Anterior Cruciate Ligament Tear Clinical Trial
Official title:
A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Partial and Complete, Non-retracted Anterior Cruciate Ligament Tears
NCT number | NCT01850758 |
Other study ID # | RSI2013-RCT01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | March 8, 2022 |
Verified date | July 2022 |
Source | Regenexx, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 8, 2022 |
Est. primary completion date | May 22, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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, |
Country | Name | City | State |
---|---|---|---|
United States | Centeno-Schultz Clinic | Broomfield | Colorado |
Lead Sponsor | Collaborator |
---|---|
Regenexx, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Mean Pain Scales | Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint | 3, 6, 12 and 24 months | |
Secondary | Magnetic Resonance Evaluation of ligament repair | Comparison of Magnetic Resonance Evaluation of ligament repair at 6 months | 6 months | |
Secondary | 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 | |
Secondary | Incidence of complications and adverse events | Incidence and time to resolution of post-operative complications and adverse events between treatment groups. | 24 months | |
Secondary | Incidence of re-injection and surgical revision | Incidence of and time to re-injection and surgical revision between treatment groups. | 24 months | |
Secondary | Use of pain medications | Difference between treatment groups in use of pain medications at each follow-up timepoint | 3, 6, 12 and 24 months |
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