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The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair.
Rotator cuff tendon injury ranks among the most prevalent of shoulder disorders causing pain and impaired function, and is a major socioeconomic burden on society. The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair. Our primary goal is to compare clinical and structural results after rotator cuff repair and to compare a restrictive and an active postoperative rehabilitation protocol. Our secondary goal is to establish guidelines for optimized rehabilitation after rotator cuff repair to ensure the best possible outcome for this large group of patients. Our aim is also to establish guidelines for timing of return to work. The major complications following rotator cuff repair and the current rehabilitation regimens are rotator cuff retears and postoperative stiffness. The information obtained in this study may enable development of targeted, cost-effective treatment and rehabilitation with good, lasting long-term results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 weeks with simple sling | Active Comparator | Early motion after arthroscopic rotator cuff repair. |
|
| 6 weeks with neutral brace | Active Comparator | Delayed motion after arthroscopic rotator cuff repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simple sling. | Device |
| ||
| Neutral brace |
| Measure | Description | Time Frame |
|---|---|---|
| We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint | We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint. We will compare WORC of the early range of motion group to a delayed range of motion group. | One year |
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Inclusion Criteria: Repairable partial- or full-thickness rotator cuff tear affecting supraspinatus and/or upper infraspinatus tendon -
Exclusion Criteria: Irreparable or incomplete repairable tears of supraspinatus and/or infraspinatus tendon.
Large/massive rotator cuff tear. Diabetes mellitus. Systemic inflammatory disorder. Fatty muscle infiltration >grade 2 (Goutallier). Subscapularis tendon tear. Adhesive capsulitis. Concomitant labral repair. Revision repair.
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| Name | Affiliation | Role |
|---|---|---|
| Sigbjørn Dimmen, MD, Phd | Lovisenberg Diaconal Hospital, Oslo, Norway | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lovisenberg Diaconal Hospital | Oslo | 0446 | Norway |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 22, 2024 | |
| Reset | Aug 16, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 22, 2024 | Aug 16, 2024 |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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