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Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears

Primary Purpose

Rotator Cuff Tear

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Regenexx SD

Exercise Therapy

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Rotator Cuff, Rotator Cuff Tear, Supraspinatus Tear

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centeno-Schultz Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Regenexx SD

Exercise Therapy

Arm Description

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

Subjects will be instructed in a set of appropriate rotator cuff strengthening exercises and given an instructional hand-out to take home.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Pain Scales

Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint

MRI evidence of tendon repair

Comparison between groups of MRI evidence of tendon repair at 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.

Incidence of Complications and Adverse Events

Incidence and time to resolution of post-operative complications and adverse events between treatment groups.

Incidence of re-injection and surgical revision

Incidence of and time to re-injection and surgical revision between treatment groups.

Full Information

NCT ID

NCT01788683

First Posted

February 6, 2013

Last Updated

December 20, 2022

Sponsor

Regenexx, LLC

1. Study Identification

Unique Protocol Identification Number

NCT01788683

Brief Title

Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

February 2013 (Actual)

Primary Completion Date

August 28, 2020 (Actual)

Study Completion Date

July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regenexx, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tear

Keywords

Rotator Cuff, Rotator Cuff Tear, Supraspinatus Tear

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Regenexx SD

Arm Type

Active Comparator

Arm Description

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

Arm Title

Exercise Therapy

Arm Type

Active Comparator

Arm Description

Subjects will be instructed in a set of appropriate rotator cuff strengthening exercises and given an instructional hand-out to take home.

Intervention Type

Procedure

Intervention Name(s)

Regenexx SD

Intervention Description

stem cell treatment

Intervention Type

Other

Intervention Name(s)

Exercise Therapy

Intervention Description

exercise therapy control

Primary Outcome Measure Information:

Title

DASH Score Change from Baseline

Description

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.

Time Frame

Change from Baseline to 3 months

Secondary Outcome Measure Information:

Title

Mean Pain Scales

Description

Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint

Time Frame

3, 6, 12 and 24 months

Title

MRI evidence of tendon repair

Description

Comparison between groups of MRI evidence of tendon repair at 12 months

Time Frame

12 months

Title

Mean DASH scores

Description

Difference between treatment groups in mean Disabilities of Arm Shoulder and Hand (DASH) scores at 6, 12 and 24 months.

Time Frame

6, 12 and 24 months

Title

Incidence of Complications and Adverse Events

Description

Incidence and time to resolution of post-operative complications and adverse events between treatment groups.

Time Frame

24 months

Title

Incidence of re-injection and surgical revision

Description

Incidence of and time to re-injection and surgical revision between treatment groups.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Centeno, MD

Organizational Affiliation

Centeno-Schultz Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centeno-Schultz Clinic

City

Broomfield

State/Province

Colorado

ZIP/Postal Code

80021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32399045

Citation

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.

Results Reference

derived

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Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears

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