DeNovo NT Longitudinal Data Collection (LDC) Knee Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post Market, Longitudinal Data Collection Study of DeNovo NT for Articular Cartilage Defects of the Knee

Conditions
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Degenerative Lesion of Articular Cartilage of Knee, Osteochondritis Dissecans

Intervention / Treatment
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* Other: DeNovo NT, Natural Tissue Graft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DeNovo NT patient<br>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<br>* DeNovo NT Natural Tissue Graft of 1 or 2 lesions up to 5 cm squared in area.<br>* Other names: DeNovo NT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean scores from patient-reported clinical outcome surveys |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of reoperations and revision surgeries |  | 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cartilage repair, Articular cartilage defects