Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee. (CRB)
Primary Purpose
Knee Injury
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CR Plug
Sponsored by
About this trial
This is an interventional treatment trial for Knee Injury focused on measuring Cartilage injury, OATS, Knee injury, allograft, autograft
Eligibility Criteria
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
Sites / Locations
- American Sports Medicine Institute
- The Orthopedic Clinic Assoc
- Colorado Orthopedic Consultants
- Ohio State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CR Plug BackFill
Arm Description
Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00821873
Brief Title
Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee.
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RTI Surgical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injury
Keywords
Cartilage injury, OATS, Knee injury, allograft, autograft
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CR Plug BackFill
Arm Type
Experimental
Arm Description
Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
Intervention Type
Other
Intervention Name(s)
CR Plug
Intervention Description
CR Plug will be placed in the harvest site
Primary Outcome Measure Information:
Title
MRI to Evaluate Success of Outcome.
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Carter, MD
Organizational Affiliation
The Orthopedic Clinic, Assoc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Flanigan, MD
Organizational Affiliation
The Ohio State Univesity
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Phillip Stull, MD
Organizational Affiliation
Colorado Orthopedic Consultants
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Dugas, MD
Organizational Affiliation
American Sports Medicine Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
American Sports Medicine Institute
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
The Orthopedic Clinic Assoc
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Colorado Orthopedic Consultants
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee.
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