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 range18 Years

SexALL

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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

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