1504 C OPYRIGHT 2014
BY
T HE J OURNAL
OF
B ONE
AND J OINT
S URGERY, I NCORPORATED
Tendon Repair Compared with Physiotherapy in the Treatment of Rotator Cuff Tears A Randomized Controlled Study in 103 Cases with a Five-Year Follow-up Stefan Moosmayer, MD, PhD, Gerty Lund, PT, Unni S. Seljom, PT, Benjamin Haldorsen, PT, Ida C. Svege, PT, Toril Hennig, OT, Are H. Pripp, PhD, and Hans-Jørgen Smith, MD, PhD Investigation performed at the Departments of Orthopaedic Surgery and Physiotherapy, Martina Hansens Hospital, Sandvika, Norway
Background: There is limited Level-I evidence that compares operative and nonoperative treatment of rotator cuff tears. We compared outcomes of patients treated with primary tendon repair with outcomes of those treated with physiotherapy and optional secondary tendon repair if needed. Methods: A single-center, pragmatic, randomized controlled study with follow-ups after six months and one, two, and five years was conducted in a secondary-care institution. One hundred and three patients with a rotator cuff tear not exceeding 3 cm were randomized to primary tendon repair (n = 52) or physiotherapy (n = 51). The primary outcome measure was the Constant score. Secondary outcome measures included the self-report section of the American Shoulder and Elbow Surgeons score; the physical component summary measure of the Short Form 36 Health Survey; the measurement of pain, strength, and shoulder motion; patient satisfaction; and findings from magnetic resonance imaging and sonography. Analysis was by intention to treat. Results: The five-year follow-up rate was 98%. Twelve of the fifty-one patients in the physiotherapy group were treated with secondary tendon repair. The results from primary tendon repair were superior to those from physiotherapy plus secondary repair, with between-group mean differences of 5.3 points on the Constant score (p = 0.05), 9.0 points on the American Shoulder and Elbow Surgeons score (p < 0.001), 1.1 cm on a 10-cm visual analog scale for pain (p < 0.001), and 1.0 cm on a 10-cm visual analog scale for patient satisfaction (p = 0.03). In 37% of tears treated with physiotherapy only, there were increasing tear sizes on ultrasound of >5 mm, over five years, associated with an inferior outcome. Conclusions: Although primary repair of small and medium-sized rotator cuff tears was associated with better outcome than physiotherapy treatment, the differences were small and may be below clinical importance. In the physiotherapy treatment group, there were increasing tear sizes and inferior outcomes in one-third of patients who did not undergo repair. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Peer Review: This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.
Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. None of the authors, or their institution(s), have had any financial relationship, in the thirty-six months prior to submission of this work, with any entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, no author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.
J Bone Joint Surg Am. 2014;96:1504-14
d
http://dx.doi.org/10.2106/JBJS.M.01393
A commentary by John E. Kuhn, MD, MS, is linked to the online version of this article at jbjs.org.
1505 TH E JO U R NA L O F B O N E & JO I N T SU RG E RY J B J S . O RG V O L U M E 96-A N U M B E R 18 S E P T E M B E R 17, 2 014 d
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A
ppropriate treatment selection for rotator cuff tears has been debated. Tendon repair and physiotherapy are common treatment options. Treatment effect has been reported for both methods in case studies1-13. Comparison studies are lacking, and it is unclear if clinical results differ between methods. Although beneficial for most patients, both treatments have possible side effects. Surgical results may be affected by postoperative shoulder stiffness, infection, or nonhealing of the repair. Physiotherapy leaves tears unrepaired, and studies of the natural course of such tears have often shown clinical and anatomical deterioration over time, with some primarily repairable tears progressing to an unrepairable tear14-17. Despite a lack of evidence supporting the superiority of either physiotherapy or tendon repair, a trend toward surgical repair has been reported. Two recent studies have shown an increasing number of rotator cuff surgical procedures performed per visit for shoulder pain18 and an increase in the population incidence of rotator cuff repairs over the last decade by 238%19. The purpose of the present study was to compare treatment outcomes of primary tendon repair with those of a physiotherapy program, which included the possibility for crossing over to secondary tendon repair for patients with persistent symptoms. The one-year results of the same cohort were previously reported20. The hypothesis was that a substantial number of patients in the physiotherapy group would have secondary tendon repair and that analysis by intention to treat would show comparable treatment benefits in the two study groups. Materials and Methods Patients and Procedures
T
he study was performed in one Norwegian secondary care institution as a pragmatic, randomized, controlled clinical trial with five-year follow-up. It was approved by our institution’s ethics committee (reference number 43004149) and was registered at ClinicalTrials.gov (NCT00852657). Written informed consent was obtained from all participants prior to randomization. From September 2004 to October 2007, 281 patients from the Oslo region, deemed by their general practitioners to have a rotator cuff lesion and referred to our hospital for further management, were assessed clinically, with ultrasound examination, and by magnetic resonance imaging (MRI) for study inclusion. The clinical inclusion criteria were pain at rest or exercise laterally on 21 22,23 the shoulder; a painful motion arc ; a positive impingement sign ; passive shoulder motion of at least 140 for abduction and flexion; demonstration of a full-thickness tear of the rotator cuff by both sonography and MRI, with a tear size not exceeding 3 cm on sonography; and muscle atrophy not exceeding stage 2 24 on MRI . Acute tears (after substantial trauma in an earlier asymptomatic shoulder), acute-on-chronic tears (after a traumatic event in a shoulder with preceding episodes of symptoms), and chronic (atraumatic) tears were included. Exclusion criteria were patient age of less than eighteen years, tears involving more than 25% of the width of the subscapularis tendon, the presence of other local or systemic diseases affecting shoulder function, a history of surgical treatment of the involved shoulder, a medical contraindication for surgery or anesthesia, and an inability to understand written and spoken Norwegian.
Outcome Measures Patients were evaluated at baseline and at six months and one, two, and five years by an assessor (T.H.) blinded for treatment allocations. The five-year follow-up was the time point of primary interest. The Constant score was the primary outcome measure and was selected because of its widespread use in 25 rotator cuff research and its specific subscale for shoulder strength . Secondary outcome measures included the self-report section of the American
T E N D O N R E PA I R C O M PA R E D W I T H P H Y S I O T H E R A P Y I N T H E T R E AT M E N T O F R O TAT O R C U F F T E A R S
26
Shoulder and Elbow Surgeons (ASES) score , the physical component 27 summary measure of the Short Form 36 Health Survey (SF-36) , and the measurement of pain, strength, and pain-free mobility of the shoulder. After five years, the question ‘‘Are you satisfied with your treatment result?’’ was answered on a 10-cm visual analog scale (VAS) on which the answers ranged 28 from ‘‘very dissatisfied’’ to ‘‘extremely satisfied’’ . At the one-year follow-up, surgical patients were re-examined by MRI. After five years, all patients were re-examined by ultrasound with the sonographer blinded for baseline results. Standardized examination protocols and diagnostic criteria for the imaging 20,29 techniques were followed as presented earlier .
Randomization and Blinding An external investigator with no clinical involvement in the trial generated the randomization list prior to study start. The randomization sequence was concealed from the study’s collaborators until interventions were assigned. Block randomization (block length of 20 and a one-to-one ratio) was used to achieve balance between treatment groups. Sequentially numbered, sealed, opaque envelopes were used to assign treatment allocation according to the participants’ study number, which was given at baseline assessment. Assignment occurred after baseline assessment was completed. The outcome assessor (T.H.) remained blinded to the allocation throughout the whole study.
Surgical Procedure and Postoperative Management Tendon repair was performed in a standardized manner by an open approach (forty-two cases) or, if possible, by a mini-open approach (nine cases); one case did not receive the allocated intervention. All patients underwent procedures performed by one of three experienced orthopaedic surgeons, one of whom (S.M.) was an author of this study. Surgery was performed with the patient in the beach-chair position and consisted of diagnostic arthroscopy of the glenohumeral joint, a deltoid-splitting approach for tear exposure, an acromioplasty, mobilization of the torn tendons until full coverage of the footprint was achieved, tendon repair by a modified Mason-Allen technique (two to four sets of nonabsorbable sutures, depending on tear size), and repair of the detached part of the deltoid to the acromion through bone tunnels. In eighteen cases in the primary tendon repair group in which arthroscopy showed a partial tear of the long head of the biceps tendon, a tenodesis was performed. A detailed description of the 20 surgical procedure was reported previously . Postoperatively, the arm was immobilized in a shoulder sling and passive range-of-motion exercises were started on the first postoperative day and continued for six weeks. After hospital discharge, patients were referred for supervised physiotherapy supplemented by home exercises. Active-assisted motions were started six weeks after surgery, with strengthening exercises initiated twelve weeks after the surgery.
Physiotherapy Physiotherapy was given as an outpatient treatment at our hospital by one of four physiotherapists experienced in conservative shoulder management (G.L., U.S.S., B.H., and I.C.S.). A rehabilitation program, based on literature supporting the effectiveness of individualized physiotherapy for rotator 30-32 cuff tears , was scheduled prior to the study. The program consisted of fiftytwo different exercises. All exercises were photographed and have been published 33 together with an explanatory text . The selection of exercises was individually tailored according to examination findings and treatment progress. Particular attention was directed toward the correction of upper body posture and the restoration of scapulothoracic and glenohumeral muscular control and stability. Exercises were supplemented by patient education for a better understanding of shoulder function and treatment principles. Primary treatment goals were the correction of scapula malpositioning at rest and the restoration of ideal scapula positioning and centering of the humeral head during movement. A selection of the most 33 central exercises of the program is given in the Appendix. Treatment sessions of forty minutes were given twice weekly for twelve weeks, with increasing intervals during the following six to twelve weeks. Exercises that the patient had learned to master correctly were given as home exercises, but only one or two at a time. No supplementary treatment, such as cortisone injections or pain medication, was given.
1506 TH E JO U R NA L O F B O N E & JO I N T SU RG E RY J B J S . O RG V O L U M E 96-A N U M B E R 18 S E P T E M B E R 17, 2 014 d
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T E N D O N R E PA I R C O M PA R E D W I T H P H Y S I O T H E R A P Y I N T H E T R E AT M E N T O F R O TAT O R C U F F T E A R S
Fig. 1
A Consolidated Standards of Reporting Trials (CONSORT) flowchart of the trial enrollment and analysis. Patients with missing values due to non-attendance and the two deceased patients were included in the mixed model analyses with incomplete data sets.
Secondary Surgery The decision to offer secondary surgery after a minimum of fifteen physiotherapeutic treatment sessions was based on the non-acceptance of the achieved result by the patient and the persistence of clinical findings at examination.
Statistical Analysis It was determined that to detect a 12-point difference with the Constant score with a power of 0.8, a significance level of 0.05, and an anticipated standard deviation of 20 points, forty-five patients were needed in each treatment arm. To compensate for expected losses to follow-up, 103 patients were included in the study. Raw data as shown in Table I were compared between groups. Analysis was performed by intention to treat, that is, all patients were analyzed in the group to which they were originally allocated. A linear mixed model for repeated measurements was used for analysis. The time of follow-up (as a categorical variable) and the choice of treatment were included in the model as explanatory factors, and a random intercept was incorporated. All main group analyses were performed adjusted for baseline differences of the respective dependent variable and age. For variables showing a significant interaction term between time and treatment (indicating a significant difference of time profiles between groups during follow-up, i.e., effect modification), between-group mean differences were estimated separately for each time of follow-up using regression analysis. For variables with a non-
significant interaction term between time and treatment, together with a significant finding for the main effect of treatment (indicating a constant between-group difference during follow-up), the model was recalculated with no interaction term included. No adjustment for multiple comparisons was considered to be necessary. Analyses of subgroups, based on the anatomic outcome (tear size increase, re-tears) and on the treatment that was given (post hoc as treated), was performed by mixed model analysis with no adjustment for baseline differences. Investigation of differences in patient satisfaction between groups was performed with an independent samples t test.
Source of Funding In support of the research for this manuscript, outside funding was given by the South-Eastern Norway Regional Health Authority. Funds were used to pay for salaries. The source of funding did not play a role in the investigation.
Results ne hundred and three patients met our criteria for inclusion and were randomly assigned to surgical treatment (n = 52) or physiotherapy (n = 51) (Fig. 1)34. The five-year follow-up rate was 98%. Demographic data (Table II) and study scores at enrollment (Table I) were comparable between the two treatment
O
1507 TH E JO U R NA L O F B O N E & JO I N T SU RG E RY J B J S . O RG V O L U M E 96-A N U M B E R 18 S E P T E M B E R 17, 2 014 d
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T E N D O N R E PA I R C O M PA R E D W I T H P H Y S I O T H E R A P Y I N T H E T R E AT M E N T O F R O TAT O R C U F F T E A R S
TABLE I Results of Primary and Secondary Outcome Measures
Outcome Measures
Primary Tendon Repair*†
Physiotherapy with Optional Secondary Repair*†
Between-Group Difference‡§
Main Effect#
Treatment · Time Interaction**
0.05
0.20
BY
T HE J OURNAL
OF
B ONE
AND J OINT
S URGERY, I NCORPORATED
Tendon Repair Compared with Physiotherapy in the Treatment of Rotator Cuff Tears A Randomized Controlled Study in 103 Cases with a Five-Year Follow-up Stefan Moosmayer, MD, PhD, Gerty Lund, PT, Unni S. Seljom, PT, Benjamin Haldorsen, PT, Ida C. Svege, PT, Toril Hennig, OT, Are H. Pripp, PhD, and Hans-Jørgen Smith, MD, PhD Investigation performed at the Departments of Orthopaedic Surgery and Physiotherapy, Martina Hansens Hospital, Sandvika, Norway
Background: There is limited Level-I evidence that compares operative and nonoperative treatment of rotator cuff tears. We compared outcomes of patients treated with primary tendon repair with outcomes of those treated with physiotherapy and optional secondary tendon repair if needed. Methods: A single-center, pragmatic, randomized controlled study with follow-ups after six months and one, two, and five years was conducted in a secondary-care institution. One hundred and three patients with a rotator cuff tear not exceeding 3 cm were randomized to primary tendon repair (n = 52) or physiotherapy (n = 51). The primary outcome measure was the Constant score. Secondary outcome measures included the self-report section of the American Shoulder and Elbow Surgeons score; the physical component summary measure of the Short Form 36 Health Survey; the measurement of pain, strength, and shoulder motion; patient satisfaction; and findings from magnetic resonance imaging and sonography. Analysis was by intention to treat. Results: The five-year follow-up rate was 98%. Twelve of the fifty-one patients in the physiotherapy group were treated with secondary tendon repair. The results from primary tendon repair were superior to those from physiotherapy plus secondary repair, with between-group mean differences of 5.3 points on the Constant score (p = 0.05), 9.0 points on the American Shoulder and Elbow Surgeons score (p < 0.001), 1.1 cm on a 10-cm visual analog scale for pain (p < 0.001), and 1.0 cm on a 10-cm visual analog scale for patient satisfaction (p = 0.03). In 37% of tears treated with physiotherapy only, there were increasing tear sizes on ultrasound of >5 mm, over five years, associated with an inferior outcome. Conclusions: Although primary repair of small and medium-sized rotator cuff tears was associated with better outcome than physiotherapy treatment, the differences were small and may be below clinical importance. In the physiotherapy treatment group, there were increasing tear sizes and inferior outcomes in one-third of patients who did not undergo repair. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Peer Review: This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.
Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. None of the authors, or their institution(s), have had any financial relationship, in the thirty-six months prior to submission of this work, with any entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, no author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.
J Bone Joint Surg Am. 2014;96:1504-14
d
http://dx.doi.org/10.2106/JBJS.M.01393
A commentary by John E. Kuhn, MD, MS, is linked to the online version of this article at jbjs.org.
1505 TH E JO U R NA L O F B O N E & JO I N T SU RG E RY J B J S . O RG V O L U M E 96-A N U M B E R 18 S E P T E M B E R 17, 2 014 d
d
d
A
ppropriate treatment selection for rotator cuff tears has been debated. Tendon repair and physiotherapy are common treatment options. Treatment effect has been reported for both methods in case studies1-13. Comparison studies are lacking, and it is unclear if clinical results differ between methods. Although beneficial for most patients, both treatments have possible side effects. Surgical results may be affected by postoperative shoulder stiffness, infection, or nonhealing of the repair. Physiotherapy leaves tears unrepaired, and studies of the natural course of such tears have often shown clinical and anatomical deterioration over time, with some primarily repairable tears progressing to an unrepairable tear14-17. Despite a lack of evidence supporting the superiority of either physiotherapy or tendon repair, a trend toward surgical repair has been reported. Two recent studies have shown an increasing number of rotator cuff surgical procedures performed per visit for shoulder pain18 and an increase in the population incidence of rotator cuff repairs over the last decade by 238%19. The purpose of the present study was to compare treatment outcomes of primary tendon repair with those of a physiotherapy program, which included the possibility for crossing over to secondary tendon repair for patients with persistent symptoms. The one-year results of the same cohort were previously reported20. The hypothesis was that a substantial number of patients in the physiotherapy group would have secondary tendon repair and that analysis by intention to treat would show comparable treatment benefits in the two study groups. Materials and Methods Patients and Procedures
T
he study was performed in one Norwegian secondary care institution as a pragmatic, randomized, controlled clinical trial with five-year follow-up. It was approved by our institution’s ethics committee (reference number 43004149) and was registered at ClinicalTrials.gov (NCT00852657). Written informed consent was obtained from all participants prior to randomization. From September 2004 to October 2007, 281 patients from the Oslo region, deemed by their general practitioners to have a rotator cuff lesion and referred to our hospital for further management, were assessed clinically, with ultrasound examination, and by magnetic resonance imaging (MRI) for study inclusion. The clinical inclusion criteria were pain at rest or exercise laterally on 21 22,23 the shoulder; a painful motion arc ; a positive impingement sign ; passive shoulder motion of at least 140 for abduction and flexion; demonstration of a full-thickness tear of the rotator cuff by both sonography and MRI, with a tear size not exceeding 3 cm on sonography; and muscle atrophy not exceeding stage 2 24 on MRI . Acute tears (after substantial trauma in an earlier asymptomatic shoulder), acute-on-chronic tears (after a traumatic event in a shoulder with preceding episodes of symptoms), and chronic (atraumatic) tears were included. Exclusion criteria were patient age of less than eighteen years, tears involving more than 25% of the width of the subscapularis tendon, the presence of other local or systemic diseases affecting shoulder function, a history of surgical treatment of the involved shoulder, a medical contraindication for surgery or anesthesia, and an inability to understand written and spoken Norwegian.
Outcome Measures Patients were evaluated at baseline and at six months and one, two, and five years by an assessor (T.H.) blinded for treatment allocations. The five-year follow-up was the time point of primary interest. The Constant score was the primary outcome measure and was selected because of its widespread use in 25 rotator cuff research and its specific subscale for shoulder strength . Secondary outcome measures included the self-report section of the American
T E N D O N R E PA I R C O M PA R E D W I T H P H Y S I O T H E R A P Y I N T H E T R E AT M E N T O F R O TAT O R C U F F T E A R S
26
Shoulder and Elbow Surgeons (ASES) score , the physical component 27 summary measure of the Short Form 36 Health Survey (SF-36) , and the measurement of pain, strength, and pain-free mobility of the shoulder. After five years, the question ‘‘Are you satisfied with your treatment result?’’ was answered on a 10-cm visual analog scale (VAS) on which the answers ranged 28 from ‘‘very dissatisfied’’ to ‘‘extremely satisfied’’ . At the one-year follow-up, surgical patients were re-examined by MRI. After five years, all patients were re-examined by ultrasound with the sonographer blinded for baseline results. Standardized examination protocols and diagnostic criteria for the imaging 20,29 techniques were followed as presented earlier .
Randomization and Blinding An external investigator with no clinical involvement in the trial generated the randomization list prior to study start. The randomization sequence was concealed from the study’s collaborators until interventions were assigned. Block randomization (block length of 20 and a one-to-one ratio) was used to achieve balance between treatment groups. Sequentially numbered, sealed, opaque envelopes were used to assign treatment allocation according to the participants’ study number, which was given at baseline assessment. Assignment occurred after baseline assessment was completed. The outcome assessor (T.H.) remained blinded to the allocation throughout the whole study.
Surgical Procedure and Postoperative Management Tendon repair was performed in a standardized manner by an open approach (forty-two cases) or, if possible, by a mini-open approach (nine cases); one case did not receive the allocated intervention. All patients underwent procedures performed by one of three experienced orthopaedic surgeons, one of whom (S.M.) was an author of this study. Surgery was performed with the patient in the beach-chair position and consisted of diagnostic arthroscopy of the glenohumeral joint, a deltoid-splitting approach for tear exposure, an acromioplasty, mobilization of the torn tendons until full coverage of the footprint was achieved, tendon repair by a modified Mason-Allen technique (two to four sets of nonabsorbable sutures, depending on tear size), and repair of the detached part of the deltoid to the acromion through bone tunnels. In eighteen cases in the primary tendon repair group in which arthroscopy showed a partial tear of the long head of the biceps tendon, a tenodesis was performed. A detailed description of the 20 surgical procedure was reported previously . Postoperatively, the arm was immobilized in a shoulder sling and passive range-of-motion exercises were started on the first postoperative day and continued for six weeks. After hospital discharge, patients were referred for supervised physiotherapy supplemented by home exercises. Active-assisted motions were started six weeks after surgery, with strengthening exercises initiated twelve weeks after the surgery.
Physiotherapy Physiotherapy was given as an outpatient treatment at our hospital by one of four physiotherapists experienced in conservative shoulder management (G.L., U.S.S., B.H., and I.C.S.). A rehabilitation program, based on literature supporting the effectiveness of individualized physiotherapy for rotator 30-32 cuff tears , was scheduled prior to the study. The program consisted of fiftytwo different exercises. All exercises were photographed and have been published 33 together with an explanatory text . The selection of exercises was individually tailored according to examination findings and treatment progress. Particular attention was directed toward the correction of upper body posture and the restoration of scapulothoracic and glenohumeral muscular control and stability. Exercises were supplemented by patient education for a better understanding of shoulder function and treatment principles. Primary treatment goals were the correction of scapula malpositioning at rest and the restoration of ideal scapula positioning and centering of the humeral head during movement. A selection of the most 33 central exercises of the program is given in the Appendix. Treatment sessions of forty minutes were given twice weekly for twelve weeks, with increasing intervals during the following six to twelve weeks. Exercises that the patient had learned to master correctly were given as home exercises, but only one or two at a time. No supplementary treatment, such as cortisone injections or pain medication, was given.
1506 TH E JO U R NA L O F B O N E & JO I N T SU RG E RY J B J S . O RG V O L U M E 96-A N U M B E R 18 S E P T E M B E R 17, 2 014 d
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T E N D O N R E PA I R C O M PA R E D W I T H P H Y S I O T H E R A P Y I N T H E T R E AT M E N T O F R O TAT O R C U F F T E A R S
Fig. 1
A Consolidated Standards of Reporting Trials (CONSORT) flowchart of the trial enrollment and analysis. Patients with missing values due to non-attendance and the two deceased patients were included in the mixed model analyses with incomplete data sets.
Secondary Surgery The decision to offer secondary surgery after a minimum of fifteen physiotherapeutic treatment sessions was based on the non-acceptance of the achieved result by the patient and the persistence of clinical findings at examination.
Statistical Analysis It was determined that to detect a 12-point difference with the Constant score with a power of 0.8, a significance level of 0.05, and an anticipated standard deviation of 20 points, forty-five patients were needed in each treatment arm. To compensate for expected losses to follow-up, 103 patients were included in the study. Raw data as shown in Table I were compared between groups. Analysis was performed by intention to treat, that is, all patients were analyzed in the group to which they were originally allocated. A linear mixed model for repeated measurements was used for analysis. The time of follow-up (as a categorical variable) and the choice of treatment were included in the model as explanatory factors, and a random intercept was incorporated. All main group analyses were performed adjusted for baseline differences of the respective dependent variable and age. For variables showing a significant interaction term between time and treatment (indicating a significant difference of time profiles between groups during follow-up, i.e., effect modification), between-group mean differences were estimated separately for each time of follow-up using regression analysis. For variables with a non-
significant interaction term between time and treatment, together with a significant finding for the main effect of treatment (indicating a constant between-group difference during follow-up), the model was recalculated with no interaction term included. No adjustment for multiple comparisons was considered to be necessary. Analyses of subgroups, based on the anatomic outcome (tear size increase, re-tears) and on the treatment that was given (post hoc as treated), was performed by mixed model analysis with no adjustment for baseline differences. Investigation of differences in patient satisfaction between groups was performed with an independent samples t test.
Source of Funding In support of the research for this manuscript, outside funding was given by the South-Eastern Norway Regional Health Authority. Funds were used to pay for salaries. The source of funding did not play a role in the investigation.
Results ne hundred and three patients met our criteria for inclusion and were randomly assigned to surgical treatment (n = 52) or physiotherapy (n = 51) (Fig. 1)34. The five-year follow-up rate was 98%. Demographic data (Table II) and study scores at enrollment (Table I) were comparable between the two treatment
O
1507 TH E JO U R NA L O F B O N E & JO I N T SU RG E RY J B J S . O RG V O L U M E 96-A N U M B E R 18 S E P T E M B E R 17, 2 014 d
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d
T E N D O N R E PA I R C O M PA R E D W I T H P H Y S I O T H E R A P Y I N T H E T R E AT M E N T O F R O TAT O R C U F F T E A R S
TABLE I Results of Primary and Secondary Outcome Measures
Outcome Measures
Primary Tendon Repair*†
Physiotherapy with Optional Secondary Repair*†
Between-Group Difference‡§
Main Effect#
Treatment · Time Interaction**
0.05
0.20
