Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT01850758
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,
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01850758
Study Brief:
Protocol Section:
NCT01850758