An interventional study of Regenexx SD and Exercise Therapy in Rotator Cuff Tear, sponsored by Regenexx, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-12-21.
Sponsored by Regenexx, LLC · Not applicable, Interventional, and Treatment
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.
Prospective, randomized, controlled to include 34 subjects treated with Regenexx SD and 17 subjects treated with Exercise Therapy alone (2:1 randomization).
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.
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.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's enrollment of 51 is below the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Regenexx, LLC is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged tendon.
Procedure: Regenexx SD
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
stem cell treatment
exercise therapy control
DASH Score Change from Baseline
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.
Time frame: Change from Baseline to 3 months
Mean Pain Scales
Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint
Time frame: 3, 6, 12 and 24 months
MRI evidence of tendon repair
Comparison between groups of MRI evidence of tendon repair at 12 months
Time frame: 12 months
Mean DASH scores
Difference between treatment groups in mean Disabilities of Arm Shoulder and Hand (DASH) scores at 6, 12 and 24 months.
Time frame: 6, 12 and 24 months
Incidence of Complications and Adverse Events
Incidence and time to resolution of post-operative complications and adverse events between treatment groups.
Time frame: 24 months
Incidence of re-injection and surgical revision
Incidence of and time to re-injection and surgical revision between treatment groups.
Time frame: 24 months
Plan to share: No
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Regenexx, LLC