- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01410136
Chondrofix Osteochondral Allograft Prospective Study
A Post Market Study to Evaluate the Chondrofix® Osteochondral Allograft Utilized for Treatment of Subjects With Cartilage Lesions in the Knee
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Knee cartilage injuries are a major cause of pain and functional impairment in young to middle age adults and can lead to progressive joint degeneration. In response to challenges with current cartilage repair options, Chondrofix Allograft was developed as an off-the-shelf treatment option adding to the variety of cartilage reparation offerings.
This study is a multicenter, prospective, post-market clinical outcomes study designed to assess the clinical outcomes of Chondrofix Allograft used in the treatment of both primary and revision cartilage repair cases. Study design includes up to 6 qualified investigational sites with 50 subjects enrolled across all centers during an 18 month enrollment period. Study subjects will be followed postoperatively for 5 years. The Investigators who are responsible for the conduct of this study in compliance with this protocol will be orthopedic surgeons who are skilled in the techniques of articular cartilage repair.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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Cos Cob, Connecticut, United States, 06807
- Plancher Orthopaedics and Sports Medicine
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New Haven, Connecticut, United States, 06511
- The Orthopaedic Group, LLC
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Indiana
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Greenwood, Indiana, United States, 46143
- Orthopaedic Research Foundation, Inc.
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Massachusetts
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Chestnut Hill, Massachusetts, United States, 02467
- Cartilage Repair Center, Brigham and Women's Hospital
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Ohio
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Columbus, Ohio, United States, 43215
- Specialized Orthopaedics and Sports Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Generally, the following inclusion criteria must be met, however, this is not a complete list.
- Male and non-pregnant female subjects between 18 and 70 years; subject must be skeletally mature
- If female, subjects are not pregnant at time of surgery and do not plan on becoming pregnant during the first 24 months of the study
- Up to two (2) cartilage lesion(s), each measuring less than 8 cm2, of the femoral condyle or trochlear groove of the knee
- Localized knee pain unresponsive to conservative treatment (e.g., medication, bracing, physical therapy) and/or previous surgical intervention
Exclusion Criteria:
Generally, if a potential participant meets any of the following criteria, they will not be eligible for this study. Additionally, more criteria will be evaluated to confirm eligibility as this list is not a complete list of criteria.
- Concurrent participation in another clinical trial
- Cartilage lesion location is such that the implanted graft(s) will not be adequately shouldered
- Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e., > than ICRS Grade 2 on the opposing articular surface)
- Is receiving pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition
- Subject had any other cartilage repair procedure other than debridement performed in conjunction with or 6 months prior to implantation of a Chondrofix Osteochondral Allograft
- Prior or concurrent total meniscectomy of the index knee
- Uncorrected mal-alignment of the index knee
- Have smoked or used nicotine products within the past 6 months
- Body Mass Index > 35 (BMI=kg/m2)
- Has any contraindications for MRI
- Requires any of the following concomitant procedures performed in conjunction with or has had performed within 6 months prior to implantation of a Chondrofix Allograft: distal realignment, high tibial osteotomy, ligament reconstruction, and/or patellar realignment procedure
- Septic or reactive arthritis or systemic disease (e.g., rheumatoid arthritis, gout or prior history of gout or pseudo gout)
- Sickle cell disease, hemochromatosis, or autoimmune disease
- Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer or uncontrolled diabetes
- HIV or other immune-deficient state including subject on immunosuppressant therapies
- Deficiency limiting ability to perform an objective functional assessment of the operative knee or an inability to adhere to a post-operative rehabilitation protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Chondrofix
Subjects with one or two confirmed knee articular cartilage lesion(s) each less than 8cm2, of the femoral condyle or trochlear groove
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Allogeneic, cylindrical, decellularized, osteochondral graft composed of hyaline cartilage and bone
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
KOOS Subscale
Time Frame: 24 Months
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The overall mean change from baseline to 24 months in the KOOS Pain and KOOS Function in Daily Living (ADL) subscale scores.
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24 Months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
X-ray & MRI Evaluation
Time Frame: Baseline and 1.5, 3, 6, 12, 24, & 60 months
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Baseline and 1.5, 3, 6, 12, 24, & 60 months
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IKDC Knee Examination
Time Frame: Baseline & 1.5, 3, 6, 12, 24, & 60 months
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Baseline & 1.5, 3, 6, 12, 24, & 60 months
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Subject Reported Questionnaires
Time Frame: Baseline and 1.5, 3, 6, 12, 24, 36, 48, and 60 months
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Baseline and 1.5, 3, 6, 12, 24, 36, 48, and 60 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nikesha N Harrington, Zimmer Orthobiologics, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSU2010-14B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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