Status:
TERMINATED
Chondrofix Osteochondral Allograft Prospective Study
Lead Sponsor:
Zimmer Orthobiologics, Inc.
Conditions:
Articular Cartilage Disorder
Degeneration; Articular Cartilage
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The overall study objective is to evaluate Chondrofix Osteochondral Allograft ("Chondrofix") for the repair of osteochondral lesions in the knee. This includes, but is not limited to primary cartilage...
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 cartila...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01410136
Start Date
April 1 2011
End Date
March 1 2014
Last Update
August 11 2014
Active Locations (5)
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1
Plancher Orthopaedics and Sports Medicine
Cos Cob, Connecticut, United States, 06807
2
The Orthopaedic Group, LLC
New Haven, Connecticut, United States, 06511
3
Orthopaedic Research Foundation, Inc.
Greenwood, Indiana, United States, 46143
4
Cartilage Repair Center, Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467