Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01410136
Other study ID # CSU2010-14B
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT01473199 - BioPoly RS Knee Registry Study for Cartilage Defect Replacement N/A
Active, not recruiting NCT01670617 - DeNovo NT Natural Tissue Graft Stratified Knee Study N/A
Active, not recruiting NCT01347892 - DeNovo NT Ankle LDC Study N/A
Completed NCT02203071 - Comparison of BioCartilage Versus Marrow Stimulating Procedure for Cartilage Defects of the Knee
Completed NCT01626677 - Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect Phase 3
Active, not recruiting NCT02855073 - Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects Phase 2
Terminated NCT01400607 - Neocartilage Implant to Treat Cartilage Lesions of the Knee Phase 3
Completed NCT01290991 - A Study to Evaluate the Safety of Augmentâ„¢ Bone Graft N/A
Terminated NCT00881023 - Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration N/A
Terminated NCT02542566 - Protected Versus Early Weight Bearing Post Microfracture Surgery N/A
Completed NCT02696876 - Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair N/A
Active, not recruiting NCT02524509 - the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee Phase 4
Active, not recruiting NCT02537067 - Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle Phase 3
Recruiting NCT02519881 - the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Ankle Phase 4
Active, not recruiting NCT02539030 - Comparison of Efficacy and Safety of Microfracture and Modified Microfracture Phase 4
Active, not recruiting NCT02659215 - HyaloFAST Trial for Repair of Articular Cartilage in the Knee N/A
Active, not recruiting NCT00885729 - Mesenchymal Stem Cells in a Clinical Trial to Heal Articular Cartilage Defects Phase 1
Terminated NCT01246635 - Smith & Nephew's European Trufit Study N/A