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The purpose of this study is to compare treatment benefits from surgical treatment by tendon repair and from physiotherapy for small and medium-sized rotator cuff tears.
Surgical treatment by tendon repair or physiotherapy are accepted treatment options for small and medium-sized rotator cuff tears, but have never been compared in randomised, controlled studies.
In this study, patients presenting clinical signs together with imaging findings (MRI and sonography) for a full-thickness rotator cuff tear will be randomly allocated to surgery (tendon repair) or physiotherapy. Outcome measuring will be performed by the Constant score, the self report section of the American Shoulder and Elbow Surgeons score (ASES), the Short Form 36 Health Survey (SF-36) and subscores for shoulder motion, pain, strength and patient satisfaction. Scores will be taken at baseline and after 6 months,1, 2, 5, 10 and 15 years by a blinded assessor. All operated shoulders will be controlled by MRI after one year. Patients with no effect from physiotherapy after at least 15 treatment sessions will be offered secondary surgical treatment, and scoring results from last follow-up before surgery will be carried forward to analysis, according to an intention to treat principle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical treatment | Active Comparator | Open or mini-open tendon repair with acromioplasty |
|
| Physiotherapy | Active Comparator | Physiotherapy by exercises |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tendon repair with acromioplasty | Procedure | Open or mini-open tendon repair in combination with an acromioplasty and eventually a tenodesis of the long head of the biceps |
|
| Measure | Description | Time Frame |
|---|---|---|
| Constant score | baseline, 6 months, 1, 2, 5, 10, 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| self report section of the American Shoulder and Elbow Surgeons score (ASES) | baseline, 6 months, 1, 2, 5, 10, 15 years | |
| Short Form 36 Health Survey (SF-36) | baseline, 6 months, 1, 2, 5, 10, 15 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Moosmayer, MD | Vestre Viken Hospital Trust | Principal Investigator |
| Hans-Joergen Smith, MD, PhD | University of Oslo, Rikshospitalet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martina Hansen's Hospital | Sandvika | 1306 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20044684 | Result | Moosmayer S, Lund G, Seljom U, Svege I, Hennig T, Tariq R, Smith HJ. 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. J Bone Joint Surg Br. 2010 Jan;92(1):83-91. doi: 10.1302/0301-620X.92B1.22609. | |
| 25232074 |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Physiotherapy | Procedure | According to a rehabilitation program which was established prior to study start. |
|
| Patient satisfaction | 1, 2, 5, 10, 15 years |
| Moosmayer S, Lund G, Seljom US, Haldorsen B, Svege IC, Hennig T, Pripp AH, Smith HJ. 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. J Bone Joint Surg Am. 2014 Sep 17;96(18):1504-14. doi: 10.2106/JBJS.M.01393. |
| 31220021 | Result | Moosmayer S, Lund G, Seljom US, Haldorsen B, Svege IC, Hennig T, Pripp AH, Smith HJ. At a 10-Year Follow-up, Tendon Repair Is Superior to Physiotherapy in the Treatment of Small and Medium-Sized Rotator Cuff Tears. J Bone Joint Surg Am. 2019 Jun 19;101(12):1050-1060. doi: 10.2106/JBJS.18.01373. |