DeNovo NT Longitudinal Data Collection (LDC) Knee Study

Osteochondritis Dissecans Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01329445
• Other study ID #: CSU2010-22B
• Status: Active, not recruiting
• Phase: N/A
• First received: April 1, 2011
• Last updated: January 25, 2017
• Start date: February 2011
• Est. completion date: December 2021

Study information

• Verified date: December 2016
• Source: Zimmer Orthobiologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Lesion of Articular Cartilage of Knee
• Osteochondritis
• Osteochondritis Dissecans

Intervention

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

Locations

Country	Name	City	State
United States	New Mexico Orthopaedic Associates	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	Colorado Orthopedic Consultants	Aurora	Colorado
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	OrthoCarolina Research Institute	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Midwest Orthopaedics at Rush Univ Hospital	Chicago	Illinois
United States	Specialized Orthopaedics & Sports Medicine	Columbus	Ohio
United States	Cleveland Clinic Sports Health Center	Garfield Heights	Ohio
United States	Aurora Baycare Medical Center	Green Bay	Wisconsin
United States	OrthoIndy	Greenwood	Indiana
United States	Specialized Orthopaedic Surgery & Spine Center	Huntsville	Alabama
United States	Dean Clinic	Madison	Wisconsin
United States	Naval Medical Center San Diego	San Diego	California
United States	Jordan Young Institute	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Orthobiologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean scores from patient-reported clinical outcome surveys		5 years
Secondary	Incidence of reoperations and revision surgeries		5 Years