Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01788683
Study type	Interventional
Source	Regenexx, LLC
Contact
Status	Completed
Phase	N/A
Start date	February 2013
Completion date	July 28, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03663036` - Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis	N/A
Withdrawn	`NCT03319784` - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients	Phase 4
Suspended	`NCT03290196` - The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics	Phase 4
Active, not recruiting	`NCT03091075` - Oxandrolone Rotator Cuff Trial	N/A
Completed	`NCT03380533` - Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair	Phase 2/Phase 3
Completed	`NCT04566939` - A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine
Active, not recruiting	`NCT02716441` - Rotator Cuff Failure With Continuity
Completed	`NCT03540030` - Opioid-Free Shoulder Arthroplasty	Phase 4
Completed	`NCT02298023` - Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)	Phase 2
Completed	`NCT02850211` - A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair	Phase 4
Completed	`NCT01459536` - Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear	N/A
Completed	`NCT01383239` - Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs	N/A
Completed	`NCT01204606` - Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)	N/A
Completed	`NCT01170312` - Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation	N/A
Terminated	`NCT00936559` - Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair	Phase 1
Completed	`NCT00852657` - Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff	N/A
Active, not recruiting	`NCT00182299` - An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS	Phase 4
Recruiting	`NCT06120998` - Quality of Life After Arthroscopic Rotator Cuff Repair
Completed	`NCT05897866` - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM)	N/A
Completed	`NCT02644564` - Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries	N/A