Regenexx™ SD Versus Exercise Therapy for ACL Tears
The primary objective of this study is to compare the improvement in subject-reported clinical outcomes for Regenexx SD vs. Exercise Therapy treatment of partial and complete, non-retracted knee ACL ligament tears, from baseline to 3 months, with continued evaluation of efficacy and durability up to 24 months.
Secondary objectives include evaluation of MRI 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.
|Anterior Cruciate Ligament Tear||Procedure: Regenexx SD Other: Exercise Therapy|
|Study Design:||Allocation: Randomized
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 Partial and Complete, Non-retracted Anterior Cruciate Ligament Tears|
- IKDC Subjective Knee Evaluation Score Change from Baseline [ Time Frame: Change from Baseline to 3 months ]The primary endpoint for this study is the difference between treatment groups in the within patient mean change from baseline to 3 months in IKDC scores.
- Mean Pain Scales [ Time Frame: 3, 6, 12 and 24 months ]Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint
- Magnetic Resonance Evaluation of ligament repair [ Time Frame: 3 months ]Comparison between groups of Magnetic Resonance Evaluation of ligament repair at 3 months
- Mean IKDC Subjective Knee Evaluation Scores [ Time Frame: 6, 12 and 24 months ]Difference between treatment groups in mean KDC Subjective Knee Evaluation Scores at 6, 12 and 24 months.
- Incidence of complications and adverse events [ Time Frame: 24 months ]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 ]Incidence of and time to re-injection and surgical revision between treatment groups.
- Use of pain medications [ Time Frame: 3, 6, 12 and 24 months ]Difference between treatment groups in use of pain medications at each follow-up timepoint
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||December 2017 (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 ligament.
Procedure: Regenexx SD
stem cell treatment
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
exercise therapy control
Prospective, randomized, controlled to include 25 subjects treated with Regenexx SD and 25 subjects treated with exercise therapy alone with the exercise group crossing over to the injection group at 3 months.
Subjects will have a partial or complete, non-retracted ACL ligament tear as evidenced with MRI.
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.
The primary endpoint analysis will be conducted once all subjects reach the 3 month endpoint. Subjects will continue to be followed through the 2 year endpoint with data analysis performed at the 1 year and 2 year time points.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01850758
|Contact: Regenexx Informationfirstname.lastname@example.org|
|United States, Colorado|
|Broomfield, Colorado, United States, 80021|
|Principal Investigator: Christopher Centeno, MD|
|Sub-Investigator: Ron Hanson, MD|
|Sub-Investigator: John Schultz, MD|
|Sub-Investigator: Ben Newton, MD|
|Principal Investigator:||Christopher Centeno, MD||Centeno-Schultz Clinic|