Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears
The primary objective of this study is to compare the improvement in subject-reported clinical outcomes, for Regenexx SD treatment vs. Exercise Therapy of non-retracted supraspinatus tendon tears, from baseline to 3 months, with continued evaluation of efficacy and durability up to 24 months.
Secondary objectives include evaluation of US evidence of tendon repair; incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Non-retracted Supraspinatus Tendon Tears|
- DASH Score Change from Baseline [ Time Frame: Change from Baseline to 3 months ] [ Designated as safety issue: No ]The primary endpoint for this study is the difference between treatment groups in the within patient mean change from baseline to 3 months in Disabilities of the Arm Shoulder and Hand (DASH) scores.
- Mean Pain Scales [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint
- US evidence of tendon repair [ Time Frame: 3 months ] [ Designated as safety issue: No ]Comparison between groups of ultrasound evidence of tendon repair at 3 months
- Mean DASH scores [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]Difference between treatment groups in mean Disabilities of Arm Shoulder and Hand (DASH) scores at 6, 12 and 24 months.
- Incidence of Complications and Adverse Events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Incidence and time to resolution of post-operative complications and adverse events between treatment groups.
- Incidence of re-injection and surgical revision [ Time Frame: 24 months ] [ Designated as safety issue: No ]Incidence of and time to re-injection and surgical revision between treatment groups.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Regenexx SD
Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged tendon.
|Procedure: Regenexx SD|
Active Comparator: Exercise Therapy
Subjects will be instructed in a set of appropriate rotator cuff strengthening exercises and given an instructional hand-out to take home.
|Other: Exercise Therapy|
Prospective, randomized, controlled to include 25 subjects treated with Regenexx SD and 25 subjects treated with Exercise Therapy alone.
Subjects will have a non-retracted supraspinatus tendon tear comprising at least one half the tendon thickness in the anterior-posterior and/or superior-inferior planes as evidenced with positive diagnostic imaging such as arthrogram, ultrasound and/or MR.
Subjects will be enrolled within 60 days prior to Regenexx-SD injection or initiation of exercise therapy and take part in follow-up visits for two years following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post injection. Target enrollment is 50 subjects, to include 25 subjects treated with Regenexx SD and 25 subjects treated with exercise therapy alone.
The primary endpoint analysis will be conducted once all subjects reach the 3 month endpoint. At that point, subjects enrolled in the Exercise Therapy group will be given the option of crossing over to the Regenexx SD treatment groups. Subjects will continue to be followed through the 2 year endpoint with data analysis performed at the 1 year and 2 year time points.
Subjects will complete the study following the 2 year follow-up visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01788683
|Contact: Regenexx Informationfirstname.lastname@example.org|
|United States, Colorado|
|Broomfield, Colorado, United States, 80021|
|Principal Investigator: Christopher Centeno, MD|
|Sub-Investigator: Ron Hanson, MD|
|Principal Investigator:||Christopher Centeno, MD||Centeno-Schultz Clinic|