Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions Pilot Trial

Phase 2

Terminated

Conditions: Articular Cartilage Injury

Interventions: Procedure: Microfracture
Device: Kensey Nash Corp. Cartilage Repair Device

Registration Number: NCT01183637

Lead Sponsor: Kensey Nash Corporation

Brief 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.

Detailed Description: Damage to articular cartilage in the knee by acute or chronic injury causes pain and limits knee function. If left untreated, damage to the articular cartilage can lead to painful osteoarthritis. The human body has a limited ability to regenerate or adequately repair damage to articular cartilage. There are several surgical techniques available to assist the repair of articular cartilage and improve pain and function. Microfracture is the most commonly used technique for cartilage repair. Microfracture involves the creation of numerous small fractures in the bone with a pick. These small fractures cause the release of multipotential stem cells from the bone marrow creating a clot on the surface. Over time, this clot causes reparative fibrocartilage to form. However, fibrocartilage is less durable and lacks the mechanical properties of normal articular cartilage. The majority of patients treated with microfracture has good results within the first 2 years after microfracture. However, beyond 2 years, functional deterioration is seen in over 50% of patients. Therefore, there is a clinical need for a product that improves surgical outcomes in patients with cartilage damage.

The Kensey Nash Corp. Cartilage Repair Device is a two layer, bioresorbable implant. The top layer consists of collagen fibers like those found in normal cartilage. The collagen layer is about as thick as the cartilage in human knees. The bottom layer of the Cartilage Repair Device mainly consists of a calcium mineral naturally found in human bones. The mineral is held within a biodegradable polymer material. The device has a highly porous structure that allows the blood, stem cells and joint fluid to infiltrate the device during the healing process. Over time, the top layer is designed to be replaced by cartilage and the bottom layer is designed to be replaced by bone.

Both microfracture and the Cartilage Repair Device are expected to reduce knee pain and increase knee function in a majority of patients during the first 2 years post-operative. However, if the Cartilage Repair Device produces better and more durable cartilage than the microfracture technique, those patients treated with the Cartilage Repair Device may have a better long term outcome.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 2

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Microfracture	Patients assigned to the Control Arm will receive treatment with the standard surgical technique known as microfracture.
Treatment	Kensey Nash Corp. Cartilage Repair Device	Patients assigned to the treatment arm will receive treatment with the Kensey Nash Corp. Cartilage Repair Device.

Primary Outcome Measures

Name	Time	Method
Patient Success	24 months	Improvement in pain, function, and cartilage defect appearance without any treatment related serious adverse events.

Secondary Outcome Measures

Name	Time	Method
Cartilage defect appearance on MRI	24 months	Cartilage defect filling, repair cartilage integration with surrounding native cartilage and presence of bony overgrowth will be assessed.
Knee Injury and Osteoarthritic Outcome Score ("KOOS")	24 months	Clinically significant improvement in the KOOS Pain, Activities of Daily Living, Symptoms, Sports \& Recreation and Quality of Life subscale scores
Lyshom Score	24 months	Clinical significant improvement in the Lysolm Knee Scale score

Trial Locations

Locations (2): Peninsula Orthopedic Associates
🇺🇸
Salisbury, Maryland, United States
U.S. Center for Sports Medicine
🇺🇸
Kirkwood, Missouri, United States