Back to resultsEvaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects
Primary Purpose
Knee Injury
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Primary injury site
Backfill site
Sponsored by
About this trial
This is an interventional treatment trial for Knee Injury focused on measuring allograft, knee injury, cartilage injury
Eligibility Criteria
Inclusion Criteria:
- 18 to 55 years
- skeletally mature
- Have a symptomatic score International Cartilage Repair Society (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle or Lateral Femoral Condyle. Symptoms must include pain, pain with weight bearing and squatting, locking of joints and or swelling
- Functional meniscal tissue (defined as 5 mmor greater)
- 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 on 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 year prior to current study
- Previous surgical meniscus treatment 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 within 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
- Microfracture less than one year prior to current study
Sites / Locations
- Ellis and Badenhausen Orthopaedics, PSC
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Primary injury site
Backfill site
Arm Description
CR-Plug will be placed in the site of the primary injury
Autograft will be placed in the site of the primary injury; CR Plug will be placed in the harvest site
Outcomes
Primary Outcome Measures
Knee Injury and Osteoarthritis Outcome Score (KOOS
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 (CHA)
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.
IKDC Assessment
The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score,
Magnetic Resonance Imaging (MRI) Results
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.
Lysholm Score at 24 Months
The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00984594
Brief Title
Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects
Official Title
Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Osteochondral Defects in High-Load-Bearing Region and Low-Load-Bearing Region of the Femoral Condyle
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Slow enrolment & potential regulatory changes for allograft in cartilage repair
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 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 objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment of smaller, focal defects (like the injury the patient has to their knee).
Detailed Description
The main objective of this double arm study is to test the ability of an allograft plug to provide "successful" repair of less than (<) 2.5 cm2 osteochondral defect in a low-load-bearing femoral condyle region, and a high-load-bearing femoral-condyle region.
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary injury site
Arm Type
Other
Arm Description
CR-Plug will be placed in the site of the primary injury
Arm Title
Backfill site
Arm Type
Other
Arm Description
Autograft will be placed in the site of the primary injury; CR Plug will be placed in the harvest site
Intervention Type
Other
Intervention Name(s)
Primary injury site
Intervention Description
Autograft will be placed in the primary defect site.
Intervention Type
Other
Intervention Name(s)
Backfill site
Intervention Description
Autograft will be placed in the primary defect site; CR-Plug will be placed in the harvest site.
Primary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS
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 (CHA)
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
Title
IKDC Assessment
Description
The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score,
Time Frame
24 months
Title
Magnetic Resonance Imaging (MRI) Results
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
Title
Lysholm Score at 24 Months
Description
The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.
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
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 to 55 years
skeletally mature
Have a symptomatic score International Cartilage Repair Society (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle or Lateral Femoral Condyle. Symptoms must include pain, pain with weight bearing and squatting, locking of joints and or swelling
Functional meniscal tissue (defined as 5 mmor greater)
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 on 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 year prior to current study
Previous surgical meniscus treatment 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 within 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
Microfracture less than one year prior to current study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akbar Nawab, MD
Organizational Affiliation
Ellis and Badenhausen Orthopaedics, PSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ellis and Badenhausen Orthopaedics, PSC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
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Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects
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