Regenexx™ SD Versus Exercise Therapy for ACL Tears

This study is currently recruiting participants.
Verified January 2014 by Regenerative Sciences, LLC
Sponsor:
Information provided by (Responsible Party):
Regenerative Sciences, LLC
ClinicalTrials.gov Identifier:
NCT01850758
First received: May 7, 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 vs. Exercise Therapy treatment of partial and complete, non-retracted knee ACL ligament tears, from baseline to 3 months, with continued evaluation of efficacy and durability up to 24 months.

Secondary objectives include evaluation of MRI 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
Anterior Cruciate Ligament 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 Partial and Complete, Non-retracted Anterior Cruciate Ligament Tears

Resource links provided by NLM:


Further study details as provided by Regenerative Sciences, LLC:

Primary Outcome Measures:
  • IKDC Subjective Knee Evaluation 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 IKDC 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

  • Magnetic Resonance Evaluation of ligament repair [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Comparison between groups of Magnetic Resonance Evaluation of ligament repair at 3 months

  • Mean IKDC Subjective Knee Evaluation Scores [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Difference between treatment groups in mean KDC Subjective Knee Evaluation 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.

  • Use of pain medications [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Difference between treatment groups in use of pain medications at each follow-up timepoint


Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: August 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 ligament.
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 with the exercise group crossing over to the injection group at 3 months.

Subjects will have a partial or complete, non-retracted ACL ligament tear as evidenced with MRI.

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. Subjects will continue to be followed through the 2 year endpoint with data analysis performed at the 1 year and 2 year time points.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pain, swelling, or functional disability in the affected knee with activity, having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 3 months or unable to return to normal day to day activities by 6 weeks
  • Physical examination consistent with lax ACL ligament (Anterior Drawer Test)
  • Abnormal Telos Arthrometer measurement
  • Positive diagnostic MR imaging of the affected knee with at least 1/3 of the ACL ligament at any area along its length having high signal on MRI PDFS/Fat Sat images.
  • Full range of motion of the affected knee (other than restriction clearly due to effusion)
  • Normal range of motion of the non-treated knee
  • Is independent, ambulatory, and can comply with all post-operative evaluations and visits

Exclusion Criteria:

  • A massive ACL tear or one that includes more than 2/3'rds of the ligament that's retracted.
  • Previous surgery to the affected ACL (i.e. previous ACL replacement with an autograft or allograft)
  • Prior ACL prolotherapy, PRP, corticosteroid injection or other injection therapy within the past three months,
  • Concomitant meniscus tear or cartilage injury that occurred at the same time as the as the ACL tear and which is considered a pain generator by the treating physician at the time intake into the study (i.e. a meniscus tear or cartilage lesion associated with an active BML).
  • Concomitant PCL, MCL, or LCL tears
  • Inflammatory or auto-immune based joint diseases or other lower 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 knee osteoarthritis
  • Significant knee extension lag compared to the opposite knee
  • Symptomatic lumbar spine pathology (e.g. radicular pain)
  • Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
  • 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
  • Allergy or intolerance to study medication
  • Use of chronic opioid,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01850758

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         
Sub-Investigator: John Schultz, MD         
Sub-Investigator: Ben Newton, 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: NCT01850758     History of Changes
Other Study ID Numbers: RSI2013-RCT01
Study First Received: May 7, 2013
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Regenerative Sciences, LLC:
ACL
Anterior Cruciate Ligament
ACL Tear
Anterior Cruciate Ligament Tear
Partial ACL Tear

Additional relevant MeSH terms:
Lacerations
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on April 14, 2014