Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01788683
• Other study ID #: RSI2012-RCT01
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: July 28, 2022

Study information

• Verified date: December 2022
• Source: Regenexx, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 28, 2022
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Procedure:
• Regenexx SD
stem cell treatment

Other:
• Exercise Therapy
exercise therapy control

Locations

Country	Name	City	State
United States	Centeno-Schultz Clinic	Broomfield	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Regenexx, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Pain Scales	Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint	3, 6, 12 and 24 months
Secondary	MRI evidence of tendon repair	Comparison between groups of MRI evidence of tendon repair at 12 months	12 months
Secondary	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
Secondary	Incidence of Complications and Adverse Events	Incidence and time to resolution of post-operative complications and adverse events between treatment groups.	24 months
Secondary	Incidence of re-injection and surgical revision	Incidence of and time to re-injection and surgical revision between treatment groups.	24 months