Chondrofix Osteochondral Allograft Prospective Study

This study has been terminated.
(Inadequate enrollment and decreased need for clinical data to support product)
Sponsor:
Information provided by (Responsible Party):
Zimmer Orthobiologics, Inc.
ClinicalTrials.gov Identifier:
NCT01410136
First received: August 2, 2011
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Articular Cartilage Disorder
Degeneration; Articular Cartilage
Chronic Cartilage Injury
Acute Cartilage Injury
Defect of Articular Cartilage
Procedure: Chondrofix Osteochondral Allograft

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Post Market Study to Evaluate the Chondrofix® Osteochondral Allograft Utilized for Treatment of Subjects With Cartilage Lesions in the Knee

Resource links provided by NLM:


Further study details as provided by Zimmer Orthobiologics, Inc.:

Primary Outcome Measures:
  • KOOS Subscale [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    The overall mean change from baseline to 24 months in the KOOS Pain and KOOS Function in Daily Living (ADL) subscale scores.


Secondary Outcome Measures:
  • X-ray & MRI Evaluation [ Time Frame: Baseline and 1.5, 3, 6, 12, 24, & 60 months ] [ Designated as safety issue: No ]
  • IKDC Knee Examination [ Time Frame: Baseline & 1.5, 3, 6, 12, 24, & 60 months ] [ Designated as safety issue: No ]
  • Subject Reported Questionnaires [ Time Frame: Baseline and 1.5, 3, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: April 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Chondrofix
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
Allogeneic, cylindrical, decellularized, osteochondral graft composed of hyaline cartilage and bone
Other Name: Chondrofix

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410136

Locations
United States, Connecticut
Plancher Orthopaedics and Sports Medicine
Cos Cob, Connecticut, United States, 06807
The Orthopaedic Group, LLC
New Haven, Connecticut, United States, 06511
United States, Indiana
Orthopaedic Research Foundation, Inc.
Greenwood, Indiana, United States, 46143
United States, Massachusetts
Cartilage Repair Center, Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
United States, Ohio
Specialized Orthopaedics and Sports Medicine
Columbus, Ohio, United States, 43215
Sponsors and Collaborators
Zimmer Orthobiologics, Inc.
Investigators
Study Chair: Nikesha N Harrington Zimmer Orthobiologics, Inc.
  More Information

No publications provided

Responsible Party: Zimmer Orthobiologics, Inc.
ClinicalTrials.gov Identifier: NCT01410136     History of Changes
Other Study ID Numbers: CSU2010-14B
Study First Received: August 2, 2011
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Zimmer Orthobiologics, Inc.:
Knee
Femur
Articular cartilage
Lesions
Defects
Osteochondral graft
Cartilage treatments
Osteochondritis Dissecans
OCD

Additional relevant MeSH terms:
Cartilage Diseases
Wounds and Injuries
Musculoskeletal Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on August 19, 2014