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

Knee Injury Clinical Trial

— CRB  

Official title:

Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR Plug) for Repair of Defects Created at the Harvest Site During the Osteochondral Autograft Transfer System(OATS)Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821873
• Other study ID #: CRB2008
• Secondary ID: WIRB #20080290
• Status: Completed
• Phase: Phase 3
• First received: January 12, 2009
• Last updated: November 6, 2013
• Start date: December 2008
• Est. completion date: July 2012

Study information

• Verified date: November 2013
• Source: RTI Surgical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Injuries
• Knee Injury

Intervention

Other:
• CR Plug
CR Plug will be placed in the harvest site

Locations

Country	Name	City	State
United States	American Sports Medicine Institute	Birmingham	Alabama
United States	Ohio State University	Columbus	Ohio
United States	Colorado Orthopedic Consultants	Englewood	Colorado
United States	The Orthopedic Clinic Assoc	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
RTI Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI to Evaluate Success of Outcome.	The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at 24 months post-operatively.; The MRI scans were evaluated by a radiologist for several categories and these were then scored and transformed to an index, resulting in an outcome score ranging from 0-100 In this scale, 0 is the worst possible and 100 is the best possible score.	24 months	No