DeNovo NT Natural Tissue Graft Stratified Knee Study

Not Applicable

• Conditions: Defect of Articular Cartilage; Knee Injuries

• Registration Number: NCT01670617
• Lead Sponsor: Zimmer Orthobiologics, Inc.

Brief Summary

The purpose of this study is to evaluate the long-term relief of pain and return to function for patients receiving DeNovo NT for cartilage lesions in the knee. DeNovo NT is a marketed product and has been used in more than 7,500 patients over the last 7 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-22
• Status Verified: 2016-12
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26
• Primary Completion: 2018-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement in KOOS scores	Between baseline and 24 months post surgery	Improvement in Knee Injury and Osteoarthritis Outcomes Survey (KOOS) scores

Secondary Outcome Measures

Name	Time	Method
Incidence and time to reoperation/revision	5 years
Mean IKDC Knee Examination grades	Annually to 5 years post surgery
X-ray Evaluation	Preop, 12 months and 24 months post surgery	X-ray evaluation of joint narrowing, and osteophyte and cyst formation
MRI Evaluation	Preop, 12 Months and 24 Months post surgery	Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
Incidence of adverse events	Annually to 5 years post surgery

Trial Locations

Locations (18)

Kerlan Jobe Orthopaedics; 🇺🇸 Los Angeles, California, United States

Naval Medical Center San Deigo; 🇺🇸 San Deigo, California, United States

Colorado Orthopedic Consultants; 🇺🇸 Aurora, Colorado, United States

Andrews Institute for Orthopaedics & Sports Medicine; 🇺🇸 Gulf Breeze, Florida, United States

Emory Spine & Sports Medicine Center; 🇺🇸 Atlanta, Georgia, United States

Tulane University Medical Center; 🇺🇸 New Orleans, Louisiana, United States

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

TRIA Orthopaedic Center; 🇺🇸 Bloomington, Minnesota, United States

Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics; 🇺🇸 Edina, Minnesota, United States

A.T. Still University of Health Sciences; 🇺🇸 Kirksville, Missouri, United States

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