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Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears

NCT01788683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-12-21

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tear

Interventions

PROCEDURE

Regenexx SD

stem cell treatment

OTHER

Exercise Therapy

exercise therapy control

Sponsors & Collaborators

  • Regenexx, LLC

    lead INDUSTRY

Principal Investigators

  • Christopher Centeno, MD · Centeno-Schultz Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2020-08-28
Completion
2022-07-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01788683 on ClinicalTrials.gov