Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears

NCT01788683 | Completed

• 1 other identifier: RSI2012-RCT01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rotator Cuff; Rotator Cuff Tear; Supraspinatus Tear

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mean Pain Scales

  3, 6, 12 and 24 months

• MRI evidence of tendon repair

  12 months

• Mean DASH scores

  6, 12 and 24 months

• Incidence of Complications and Adverse Events

  24 months

• Incidence of re-injection and surgical revision

  24 months

Study Arms (2)

Regenexx SD

ACTIVE COMPARATOR

Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged tendon.

Procedure: Regenexx SD

Exercise Therapy

ACTIVE COMPARATOR

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

Interventions

Regenexx SD PROCEDURE

stem cell treatment

Regenexx SD

Exercise Therapy OTHER

exercise therapy control

Exercise Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regenexx, LLC: lead

Study Sites (1)

Centeno-Schultz Clinic

Broomfield, Colorado, 80021, United States

Location

Related Publications (2)

• Centeno CJ, Fausel Z, Dodson E, Berger DR, Steinmetz NJ. Percutaneous bone marrow concentrate and platelet products versus exercise therapy for the treatment of rotator cuff tears: a randomized controlled, crossover trial with 2-year follow-up. BMC Musculoskelet Disord. 2024 May 18;25(1):392. doi: 10.1186/s12891-024-07519-6.

  PMID: 38762734 DERIVED

• 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.

  PMID: 32399045 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Christopher Centeno, MD

  Centeno-Schultz Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 11, 2013
• Study Start: February 1, 2013
• Primary Completion: August 28, 2020
• Study Completion: July 28, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)