ClinicalTrials.gg
Status unknownNCT01347892Updated Jan 26, 2017

DeNovo NT Ankle LDC Study

An observational study in Defect of Articular Cartilage, Osteochondral Lesion of Talus and Osteochondritis Dissecans, sponsored by Zimmer Orthobiologics, Inc.. Status unknown at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-26.

Sponsored by Zimmer Orthobiologics, Inc. (part of Zimmer Biomet) · Observational

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
205
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Osteochondritis Dissecans with a site in United States — 4 open to participants now, 4 under way, 1 of them phase 3. Osteochondritis Dissecans · United States.

Started
2011
with 3 others
Observational
6 of 13
1 open now
Registered
3rd of 13
by date
Lead sponsor
3 of 13
Zimmer Orthobiologics, Inc.

Among the 13 studies in Osteochondritis Dissecans with a site in United States, this one is one of 4 that started in 2011, is one of 6 observational ones, and was the 3rd registered.

Osteochondritis Dissecans

30 studies on the registry are indexed under Osteochondritis Dissecans; 7 are open to participants now.

Browse Osteochondritis Dissecans studies →

Open to participants now

4 of the 13 studies in Osteochondritis Dissecans with a site in United States are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 6 Osteochondritis Dissecans studies recruiting now, 2 set no upper age limit and 4 stop at 75 or younger; 5 take children under 18; none take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Osteochondritis Dissecans with a site in United States, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Defect of Articular Cartilage
  • Osteochondral Lesion of Talus
  • Osteochondritis Dissecans

Keywords

  • Talar injury
  • ankle
  • lesion
  • defect
  • cartilage repair
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • 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

Exclusion Criteria:

  • Displays a high surgical risk as determined by the investigative surgeon
  • Is pregnant or breast-feeding
  • Has a clinically diagnosed 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
205 participants (actual)

Groups and cohorts

  • 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

Interventions

  • OtherDeNovo 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

    Also known as: DeNovo NT

06

What researchers measure

Primary outcomes

  1. Mean scores from patient-reported clinical outcome surveys

    Time frame: 5 years

Secondary outcomes

  1. Incidence of reoperations and revision surgeries

    Time frame: 5 years

07

Study locations

8 sites
  • University of California, Davis at UC Davis Medical Center
    Sacramento, California 95817, United States
  • Tripler Army Medical Center
    Honolulu, Hawaii 96859, United States
  • MedStar Health Research Institute at Union Memorial Hospital
    Baltimore, Maryland 21218, United States
  • Minnesota Orthopedic Sports Medicine Institue at Twin Cities Orthopedics
    Edina, Minnesota 55435, United States
  • OhioHealth Research Institute at Orthopedic Foot & Ankle Center
    Westerville, Ohio 43082, United States
  • San Antonio Military Medical Center/Brooke Army Medical Center
    Ft Sam Houston, Texas 78248, United States
  • The Orthopaedic Foot & Ankle Center of Washington
    Falls Church, Virginia 22042, United States
  • Madigan Army Medical Center
    Tacoma, Washington 98431, United States
08

References and documents

Publications

  • Coetzee JC, Giza E, Schon LC, Berlet GC, Neufeld S, Stone RM, Wilson EL. Treatment of osteochondral lesions of the talus with particulated juvenile cartilage. Foot Ankle Int. 2013 Sep;34(9):1205-11. doi: 10.1177/1071100713485739. Epub 2013 Apr 10. PubMed 23576118 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2011, a primary completion of Jul 2019 and a completion of Sep 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 3, 2011
First posted
May 5, 2011
Start
Mar 2011
Primary completionEst.
Jul 2019
CompletionEst.
Sep 2019
Last update
Jan 26, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01347892
Responsible party
Sponsor
First posted
May 5, 2011
Start date
Mar 2011
Primary completion
Jul 2019 (estimated)
Completion
Sep 2019 (estimated)
Last update
Jan 26, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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