Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Regenerative Sciences, LLC
Sponsor:
Information provided by (Responsible Party):
Regenerative Sciences, LLC
ClinicalTrials.gov Identifier:
NCT01788683
First received: February 6, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Rotator Cuff Tear
Procedure: Regenexx SD
Other: Exercise Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Non-retracted Supraspinatus Tendon Tears

Resource links provided by NLM:


Further study details as provided by Regenerative Sciences, LLC:

Primary Outcome Measures:
  • DASH Score Change from Baseline [ Time Frame: Change from Baseline to 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint

  • US evidence of tendon repair [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Comparison between groups of ultrasound evidence of tendon repair at 3 months

  • Mean DASH scores [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Incidence and time to resolution of post-operative complications and adverse events between treatment groups.

  • Incidence of re-injection and surgical revision [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Incidence of and time to re-injection and surgical revision between treatment groups.


Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Regenexx SD
Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged tendon.
Procedure: Regenexx SD
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

Detailed Description:

Prospective, randomized, controlled to include 25 subjects treated with Regenexx SD and 25 subjects treated with Exercise Therapy alone.

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. Target enrollment is 50 subjects, to include 25 subjects treated with Regenexx SD and 25 subjects treated with exercise therapy alone.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 multiple rotator cuff or 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01788683

Contacts
Contact: Regenexx Information 1-888-525-3005 studycandidate@regenexx.com

Locations
United States, Colorado
Centeno-Schultz Clinic Recruiting
Broomfield, Colorado, United States, 80021
Principal Investigator: Christopher Centeno, MD         
Sub-Investigator: Ron Hanson, MD         
Sponsors and Collaborators
Regenerative Sciences, LLC
Investigators
Principal Investigator: Christopher Centeno, MD Centeno-Schultz Clinic
  More Information

No publications provided

Responsible Party: Regenerative Sciences, LLC
ClinicalTrials.gov Identifier: NCT01788683     History of Changes
Other Study ID Numbers: RSI2012-RCT01
Study First Received: February 6, 2013
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Regenerative Sciences, LLC:
Rotator Cuff
Rotator Cuff Tear
Supraspinatus Tear

ClinicalTrials.gov processed this record on October 29, 2014