UnknownNot Applicable

DeNovo NT Longitudinal Data Collection (LDC) Knee Study

United States160 participantsStarted 2011-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Informed Consent * 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: * 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 damage to the subchondral bone that has not/will not be repaired prior to DeNovo NT treatment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean scores from patient-reported clinical outcome surveys

Timeframe: 5 years

Trial details

NCT IDNCT01329445

SponsorZimmer Orthobiologics, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-12

View on ClinicalTrials.gov More Degenerative Lesion of Articular Cartilage of Knee trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.