Microfracture in Rotator Cuff Injury Repair
Not Applicable
Suspended
- Conditions
- Rupture of the Rotator Cuff
- Interventions
- Procedure: NO microfractureProcedure: Microfracture
- Registration Number
- NCT02097901
- Lead Sponsor
- Zealand University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Patients over the age of 18 with a full thickness rotatorcuff rupture.
Exclusion Criteria
- Isolated rupture of the subscapularis
- Tendon atrophia
- Goutallier grade 3-4 fatty degeneration
- Fracture surgery in same shoulder
- Inflammatory or neurologic affection of shoulder
- Other disabling disease
- Unwilling to participate in study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NO microfracture NO microfracture Rotator cuff reinsertion without microfracture Microfracture Microfracture Rotator Cuff Repair AND Microfracture at rotatorcuff footprint
- Primary Outcome Measures
Name Time Method Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) 0, 3 and 12 months Standardized questionnaire
Change in Western Ontario Rotator Cuff Index (WORC) 0, 3 and 12 months Standardized questionnaire
- Secondary Outcome Measures
Name Time Method MRI integrity of the rotatorcuff 12 months * Intact rotatorcuff
* Partial rupture
* Full thickness rupture
Trial Locations
- Locations (1)
Køge Sygehus
🇩🇰Køge, Lykkebækvej 1, Denmark