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 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
NCT ID:
NCT02309957
Eligibility Criteria:
Inclusion Criteria:
* Pre-procedure KOOS Pain subscale score less than or equal to 70.
* ICRS grade 3 or 4 focal articular cartilage lesion on the medial femoral condyle, lateral femoral condyle or trochlea, which measures less than or equal to15mm in diameter.
* Cartilage lesion is amenable to treatment with a single BioMatrix CRD or an osteochondral autograft.
Exclusion Criteria:
* Previous cartilage repair procedure (i.e., microfracture, OATS, ACI) at the intended implantation site.
* Clinically significant (\> 5 degrees) varus or valgus malalignment in either knee.
* Osteoarthritis in the injured knee.
* Inflammatory arthropathy
* Osteomyelitis or other active infection in either lower limb.
* Cortisone or hyaluronic acid knee injections in the past 3 months
* Body mass index greater than 35.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02309957
Study Brief:
Protocol Section:
NCT02309957