Back to resultsEvaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.
Primary Purpose
Knee Injury
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placement of allograft CR Plug in primary injury site
Sponsored by
About this trial
This is an interventional treatment trial for Knee Injury focused on measuring allograft, knee injury, cartilage injury, Osteochondral defects in the articular femoral cartilage
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
Sites / Locations
- Kerlan Jobe Orthopaedic Clinic
- Colorado Orthopedic Consultants
- OrthoIndy, Inc
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CR Plug
Arm Description
Placement of allograft CR Plug in primary injury site
Outcomes
Primary Outcome Measures
The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months
The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Secondary Outcome Measures
Current Health Assessment
Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0-100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.
Lysholm With Tegner Score
The Tegner activity scale was designed as a score of activity level to complement other functional scores (eg the Lysholm knee score) for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 100 where 0 is 'on sick leave/disability' and 100 is 'participation in competitive sports at a full, unhindered level.
International Knee Documentation Committee (IKDC) at 24 Months.
The International Knee Documentation Committee scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
MRI Evaluation Score
MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00793104
Brief Title
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
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Slow enrolment & potential regulatory changes for allograft in cartilage repair
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injury
Keywords
allograft, knee injury, cartilage injury, Osteochondral defects in the articular femoral cartilage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CR Plug
Arm Type
Other
Arm Description
Placement of allograft CR Plug in primary injury site
Intervention Type
Procedure
Intervention Name(s)
Placement of allograft CR Plug in primary injury site
Intervention Description
Core defect and implant allograft CR plug
Primary Outcome Measure Information:
Title
The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months
Description
The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Current Health Assessment
Description
Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0-100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.
Time Frame
24 months, MRI only at 12 and 24 months
Title
Lysholm With Tegner Score
Description
The Tegner activity scale was designed as a score of activity level to complement other functional scores (eg the Lysholm knee score) for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 100 where 0 is 'on sick leave/disability' and 100 is 'participation in competitive sports at a full, unhindered level.
Time Frame
24 months
Title
International Knee Documentation Committee (IKDC) at 24 Months.
Description
The International Knee Documentation Committee scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Time Frame
24 months
Title
MRI Evaluation Score
Description
MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack Farr, MD, PhD
Organizational Affiliation
OrthoIndy, Inc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ralph A Gambardella, MD
Organizational Affiliation
Kerlan Jobe Orthopaedic Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stewart Weinerman, MD
Organizational Affiliation
Colorado Orthopedic Consultants
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kerlan Jobe Orthopaedic Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Colorado Orthopedic Consultants
City
Denver
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
OrthoIndy, Inc
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.orthoindy.com
Description
Click here to find more information from OrthoIndy
Learn more about this trial
Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.
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