Recruitment

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