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The hypothesis is that microfractures in the footprint of the humerus will aid to improve the tendon healing to the bone. The aim of the study is to investigate whether the use of microfractures at the footprint of the rotator cuff will improve the tendon healing when reinserted. Patients undergoing surgery for a rotator cuff injury will be randomised to repair with or without microfracture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microfracture | Experimental | Rotator Cuff Repair AND Microfracture at rotatorcuff footprint |
|
| NO microfracture | Active Comparator | Rotator cuff reinsertion without microfracture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microfracture | Procedure | Rotator Cuff Repair AND Microfracture |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Western Ontario Rotator Cuff Index (WORC) | Standardized questionnaire | 0, 3 and 12 months |
| Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) | Standardized questionnaire | 0, 3 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| MRI integrity of the rotatorcuff |
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Strength of rotatorcuff | Strength 0-5 in abduction and external rotation. | 3 and 12 months |
| Function of rotatorcuff | Range of movement in abduction and external rotation in full degrees. |
Inclusion Criteria:
- Patients over the age of 18 with a full thickness rotatorcuff rupture.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Blønd, M.D | Køge Sygehus | Study Director |
| Gunner S Barfoed, M.D | Køge Sygehus | Study Director |
| Thomas JN Sørensen, M.D | Køge Sygehus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Køge Sygehus | Køge | Lykkebækvej 1 | 4600 | Denmark |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D054544 | Arthroplasty, Subchondral |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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| NO microfracture |
| Procedure |
Rotator Cuff Repair without microfracture |
|
| 3 and 12 months |
| Complications | Assesses the complication rate in each group such as infection, bleeding and reoperation. | 12 months |