DeNovo NT Ankle LDC Study

Status Active, not recruiting

Clinical Trial Summary

The purpose of this post-market clinical study is to collect long-term outcomes for DeNovo NT Graft treatment of articular cartilage lesions in the ankle in a standard clinical setting. Outcomes to be assessed include pain, function, activity levels and healthcare resource use.

Clinical Trial Description

Articular cartilage lesions in the ankle can cause significant pain and loss of function for young to middle age adults. There are several treatment options for symptomatic articular cartilage injuries depending on a patient's age, symptoms and duration of complaints in addition to the size and condition of the lesion. DeNovo NT Natural Tissue Graft is comprised of fresh particulated juvenile cartilage pieces that are secured inside articular cartilage lesions using fibrin adhesive. DeNovo NT Graft was developed due to the current need for expanded treatment options for the treatment of cartilage lesions, especially large lesions.

This post-market, multicenter, longitudinal data collection study was established to collect clinical outcomes of subjects implanted with DeNovo NT Graft. Data may be obtained either retrospectively or prospectively from patients implanted or to be implanted with DeNovo NT Graft for the treatment of lesion in the ankle. Data to be collected include details of the operative procedure as well as subject pain, function, activity levels, and healthcare resource use through a five year post-operative follow-up period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01347892
Study type	Observational
Source	Zimmer Orthobiologics, Inc.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 2011
Completion date	September 2019

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT01458782` - ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of Cartilage Defects in the Knee	N/A
Active, not recruiting	`NCT02771496` - Osteochondritis Dissecans of Knee Prospective Cohort
Completed	`NCT02397278` - Intra Articular Injections With Platelet Rich Plasma in Patients With Juvenile Osteochondritis Dissecans of the Knee	N/A
Recruiting	`NCT01409447` - Repair of Articular Osteochondral Defect	N/A
Active, not recruiting	`NCT03656185` - Elbow Arthroscopy Data Analysis
Not yet recruiting	`NCT06462040` - Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee Joint
Completed	`NCT01471236` - Evaluation of the Agili-C Biphasic Implant in the Knee Joint	N/A
Enrolling by invitation	`NCT01455987` - Osteochondritis Dissecans of the Knee	N/A
Recruiting	`NCT01159899` - Transplantation of Bone Marrow Stem Cells Stimulated by Proteins Scaffold to Heal Defects Articular Cartilage of the Knee	Phase 0
Terminated	`NCT00881023` - Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration	N/A
Recruiting	`NCT04364334` - Knee Registry (Knieregister)
Recruiting	`NCT01498029` - Knee Articular Cartilage Repair: Cartilage Autograft Implantation System Versus Conventional Microfracture	Phase 3
Completed	`NCT03452098` - Post-Operative Rehabilitation of Knee Osteochondral Defect: A Case Series
Completed	`NCT04297449` - Prospective 2-year Data Collection of the First 10 Patients After Ankle Spacer Implantation
Suspended	`NCT02664337` - Conjoint Analysis of Patient Preferences in Joint Interventions	N/A
Active, not recruiting	`NCT01329445` - DeNovo NT Longitudinal Data Collection (LDC) Knee Study	N/A
Completed	`NCT02993510` - A Randomized Controlled Trial Comparing Chondro-Gide® to Microfracture Alone for Treatment of Knee Cartilage Defects.	Phase 3
Recruiting	`NCT01694823` - Safety and Efficacy Study of Cells Sheet-Autologous Chondrocyte Implantation to Treat Articular Cartilage Defects	Phase 1/Phase 2
Withdrawn	`NCT01283737` - Use of Demineralised Bone Matrix (DBX) in Osteochondritis Dissecans (OCD)	Phase 4