Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Rotator Cuff Tear
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
Description
Rotator cuff repair carried out with current techniques has shown favourable results in terms of pain relief. However the re-tear rates remain high and are associated with significant morbidity in terms of functional outcome and shoulder strength. As rotator cuff disease becomes ever more prevalent ...
Rotator cuff repair carried out with current techniques has shown favourable results in terms of pain relief. However the re-tear rates remain high and are associated with significant morbidity in terms of functional outcome and shoulder strength. As rotator cuff disease becomes ever more prevalent with our aging population, it is imperative to determine if healing rates can be improved with autologous stem cell enhancement with pre-surgical preparation of the tendon insertion site through trephination. This trial is necessary both to provide optimal care of our patients, and to do so in a fiscally responsible fashion. The primary outcome measure the re-tear rate as measured by ultrasound at 24 months post-operatively. The secondary outcome measures are Western Ontario Rotator Cuff Index (WORC), Constant Score, and the American Shoulder and Elbow surgeons standardized assessment of shoulder function (ASES).
Tracking Information
- NCT #
- NCT01877772
- Collaborators
- Panam Clinic
- London Health Sciences Centre
- University of Alberta
- Investigators
- Principal Investigator: Peter Lapner, MD OHRI