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Sponsored by: |
Zimmer, Inc. |
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Information provided by: | Zimmer, Inc. |
ClinicalTrials.gov Identifier: | NCT00791245 |
The purpose of this post market study is to evaluate surgical implantation technique and the quality of repair of the cartilage defect with particulated juvenile cartilage in the human knee joint.
Condition | Intervention |
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Cartilage Repair |
Biological: Particulated Juvenile Cartilage Allograft |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | A Post Market Study of Articular Cartilage Defects of the Knee Treated Wtih DeNovo NT, Natural Tissue Graft |
Estimated Enrollment: | 25 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
1
DeNovo NT
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Biological: Particulated Juvenile Cartilage Allograft
Particulated Juvenile Cartilage Allograft
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The intent of this post market study is to assess the clinical outcomes of DeNovo NT, a particulated juvenile cartilage tissue for the treatment of one or two contained lesion(s) equal to an ICRS Grade 3a, 3b, 3c, 3d of the femoral condyle or trochlear groove and OCD lesions (Grade 4a) with healed bone base, which is non sclerotic and no loss of bone greater thank 6mm measured from the surrounding subchondral plate.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Clinical population
Inclusion Criteria:
If female:
Exclusion Criteria:
Clinical and/or radiographic disease diagnosis of the indexed affected joint that includes:
Contact: Sandra Navarrete, BS | sandra.navarrete@zimmer.com | |
Contact: Pat Reischling, MSB, CCRA | pat.reischling@zimmer.com |
United States, Alabama | |
University of South Alabama Medical Center | Not yet recruiting |
Mobile, Alabama, United States, 36693 | |
Contact: Carmen May, NP 251-665-8200 | |
Principal Investigator: Albert Pearsall, MD | |
United States, California | |
Shiley Center for Orhtopaedics | Not yet recruiting |
La Jolla, California, United States, 92037 | |
Contact: Suzanne Daneshvari, BSN 858-332-0133 daneshvari.suzanne@scrippshealth.org | |
Principal Investigator: William Bugbee, MD | |
United States, Illinois | |
Midwest Orthopaedics at Rush | Not yet recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Mukesh Ahuja, MD 312-361-2152 mahuja@rushortho.com | |
Principal Investigator: Brian Cole, MD | |
United States, Indiana | |
OrthoIndy | Recruiting |
Indianapolis, Indiana, United States, 46237 | |
Contact: Vicki Snodgrass, CCRC 317-884-5230 vsnodgrass@orthoindy.com | |
Principal Investigator: Jack Farr, MD | |
United States, New Mexico | |
Cartilage Restoration Center of New Mexico | Not yet recruiting |
Albuquerque, New Mexico, United States, 87106 | |
Contact: Ashley Wise 505-220-6964 wisea@nmortho.net | |
Principal Investigator: Samuel Tabet, MD |
Responsible Party: | Zimmer, Inc ( Sandra Navarrete, CRA ) |
Study ID Numbers: | ISTO - DeNovo NT 03-07-02 |
Study First Received: | November 13, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00791245 |
Health Authority: | United States: Institutional Review Board |
ISTO Technologies, Inc cartilage repair arthroscopy 361 HCT/P |
human tissue biologic knee |