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:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
NCT ID:
NCT00613535
Eligibility Criteria:
Inclusion Criteria:Screening
* Age between 18 and 60 years
* BMI \<35
* Meniscal tear (medial or lateral) diagnosed by H+P exam and/or imaging in the index knee
* No severe joint space narrowing (IKDC Classification) seen on weight-bearing AP X-ray in the index knee
* No avascular necrosis in the index knee as evidenced by preop MRI obtained within 6 months prior to randomization
* No Varus (\>10 degrees) or Valgus (\>15 degrees)knee deformities as seen by AP X-ray in the index knee
* Minimal or no abnormality of contralateral knee as shown by clinical exam and/or imaging
* Candidate for unilateral arthroscopic treatment of the knee
* Visual Analog Scale (VAS) pain score of 30 mm or greater in the index knee at the time of screening
* Must be able to undergo MRI at required time points per appendix D
* Physically and mentally willing and able to comply with study requirements
* Must be willing and able to follow the standardized rehabilitation protocol (Appendix C)
* Subject must sign IRB approved informed consent form
Arthroscopy Inclusion Criteria:
* Arthroscopic confirmation of ICRS Grade II or III chondral lesion on the medial or lateral femoral condyle
Exclusion Criteria: Screening
* Knee instability, malalignment, or patellar tracking dysfunction in the index knee
* Inflammatory rheumatoid arthritis or other systemic inflammatory arthritis in the index knee or contralateral knee
* Previous total meniscectomy in the index knee
* Previous surgical treatment of the index knee by arthroscopy less than 2 years prior to treatment by this study
* Previous total meniscectomy
* Previous knee tendon and/or ligament repair or patellar surgery of index knee
* Previous microfracture or bone marrow stimulation of the index knee
* Previous unsuccessful osteotomy in the index knee
* Presence of fractures, osteocysts or osteolysis in the index knee
* Presence of osteoarthritis in the index knee
* Pre-existent osteoarthritis of weight-bearing joints (e.g. hips or contralateral knee) that adversely affects gait
* Participation in another clinical study
* Terminally ill
* Drug therapy for the index knee with systemic steroid therapy, steroid intra-articular therapy or intra-articular hyaluronic acid therapy within 2 months of enrollment into this study
* Receiving narcotic pain medication by prescription for other conditions unrelated to knee injury
* Contralateral knee involvement causing abnormal ambulation and non-compliance with rehabilitation
* Pregnant or suspected pregnant
* Coagulation disorder or patient is receiving anti-coagulants, which cannot be safely stopped for 14 days (7 days prior to surgery and 7 days post-surgery)
Arthroscopy Exclusion Criteria:
* Presence of Grade IV chondromalacia anywhere in the index knee
* ACL, PCL or MCL tear of the index knee
* Osteochondritis dissecans (OCD)of the index knee
* Meniscal tear requiring total meniscectomy
* Evidence of osteoarthritis in the index knee
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00613535
Study Brief:
Protocol Section:
NCT00613535