Regenexx™ SD Versus Exercise Therapy for ACL Tears

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Partial and Complete, Non-retracted Anterior Cruciate Ligament Tears

Conditions
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Anterior Cruciate Ligament Tear

Intervention / Treatment
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* Procedure: Regenexx SD
* Other: Exercise Therapy


Participation Criteria
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Eligibility Criteria
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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 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,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regenexx SD<br>Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged ligament. | Procedure: Regenexx SD<br>* stem cell treatment<br>|
| Active Comparator: Exercise Therapy<br>Subjects will be instructed in a set of appropriate knee strengthening exercises and given an instructional hand-out to take home. | Other: Exercise Therapy<br>* exercise therapy control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKDC Subjective Knee Evaluation 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 IKDC scores. | Change from Baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Pain Scales | Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint | 3, 6, 12 and 24 months | 
| Magnetic Resonance Evaluation of ligament repair | Comparison of Magnetic Resonance Evaluation of ligament repair at 6 months | 6 months | 
| Mean IKDC Subjective Knee Evaluation Scores | Difference between treatment groups in mean KDC Subjective Knee Evaluation Scores at 6, 12 and 24 months. | 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. | 24 months | 
| Incidence of re-injection and surgical revision | Incidence of and time to re-injection and surgical revision between treatment groups. | 24 months | 
| Use of pain medications | Difference between treatment groups in use of pain medications at each follow-up timepoint | 3, 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, Anterior Cruciate Ligament, ACL Tear, Anterior Cruciate Ligament Tear, Partial ACL Tear