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
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 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 ] [ 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 IKDC 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
- Magnetic Resonance Evaluation of ligament repair [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ 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.
- Use of pain medications [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]Difference between treatment groups in use of pain medications at each follow-up timepoint
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||August 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 ligament.
|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 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|