Clinical trial NCT01850758: Regenexx™ SD Versus Exercise Therapy for ACL Tears
Official title: A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Partial and Complete, Non-retracted Anterior Cruciate Ligament Tears
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Tear
Keywords: ACL
Anterior Cruciate Ligament
ACL Tear
Anterior Cruciate Ligament Tear
Partial ACL Tear
Lead sponsor: Regenexx, LLC
Sponsor class: INDUSTRY
First posted: 2013-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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: 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 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 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,

Primary outcomes:
measure: IKDC Subjective Knee Evaluation Score Change from Baseline
timeFrame: Change from Baseline to 3 months
Secondary outcomes:
measure: Mean Pain Scales
timeFrame: 3, 6, 12 and 24 months
measure: Magnetic Resonance Evaluation of ligament repair
timeFrame: 6 months
measure: Mean IKDC Subjective Knee Evaluation Scores
timeFrame: 6, 12 and 24 months
measure: Incidence of complications and adverse events
timeFrame: 24 months
measure: Incidence of re-injection and surgical revision
timeFrame: 24 months
measure: Use of pain medications
timeFrame: 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Broomfield
country: United States
facility: Centeno-Schultz Clinic
state: Colorado
Study officials:
affiliation: Centeno-Schultz Clinic
name: Christopher Centeno, MD
role: PRINCIPAL_INVESTIGATOR
References: