Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee. (CRB)

RTI Surgical

Status and phase

Completed

Phase 3

Conditions

Knee Injury

Treatments

Other: CR Plug

Study type

Interventional

Funder types

Industry

Identifiers

NCT00821873

WIRB #20080290 (Other Identifier)

CRB2008

Details and patient eligibility

About

The main objective of this study is to test the ability of an allograft plug to provide a successful repair of an osteochondral defect left at the harvest site during OATS procedure.

Full description

The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment at the site that your tissue was removed, thereby filling the hole created during the OATS procedure.At the present, OATS is used for knee articular cartilage defects or injuries smaller than the size of a dime (or 2.5 cm2) in the areas that bear weight have been commonly treated by using a tiny cylinder of the subjects' own tissue called an osteochondral autograft (OATS).

Enrollment

9 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Are male or female at least 18 years of age and up to 55 years of age
Must be skeletally mature
Have a grade III or IV lesion in femoral condyle

Exclusion criteria

Skeletally immature
Osteoarthritic knees, osteonecrotic knees, osteophyte formation
Use of any investigational therapy within thirty (30) days prior to the first visit