Regenexx™ SD Versus Exercise Therapy for ACL Tears

Completed · Not applicable

Conditions studied: Anterior Cruciate Ligament Tear

In brief

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.

Key facts

Study ID

NCT01850758

Run by

Regenexx, LLC

People needed

50

Starts

2013-05-01

Expected to finish

2022-03-08

Last updated by the study team

2022-07-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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,

Where it is running

• Centeno-Schultz Clinic — Broomfield, Colorado, United States

Full record on ClinicalTrials.gov

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