Chondrofix Osteochondral Allograft Prospective Study

Defect of Articular Cartilage Clinical Trial

Official title:

A Post Market Study to Evaluate the Chondrofix® Osteochondral Allograft Utilized for Treatment of Subjects With Cartilage Lesions in the Knee

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01410136
• Other study ID #: CSU2010-14B
• Status: Terminated
• Phase: N/A
• First received: August 2, 2011
• Last updated: August 7, 2014
• Start date: April 2011
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: Zimmer Orthobiologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Chondrofix Osteochondral Allograft
Allogeneic, cylindrical, decellularized, osteochondral graft composed of hyaline cartilage and bone

Locations

Country	Name	City	State
United States	Cartilage Repair Center, Brigham and Women's Hospital	Chestnut Hill	Massachusetts
United States	Specialized Orthopaedics and Sports Medicine	Columbus	Ohio
United States	Plancher Orthopaedics and Sports Medicine	Cos Cob	Connecticut
United States	Orthopaedic Research Foundation, Inc.	Greenwood	Indiana
United States	The Orthopaedic Group, LLC	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Orthobiologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	X-ray & MRI Evaluation		Baseline and 1.5, 3, 6, 12, 24, & 60 months	No
Secondary	IKDC Knee Examination		Baseline & 1.5, 3, 6, 12, 24, & 60 months	No
Secondary	Subject Reported Questionnaires		Baseline and 1.5, 3, 6, 12, 24, 36, 48, and 60 months	No