Status:
COMPLETED
Regenexx™ SD Versus Exercise Therapy for ACL Tears
Lead Sponsor:
Regenexx, LLC
Conditions:
Anterior Cruciate Ligament Tear
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 l...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 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,
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01850758
Start Date
May 1 2013
End Date
March 8 2022
Last Update
July 8 2022
Active Locations (1)
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1
Centeno-Schultz Clinic
Broomfield, Colorado, United States, 80021