Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears

A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Non-retracted Supraspinatus Tendon Tears

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Procedure: Regenexx SD; Other: Exercise Therapy

Detailed 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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Broomfield, Colorado, United States, 80021
      • Centeno-Schultz Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Physical examination consistent with Rotator Cuff tear
• Unremitting pain in the affected shoulder for at least 3 months
• Significant functional disability related to pain, lack of strength, or other shoulder symptoms
• Positive diagnostic imaging, which may include arthrogram, ultrasound and/or MR, on the affected shoulder indicating a non-retracted supraspinatus tendon tear comprising at least one half the tendon thickness in the anterior-posterior and/or superior-inferior planes
• Reasonable movement of the non-treated arm, defined as a shoulder elevation of equal or more than 90°, and able to perform (post-injection) exercises
• Is independent, ambulatory, and can comply with all post-operative evaluations and visits

Exclusion Criteria:

• A massive rotator cuff tear as demonstrated by Grade 3 or less muscle strength on testing internal and external rotation of the affected shoulder
• Previous surgery to the affected shoulder
• Concomitant tears of biceps tendons
• Grade 2 or greater SLAP tear
• Type 3 acromion
• Significant bone spur in subacromial space
• Inflammatory or auto-immune based joint diseases or other upper extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
• Quinolone or Statin induced myopathy/ tendinopathy
• Kellgren-Lawrence grade 2 or greater glenohumeral osteoarthritis
• Adhesive capsulitis (mild or severe)
• Symptomatic cervical spine pathology (e.g. radicular cervical pain)
• Severe neurogenic inflammation of the cutaneous nerves about the shoulder
• Shoulder instability requiring surgical stabilization
• Contraindications for MRI
• Tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site
• Condition represents a worker's compensation case
• Currently involved in a health-related litigation procedure
• Is pregnant
• Bleeding disorders
• Currently taking anticoagulant or immunosuppressive medication
• Use of chronic opioid

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regenexx SD; Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged tendon.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Pain Scales	Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint	3, 6, 12 and 24 months
MRI evidence of tendon repair	Comparison between groups of MRI evidence of tendon repair at 12 months	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.	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.	24 months
Incidence of re-injection and surgical revision	Incidence of and time to re-injection and surgical revision between treatment groups.	24 months

Collaborators and Investigators

• Sponsor: Regenexx, LLC
• Investigators: Principal Investigator: Christopher Centeno, MD, Centeno-Schultz Clinic

Publications and helpful links

General Publications

• Centeno C, Fausel Z, Stemper I, Azuike U, Dodson E. A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis. Stem Cells Int. 2020 Jan 30;2020:5962354. doi: 10.1155/2020/5962354. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): August 28, 2020
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 7, 2013
• First Posted (Estimate): February 11, 2013

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Rotator Cuff; Rotator Cuff Tear; Supraspinatus Tear
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: RSI2012-RCT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No