Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions Pilot Trial

NCT01183637 | Terminated Phase 2 DMC

• 1 other identifier: EAGLE Pilot
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Articular Cartilage Injury

Keywords

Cartilage; Knee; Osteochondral

Outcome Measures

Primary Outcomes (1)

• Patient Success

  Improvement in pain, function, and cartilage defect appearance without any treatment related serious adverse events.

  24 months

Secondary Outcomes (3)

• Knee Injury and Osteoarthritic Outcome Score ("KOOS")

  24 months

• Cartilage defect appearance on MRI

  24 months

• Lyshom Score

  24 months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Device: Kensey Nash Corp. Cartilage Repair Device

Control

ACTIVE COMPARATOR

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

Procedure: Microfracture

Interventions

Kensey Nash Corp. Cartilage Repair Device 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.

Treatment

Microfracture PROCEDURE

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.

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kensey Nash Corporation: lead

Study Sites (2)

Peninsula Orthopedic Associates

Salisbury, Maryland, 21804, United States

Location

U.S. Center for Sports Medicine

Kirkwood, Missouri, 63122, United States

Location

MeSH Terms

Interventions

Arthroplasty, Subchondral

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: August 17, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: May 25, 2015

Record last verified: 2015-05

Locations

US (2)