Chondrofix Osteochondral Allograft Prospective Study

NCT01410136 | Terminated

• 1 other identifier: CSU2010-14B
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 5

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 lesion repair and revision of failed prior cartilage repair treatments. The study hypothesis is that Chondrofix Allograft will provide pain relief and functional improvement as demonstrated by a comparative analysis of baseline clinical evaluations at 24 months of follow-up.

Conditions

Articular Cartilage Disorder; Degeneration; Articular Cartilage; Chronic Cartilage Injury; Acute Cartilage Injury; Defect of Articular Cartilage

Keywords

Knee; Femur; Articular cartilage; Lesions; Defects; Osteochondral graft; Cartilage treatments; Osteochondritis Dissecans; OCD

Outcome Measures

Primary Outcomes (1)

• KOOS Subscale

  The overall mean change from baseline to 24 months in the KOOS Pain and KOOS Function in Daily Living (ADL) subscale scores.

  24 Months

Secondary Outcomes (3)

• X-ray & MRI Evaluation

  Baseline and 1.5, 3, 6, 12, 24, & 60 months

• IKDC Knee Examination

  Baseline & 1.5, 3, 6, 12, 24, & 60 months

• Subject Reported Questionnaires

  Baseline and 1.5, 3, 6, 12, 24, 36, 48, and 60 months

Study Arms (1)

Chondrofix

OTHER

Subjects with one or two confirmed knee articular cartilage lesion(s) each less than 8cm2, of the femoral condyle or trochlear groove

Procedure: Chondrofix Osteochondral Allograft

Interventions

Chondrofix Osteochondral Allograft PROCEDURE

Allogeneic, cylindrical, decellularized, osteochondral graft composed of hyaline cartilage and bone

Also known as: Chondrofix

Chondrofix

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Orthobiologics, Inc.: lead

Study Sites (5)

Plancher Orthopaedics and Sports Medicine

Cos Cob, Connecticut, 06807, United States

Location

The Orthopaedic Group, LLC

New Haven, Connecticut, 06511, United States

Location

Orthopaedic Research Foundation, Inc.

Greenwood, Indiana, 46143, United States

Location

Cartilage Repair Center, Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

Specialized Orthopaedics and Sports Medicine

Columbus, Ohio, 43215, United States

Location

MeSH Terms

Conditions

Osteochondritis Dissecans

Condition Hierarchy (Ancestors)

Osteochondritis; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Nikesha N Harrington

  Zimmer Orthobiologics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 4, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 11, 2014

Record last verified: 2014-08

Locations

US (5)