Clinical trial NCT00793104: Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.
Official title: Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Focal Cartilage Lesions in the Femoral Condyle
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Knee Injury
Keywords: allograft
knee injury
cartilage injury
Osteochondral defects in the articular femoral cartilage
Lead sponsor: RTI Surgical
Sponsor class: INDUSTRY
First posted: 2008-11-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee

Detailed description: The specific aim in this study is to assess the ability of the CR-Plug to treat osteochondral focal defects of less than 2.5 cm squared at high-load-bearing femoral condyle.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Skeletally mature
* Have one symptomatic score International Cartilage Repair Score (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle (MFC) or Lateral Femoral Condyle (LFC). Symptoms must include pain, pain with weight bearing and squatting, locking of joints, and/or swelling
* Functional meniscal tissue (defined as 5 mm or more width)
* A score of = or greater than 4 on the VAS questionnaire

Exclusion Criteria:

* Associated tibial or patellar articular cartilage defect greater than 2 ICRS
* Osteoarthritis of either knee
* Mechanical axis malalignment of greater than 5 degrees
* Patellofemoral incongruity of Merchant view
* One or more multiple defects greater than 2.5 cm
* Osteochondritis dissecans (OCD) with depth of bone loss greater than 4 mm
* Ligament treatments in the affected knee within one yer prior to current study
* Previous surgical meniscus treatments in the affected knee in the last 6 months
* Less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment
* Use of any investigational therapy with in 30 days prior to the first visit
* Corticosteroid or viscosupplementation within the past 3 months
* A score of 3 or less on the VAS Questionnaire
* Active gout or pseudogout or systemic inflammatory condition

Primary outcomes:
measure: The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months
timeFrame: 24 months
Secondary outcomes:
measure: Current Health Assessment
timeFrame: 24 months, MRI only at 12 and 24 months
measure: Lysholm With Tegner Score
timeFrame: 24 months
measure: International Knee Documentation Committee (IKDC) at 24 Months.
timeFrame: 24 months
measure: MRI Evaluation Score
timeFrame: 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kerlan Jobe Orthopaedic Clinic
state: California
city: Denver
country: United States
facility: Colorado Orthopedic Consultants
state: Colorado
city: Indianapolis
country: United States
facility: OrthoIndy, Inc
state: Indiana
Study officials:
affiliation: OrthoIndy, Inc
name: Jack Farr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kerlan Jobe Orthopaedic Clinic
name: Ralph A Gambardella, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Colorado Orthopedic Consultants
name: Stewart Weinerman, MD
role: PRINCIPAL_INVESTIGATOR
References: