DeNovo NT Ankle LDC Study

Sponsor

Zimmer Orthobiologics, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01347892

Collaborator

(none)

205

Enrollment

Locations

102

Duration (Months)

25.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Defect of Articular Cartilage Osteochondral Lesion of Talus Osteochondritis Dissecans	Other: DeNovo NT Natural Tissue Graft

Detailed 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

Study Type:

Observational

Actual Enrollment :

205 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Post Market, Longitudinal Data Collection Study of Articular Cartilage Lesions in the Ankle Treated With DeNovo(R) NT Natural Tissue Graft

Study Start Date :

Mar 1, 2011

Anticipated Primary Completion Date :

Jul 1, 2019

Anticipated Study Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
DeNovo NT Subject Subjects who have received or who are scheduled to receive a DeNovo NT Graft for repair of a cartilage lesion in the ankle.	Other: DeNovo NT Natural Tissue Graft DeNovo NT is a juvenile cartilagenous tissue graft, inclusive of a viable human cartilage cells. It is provided as particulated tissue pieces of approximately 1mm3 each Other Names: DeNovo NT

Arm

Intervention/Treatment

DeNovo NT Subject

Subjects who have received or who are scheduled to receive a DeNovo NT Graft for repair of a cartilage lesion in the ankle.

Other: DeNovo NT Natural Tissue Graft

DeNovo NT is a juvenile cartilagenous tissue graft, inclusive of a viable human cartilage cells. It is provided as particulated tissue pieces of approximately 1mm3 each

Other Names:

DeNovo NT

Outcome Measures

Primary Outcome Measures

Mean scores from patient-reported clinical outcome surveys [5 years]

Secondary Outcome Measures

Incidence of reoperations and revision surgeries [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Potential subjects are screened for study entry based on a preliminary review of the inclusion and exclusion criteria as it applies to their pre-operative status (unless otherwise noted).

Inclusion Criteria:

Has an articular cartilage lesion(s) in the ankle for which arthroscopic or surgical intervention with DeNovo NT Graft is warranted or has had prior treatment with DeNovo NT Graft for an articular cartilage lesion(s) in the ankle
Has voluntarily signed the IRB approved informed consent
Is of stable health and is able to undergo surgery
Is male or female over the age of 18 at the time of consent
Is physically and mentally willing and able to comply with post-operative rehabilitation and routinely scheduled clinical visits.

Exclusion Criteria:

Displays a high surgical risk as determined by the investigative surgeon
Is pregnant or breast-feeding
Has a clinically diagnosed autoimmune disease
Has an active joint infection or history of chronic joint infection at the surgical site
Has medical history that would likely make the subject unreliable for the study, or any combination of variables in the investigator's judgment that should exclude a potential subject

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Davis at UC Davis Medical Center	Sacramento	California	United States	95817
2	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859
3	MedStar Health Research Institute at Union Memorial Hospital	Baltimore	Maryland	United States	21218
4	Minnesota Orthopedic Sports Medicine Institue at Twin Cities Orthopedics	Edina	Minnesota	United States	55435
5	OhioHealth Research Institute at Orthopedic Foot & Ankle Center	Westerville	Ohio	United States	43082
6	San Antonio Military Medical Center/Brooke Army Medical Center	Ft Sam Houston	Texas	United States	78248
7	The Orthopaedic Foot & Ankle Center of Washington	Falls Church	Virginia	United States	22042
8	Madigan Army Medical Center	Tacoma	Washington	United States	98431