Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions Pilot Trial - Full Text View

Sponsor:	Kensey Nash Corporation
Information provided by:	Kensey Nash Corporation
ClinicalTrials.gov Identifier:	NCT01183637

Purpose

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.

Condition	Intervention	Phase
Articular Cartilage Injury	Device: Kensey Nash Corp. Cartilage Repair Device Procedure: Microfracture	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Initial Safety and Effectiveness Study of the Kensey Nash Corp. Cartilage Repair Device for Knee Cartilage Lesion Repair

Further study details as provided by Kensey Nash Corporation:

Primary Outcome Measures:

Patient Success [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Improvement in pain, function, and cartilage defect appearance without any treatment related serious adverse events.

Secondary Outcome Measures:

Knee Injury and Osteoarthritic Outcome Score ("KOOS") [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Clinically significant improvement in the KOOS Pain, Activities of Daily Living, Symptoms, Sports & Recreation and Quality of Life subscale scores
Cartilage defect appearance on MRI [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Cartilage defect filling, repair cartilage integration with surrounding native cartilage and presence of bony overgrowth will be assessed.
Lyshom Score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Clinical significant improvement in the Lysolm Knee Scale score

Estimated Enrollment:	30
Study Start Date:	June 2010
Estimated Study Completion Date:	April 2016
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment Patients assigned to the treatment arm will receive treatment with the Kensey Nash Corp. Cartilage Repair Device.	Device: Kensey Nash Corp. Cartilage Repair Device To perform the Cartilage Repair Device implantation procedure, the surgeon first removes the damaged cartilage. Then, the surgeon creates a cylindrical hole in the bone below the area of damaged cartilage. The Cartilage Repair Device is then implanted into the hole so that the surface is level with the surrounding native cartilage. The Cartilage Repair Device will then absorb blood and bone marrow from the bone to begin the healing process.
Active Comparator: Control Patients assigned to the Control Arm will receive treatment with the standard surgical technique known as microfracture.	Procedure: Microfracture To perform the microfracture technique, the surgeon will first remove the damaged cartilage. Then, the surgeon will make a number of small fractures in the bone below the area of damaged cartilage. The fractures cause the bone to bleed and a clot to form over the exposed bone. Over time, the clot forms a layer of fibrocartilage over the bone.

Arms

Assigned Interventions

Experimental: Treatment

Patients assigned to the treatment arm will receive treatment with the Kensey Nash Corp. Cartilage Repair Device.

Device: Kensey Nash Corp. Cartilage Repair Device

To perform the Cartilage Repair Device implantation procedure, the surgeon first removes the damaged cartilage. Then, the surgeon creates a cylindrical hole in the bone below the area of damaged cartilage. The Cartilage Repair Device is then implanted into the hole so that the surface is level with the surrounding native cartilage. The Cartilage Repair Device will then absorb blood and bone marrow from the bone to begin the healing process.

Active Comparator: Control

Patients assigned to the Control Arm will receive treatment with the standard surgical technique known as microfracture.

Procedure: Microfracture

To perform the microfracture technique, the surgeon will first remove the damaged cartilage. Then, the surgeon will make a number of small fractures in the bone below the area of damaged cartilage. The fractures cause the bone to bleed and a clot to form over the exposed bone. Over time, the clot forms a layer of fibrocartilage over the bone.

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183637

Locations

United States, Maryland
Peninsula Orthopedic Associates
Salisbury, Maryland, United States, 21804
United States, Missouri
U.S. Center for Sports Medicine
Kirkwood, Missouri, United States, 63122

Sponsors and Collaborators

Kensey Nash Corporation

Investigators

Principal Investigator:	Richard C Lehman, M.D.	U.S. Center for Sports Medicine, Kirkwood, MO
Principal Investigator:	Phillip A Davidson, M.D.	Heiden - Davidson Orthopedics, Park City, UT

More Information

No publications provided

Responsible Party:	Forde Hansell, Director of Clinical Research
ClinicalTrials.gov Identifier:	NCT01183637 History of Changes
Other Study ID Numbers:	EAGLE Pilot
Study First Received:	July 28, 2010
Last Updated:	February 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Kensey Nash Corporation:

Cartilage
Knee
Osteochondral

ClinicalTrials.gov processed this record on May 23, 2012