatment of small and medium-sized tears of the rotator cuff, although the effect of physiotherapy or tendon repair has been demonstrated in case studies, comparison studies are lacking.35,36 In studies that used the Constant score, the mean improvement ranged from 13.2 to 30.0 points for physiotherapy8,37-39 and from 24.0 to 43.1 points after open40-42 or arthroscopic43-47 tendon repair. Comparison between such studies and our findings is difficult because of differences in study design and patient selection. In the treatment of these patients the superiority of physiotherapy or surgical repair should be established by randomised studies comparing the two approaches. In our study, there was an improvement in the mean Constant score in both groups, but the change of score was 13.0 points larger in the surgery group (Fig. 2). The validity of this result was supported by the finding of a significantly better treatment effect in the surgery group on the ASES scale and by the subscores for shoulder abduction, pain and patient satisfaction. In agreement with other studies, we believe that a between-groups difference of 13.0 points on the Constant scale is not only statistically significant but also clinically relevant.32-34 In our study surgical treatment and physiotherapy were given on the basis of defined treatment protocols. However, as rotator cuff tears are not uniform, therapeutic approaches have to be adapted to the individual characteristics of the tear. Depending on the location of a tear, its size and the condition of the long head of the biceps tendon, surgery was performed by a mini-open instead of an open approach whenever possible, and a tenodesis of the long head of biceps carried out when the tendon was found to be pathological. This reflects accepted surgical standards. In the same way, physiotherapy had to be tailored individually. Before the study, a pool of therapeutic measures was defined, but the selection of exercises, the number of repetitions and the VOL. 92-B, No. 1, JANUARY 2010
90 80 Constant points
Assessment of tendon repair by MRI. Assessment of the integrity of the tendon 12 months after surgical repair was possible in 50 of 51 patients in the primary surgery group (one patient had artificial heart valves) and in all nine patients of the secondary surgery group. In the primary surgery group MRI diagnosed an intact rotator cuff in 38 cases (76%), a partialthickness tear in six cases (12%) and a full-thickness tear in four (8%). In two cases (4%) assessment of the tendon was not conclusive because of artefacts. In the secondary surgery group, eight of nine tendons were intact and there was a further full-thickness tear in one. Unexpected events. Three months post-operatively one patient in the surgery group sustained a traumatic fracture of the proximal humerus. This was treated in a sling, and routine MRI at 12 months’ follow-up showed an intact tendon repair. One patient from the physiotherapy group was diagnosed with polymyalgia rheumatica four months after inclusion and was treated with steroids. Both patients remained in the study and outcome was assessed as randomised.
89
70 60 50
Surgery group Physiotherapy group
40 30 Baseline
6 mths
12 mths
Time Fig. 2 Plot showing mean Constant scores (with 95% confidence intervals) at baseline and at six and 12 months for the surgery group (closed triangles) and the physiotherapy group (closed rectangles).
duration of treatment was individually adjusted according to the clinical findings and the responses to treatment as has been described for the treatment of these patients.17-19 In order to avoid interpretation bias and loss of power it was decided to perform all outcome analyses ‘as randomised’ by following an intention-to-treat principle. As a consequence, results from patients who withdrew (one from the surgery group) and those who changed treatment (nine from the physiotherapy group) were assessed as originally randomised. For the patient who withdrew from the surgery group, the baseline data carried forward gave him a result far below the mean of his group. The nine patients who changed treatment after failed physiotherapy had all performed at least 15 treatment sessions, and it seemed adequate to interpret their final score pre-operatively as the best estimate for the final result from physiotherapy. Following these patients without further treatment would have been unethical, and elimination of their results from analysis would have led to an overestimation of the effect of physiotherapy. As shown in Table III, there are small, non-significant baseline differences between the groups (a mean difference in the Constant score: 3.1 points, p = 0.26, differences in the mean ASES score: 2.7 points, p = 0.36). Following the as randomised principle, no baseline correction was performed at analysis. The inclusion of a correction for baseline differences would have reduced the between-groups differences by their baseline differences, but p-values for between-groups differences would still have been significant on the Constant (p = 0.009) and on the ASES scores (p = 0.001). Tendon repair should be performed prior to the development of tendon retraction and muscle atrophy. A period of failed physiotherapy will delay surgical treatment and may influence the result of secondary surgery. The mean operative delay in our secondary surgery group compared to the
90
S. MOOSMAYER, G. LUND, U. SELJOM, I. SVEGE, T. HENNIG, R. TARIQ, H.-J. SMITH
primary group was five months, and treatment benefit, as expressed by the mean Constant score, was 7.5 points below the result from the primary surgery group. Interpretation of this difference in outcomes, however, is difficult because of the small sample size in the secondary surgery group. The intention of this study was to compare treatment effects from surgical treatment and physiotherapy. By carrying forward the last outcome result prior to secondary surgery as the final result for patients with failed physiotherapy, our analysis considered physiotherapy as an isolated treatment regimen. In clinical practice, however, physiotherapy will be offered together with secondary surgery as a rescue procedure for patients who fail conservative treatment. The final result in the nine patients with failed physiotherapy is the 12-month result after secondary surgery. Replacing the results that were carried forward by those of secondary surgery in these nine patients, and excluding the result of the patient who withdrew from the surgical group before treatment, would have reduced the difference between groups on the Constant scale from 13.0 to 7.7 points (95% CI 0.39 to 15.1, p = 0.04). This size of difference may be considered as of small relevance clinically. Together with the large number of patients (42 of 51, 82%) who accepted the result achieved by physiotherapy as their final result, this may support physiotherapy as an initial option for small and medium-sized rotator cuff tears. However, by this way of analysis, surgery is no longer compared with physiotherapy but with the results of physiotherapy combined with secondary surgery for those with insufficient response to physiotherapy. A limitation of this study is the follow-up period of only one year. In particular, the consistency of our results after non-operative treatment may be questioned.6,7 Tears that are not repaired may enlarge, become more symptomatic and be more difficult to treat. Further follow-up is necessary and is underway. In this study larger treatment benefits in terms of outcome scores after one year were found for surgical treatment of rotator cuff tears compared to physiotherapy. Differences with statistical and clinical significance were demonstrated on different scoring instruments. At the same time, 42 of 51 non-surgically treated patients accepted the result from physiotherapy as their final treatment result, and nine patients with insufficient effect from physiotherapy were treated effectively by secondary surgery. In the short term, both approaches can be considered in the treatment of patients with small and medium-sized rotator cuff tears but better results can be expected after primary surgical repair. The authors would like to thank Mr B. Haldorson, Department of Physiotherapy for his role in conservative treatment and Drs N. Kise and K. Nerhus for their help in the surgical management. Although none of the authors has received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article, benefits have been or will be received but will be directed solely to a research fund, foundation, educational institution, or other nonprofit organisation with which one or more of the authors are associated.
References 1. Habermeyer P, Brunner U, Wiedemann E. Reconstructive surgery for massive rotator cuff tear. Orthop Traumatol 1992;2:210-26. 2. Iannotti JP, Bernot MP, Kuhlman JR, Kelley MJ, Williams GR. Postoperative assessment of shoulder function: a prospective study of full-thickness rotator cuff tears. J Shoulder Elbow Surg 1996;5:449-57. 3. Romeo AA, Hang DW, Bach BR, Shott S. Repair of full thickness rotator cuff tears: gender, age and other factors affecting outcome. Clin Orthop 1999;367:24355. 4. Rokito AS, Cuomo F, Gallagher MA, Zuckerman JD. Long-term functional outcome of repair of large and massive chronic tears of the rotator cuff. J Bone Joint Surg [Am] 1999;81-A:991-7. 5. Cofield RH, Parvizi J, Hoffmeyer PJ, et al. Surgical repair of chronic rotator cuff tears: a prospective long-term study. J Bone Joint Surg [Am] 2001;83-A:71-7. 6. Itoi E, Tabata S. Conservative treatment of rotator cuff tears. Clin Orthop 1992;275:165-73. 7. Goldberg BA, Nowinski RJ, Matsen FA. Outcome of nonoperative management of full-thickness rotator cuff tears. Clin Orthop 2001;382:99-107. 8. Koubâa S, Ben Salah FZ, Lebib S, Miri I, Ghorbel S. Conservative management of full-thickness rotator cuff tears: a prospective study of 24 patients. Ann Readapt Med Phys 2006;49:62-7 (in French). 9. Bokor DJ, Hawkins RJ, Huckell GH, Angelo RL, Schickendantz MS. Results of nonoperative management of full-thickness tears of the rotator cuff. Clin Orthop 1993;294:103-10. 10. Bartolozzi A, Andreychik D, Ahmad S. Determinants of outcome in the treatment of rotator cuff disease. Clin Orthop 1994;308:90-7. 11. Wirth MA, Basamania C, Rockwood CA. Nonoperative management of fullthickness tears of the rotator cuff. Orthop Clin North Am 1997;28:59-67. 12. Constant CR, Murley AHG. A clinical method of functional assessment of the shoulder. Clin Orthop 1987;214:160-4. 13. Richards RR, An KN, Bigliani LU, et al. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg 1994;3:347-52. 14. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). 1. Conceptual framework and item selection. MedCare 1992;30:473-83. 15. Thomazeau H, Rolland Y, Lucas C, Duval JM, Langlais F. Atrophy of the supraspinatus belly: assessment by MRI in 55 patients with rotator cuff pathology. Acta Orthop Scand 1996;67:264-8. 16. Neer CS. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg [Am] 1972;54-A:41-50. 17. Mottram SL. Dynamic stability of the scapula. Man Ther 1997;2:123-31. 18. Hess SA. Functional stability of the glenohumeral joint. Man Ther 2000;5:63-71. 19. Magarey ME, Jones MA. Dynamic evaluation and early management of altered motor control around the shoulder complex. Man Ther 2003;8:195-206. 20. Owen RS, Iannotti JP, Kneeland JB, et al. Shoulder after surgery: MR imaging with surgical validation. Radiology 1993;186:443-7. 21. Magee TH, Gaenslen ES, Seitz R, Hinson GA, Wetzel LH. MR imaging for the shoulder after surgery. AJR Am J Roentgenol 1996;168:925-8. 22. Gaenslen ES, Satterlee CG, Hinson GW. Magnetic resonance imaging for evaluation of failed repairs of the rotator cuff. J Bone Joint Surg [Am] 1996;78-A:13916. 23. Zanetti M, Jost B, Hodler J, Gerber C. MR imaging after rotator cuff repair: fullthickness defects and bursitis-like subacromial abnormalities in asymptomatic subjects. Skeletal Radiol 2000;29:314-19. 24. Conboy VB, Morris RW, Kiss J, Carr AJ. An evaluation of the Constant-Murley shoulder assessment. J Bone Joint Surg [Br] 1996;78-B:229-32. 25. Michener LA, McClure PW, Sennett BJ. American shoulder and elbow surgeons standardized shoulder assessment form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg 2002;11:587-94. 26. McHorney CA, Ware JE, Raczek AE. The MOS 36-item short-form health survey (SF-36). II: psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 1993;31:247-63. 27. Beaton DE, Richards RR. Measuring function of the shoulder: a cross-sectional comparison of five questionnaires. J Bone Joint Surg [Am] 1996;78-A:882-90. 28. Gartsman GM, Brinker MR, Khan M, Karahan M. Self-assessment of general health status in patients with five common shoulder conditions. J Shoulder Elbow Surg 1998;7:228-37. 29. Beaton DE, Richards RR. Assessing the reliability and responsiveness of 5 shoulder questionnaires. J Shoulder Elbow Surg 1998;7:565-72. 30. Duckworth DG, Smith KL, Campbell B, Matsen FA. Self-assessment questionnaires document substantial variability in the clinical expression of rotator cuff tears. J Shoulder Elbow Surg 1999;8:330-3.
THE JOURNAL OF BONE AND JOINT SURGERY
COMPARISON BETWEEN SURGERY AND PHYSIOTHERAPY IN THE TREATMENT OF SMALL AND MEDIUM-SIZED TEARS OF THE ROTATOR CUFF
91
31. McKee MD, Yoo DJ. The effect of surgery for rotator cuff disease on general health status. J Bone Joint Surg [Am] 2000;82-A:970-9.
39. Ghroubi S, Chaari M, Elleuch H, et al. Functional and quality of life outcome of non-operated rotator cuff tears. Ann Readapt Med Phys 2008;51:714-21.
32. Haahr JP, Østergaard S, Dalsgaard J, et al. Exercises versus arthroscopic decompression in patients with subacromial impingement: a randomised, controlled study in 90 cases with a one year follow up. Ann Rheum Dis 2005;64:760-4.
40. Gazielly DF, Gleyze P, Montagnon C. Functional and anatomical results after rotator cuff repair. Clin Orthop 1994;304:43-53.
33. Hodgson SA, Mawson SJ, Stanley D. Rehabilitation after two-part fractures of the neck of the humerus. J Bone Joint Surg [Br] 2003;85-B:419-22. 34. Lefevre-Coleau MM, Babinet A, Fayad F, et al. Immediate mobilization compared with conventional immobilization for the impacted nonoperatively treated proximal humeral fracture: a randomised controlled trial. J Bone Joint Surg [Am] 2007;89-A:2582-90. 35. Einisman B, Andreoli CV, Soares BGO, Fallopa F, Peccin MS. Interventions for tears of the rotator cuff in adults. The Cochrane Database of Systematic Reviews 2004;pCD12758. 36. Grant J, Arthur A, Pichora DR. Evaluation of interventions for rotator cuff pathology: a systematic review. J Hand Ther 2004;17:274-99.
41. Klepps S, Bishop J, Lin J, Cahlon O, Strauss A. Prospective evaluation of the effect of rotator cuff integrity on the outcome of open rotator cuff repairs. Am J Sports Med 2004;32:1716-22. 42. Fuchs B, Gilbart MK, Hodler J, Gerber C. Clinical and structural results of open repair of an isolated one-tendon tear of the rotator cuff. J Bone Joint Surg [Am] 2006;88-A:309-16. 43. Gartsman GM, Khan M, Hammerman SM. Arthroscopic repair of full-thickness tears of the rotator cuff. J Bone Joint Surg [Am] 1998;80-A:832-40. 44. Boileau P, Brassart N, Watkinson DJ, et al. Arthroscopic repair of full-thickness tears of the supraspinatus: does the tendon really heal? J Bone Joint Surg [Am] 2005;87-A:1229-40. 45. Huijsmans PE, Pritchard MP, Berghs BM, et al. Arthroscopic rotator cuff repair with double-row fixation. J Bone Joint Surg [Am] 2007;89-A:1248-57.
37. Baydar M, Akalin E, Ozlem E, et al. The efficacy of conservative treatment in patients with full-thickness rotator cuff tears. Rheumatol Int 2009;29:623-8.
46. Lafosse L, Brozska R, Toussaint B, Gobezie R. The outcome and structural integrity of arthroscopic rotator cuff repair with use of the double-row suture anchor technique. J Bone Joint Surg [Am] 2007;89-A:1533-41.
38. Heers G, Anders S, Werther M, et al. Efficacy of home exercises for symptomatic rotator cuff tears in correlations to the size of the defect. Sportverletz Sportschaden 2005;19:22-7 (in German).
47. Levy O, Venkateswaran B, Even T, Ravenscroft M, Copeland S. Mid-term clinical and sonographic outcome of arthroscopic repair of the rotator cuff. J Bone Joint Surg [Br] 2008;90-B:1341-7.
VOL. 92-B, No. 1, JANUARY 2010