ClinicalTrials.gg
Status unknownNCT01329445Updated Jan 26, 2017

DeNovo NT Longitudinal Data Collection (LDC) Knee Study

An observational study in Degenerative Lesion of Articular Cartilage of Knee and Osteochondritis Dissecans, sponsored by Zimmer Orthobiologics, Inc.. Status unknown at 15 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this record recently (last verified Dec 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
160
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
2nd 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 2nd 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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02

Study summary

The purpose of this study is to evaluate the long-term outcomes of DeNovo NT, a tissue product used for the repair of cartilage damage in the knee. This product has been on the market since 2007 and implanted in more than 10,000 patients around the country.

Read the detailed description

Knee cartilage injury is a major cause of pain and functional impairment in young to middle age adults, and can lead to progressive joint degeneration. Adult cartilage has little regenerative capacity and many of the current treatment options have limited or unknown durability. DeNovo NT is an allogeneic tissue graft, prepared from donated juvenile cartilage, which has been shown to have a higher chondrogenic potential than adult cartilage. The graft involves a single surgery with no need for scaffolds, flaps or donor-site morbidity. This study will follow the long-term outcomes and durability of DeNovo NT in patients grafted with this product in the knee, for up to five years. It will enroll subjects prospectively (at the time of surgery) and retrospectively (those who have been previously implanted). Data will be collected on patient-reported outcomes, results of knee examinations, and reoperations and revisions.

03

Conditions studied

  • Degenerative Lesion of Articular Cartilage of Knee
  • Osteochondritis Dissecans

Keywords

  • Cartilage repair
  • Articular cartilage defects
04

Who can participate

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

Study population

Patients being recommended for arthroscopic or surgical intervention for articular cartilage lesionis of the knee

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.

Inclusion criteria

  • Has a contained articular cartilage lesion(s) of the knee or Osteochondritis Dissecans OCD lesion(s) of the knee for which arthroscopic or surgical intervention is warranted, OR Has had prior treatment with DeNovo NT for a contained articulare cartilage lesion(so of the knee or Osteochondritis Dissecans OCD lesion(s) of the knee
  • 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 years
  • 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 damage to the subchondral bone that has not/will not be repaired prior to DeNovo NT treatment
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
160 participants (actual)

Groups and cohorts

  • DeNovo NT patient

    Patients who have received or who are scheduled to receive a DeNovo NT graft for repair of 1-2 knee cartilage lesions.

    Other: DeNovo NT, Natural Tissue Graft

Interventions

  • OtherDeNovo NT, Natural Tissue Graft

    DeNovo NT Natural Tissue Graft of 1 or 2 lesions up to 5 cm squared in area.

    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

15 sites
  • Specialized Orthopaedic Surgery & Spine Center
    Huntsville, Alabama 35802, United States
  • Naval Medical Center San Diego
    San Diego, California 92134, United States
  • Colorado Orthopedic Consultants
    Aurora, Colorado 80012, United States
  • Emory University
    Atlanta, Georgia 30329, United States
  • Midwest Orthopaedics at Rush Univ Hospital
    Chicago, Illinois 60612, United States
  • OrthoIndy
    Greenwood, Indiana 46143, United States
  • Sinai Hospital of Baltimore
    Baltimore, Maryland 21215, United States
  • New Mexico Orthopaedic Associates
    Albuquerque, New Mexico 87106, United States
  • OrthoCarolina Research Institute
    Charlotte, North Carolina 28207, United States
  • Specialized Orthopaedics & Sports Medicine
    Columbus, Ohio 43215, United States
  • Cleveland Clinic Sports Health Center
    Garfield Heights, Ohio 44125, United States
  • University of Virginia
    Charlottesville, Virginia 22903, United States
  • Jordan Young Institute
    Virginia Beach, Virginia 23462, United States
  • Aurora Baycare Medical Center
    Green Bay, Wisconsin 54308, United States
  • Dean Clinic
    Madison, Wisconsin 53715, United States
08

Timeline

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

The record gives a start of Feb 2011, a primary completion of Dec 2021 and a completion of Dec 2021. 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
Apr 1, 2011
First posted
Apr 6, 2011
Start
Feb 2011
Primary completionEst.
Dec 2021
CompletionEst.
Dec 2021
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 ↗
09

Registry details

Key details

Study ID
NCT01329445
Responsible party
Sponsor
First posted
Apr 6, 2011
Start date
Feb 2011
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (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 Dec 2016. You cannot join it, but the record below documents what was studied.

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