TerminatedPhase 2

Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions Pilot Trial

Stopped: Study enrollment rate was far slower than anticipated. Study was stopped for business purposes.

United States2 participantsStarted 2010-06

Plain-language summary

The Kensey Nash Corp. Cartilage Repair Device is a bioresorbable scaffold designed to promote repair of knee cartilage and subchondral bone. Subjects with knee cartilage damage meeting eligibility criteria will be randomly assigned to receive treatment with the Cartilage Repair Device or a standard surgical technique called microfracture. The purpose of the study is to evaluate the initial safety and effectiveness of the Cartilage Repair Device compared to microfracture.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 21 years old and skeletally mature * KOOS Pain subscale score is less than 65 (i.e. moderate pain) * KOOS Activities of Daily Living score is less than 70 (i.e. moderate functional limitations) * ICRS grade 3 or 4 cartilage lesion on the medial femoral condyle, lateral femoral condyle or trochlea measuring less than or equal to 15mm in diameter * Stable meniscus with greater than 50% remaining bilaterally * Mental capacity and willingness to comply with the post-operative rehabilitation plan and follow-up evaluations * Written informed consent Exclusion Criteria: * Body mass index greater than 35 * Contraindication for MRI * Previous microfracture, autograft implantation, allograft implantation or autologous chondrocyte implantation procedure on the damaged cartilage surface * Knee ligament surgery within the past 6 months * Clinically significant knee malalignment * Osteoarthritis in the knee * Multiple cartilage lesions * Inflammatory arthropathy (i.e. rheumatoid arthritis, systemic lupus or active gout) * Active infection in either lower limb * Hyaluronic acid or cortisone injections within the past 3 months * History of substance abuse * Current participation in a study of an investigational product for a similar purpose * Active litigation for the knee injury

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient Success

Timeframe: 24 months

Trial details

NCT IDNCT01183637

SponsorKensey Nash Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Articular Cartilage Injury trials