NCT01329445

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 26, 2017

Status Verified

December 1, 2016

Enrollment Period

10.8 years

First QC Date

April 1, 2011

Last Update Submit

January 25, 2017

Conditions

Degenerative Lesion of Articular Cartilage of KneeOsteochondritis Dissecans

Keywords

Cartilage repairArticular cartilage defects

Outcome Measures

Primary Outcomes (1)

  • Mean scores from patient-reported clinical outcome surveys

    5 years

Secondary Outcomes (1)

  • Incidence of reoperations and revision surgeries

    5 Years

Study Arms (1)

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

DeNovo NT, Natural Tissue GraftOTHER

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

Also known as: DeNovo NT
DeNovo NT patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Specialized Orthopaedic Surgery & Spine Center

Huntsville, Alabama, 35802, United States

Location

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Colorado Orthopedic Consultants

Aurora, Colorado, 80012, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Midwest Orthopaedics at Rush Univ Hospital

Chicago, Illinois, 60612, United States

Location

OrthoIndy

Greenwood, Indiana, 46143, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

New Mexico Orthopaedic Associates

Albuquerque, New Mexico, 87106, United States

Location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Specialized Orthopaedics & Sports Medicine

Columbus, Ohio, 43215, United States

Location

Cleveland Clinic Sports Health Center

Garfield Heights, Ohio, 44125, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Jordan Young Institute

Virginia Beach, Virginia, 23462, United States

Location

Aurora Baycare Medical Center

Green Bay, Wisconsin, 54308, United States

Location

Dean Clinic

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Osteochondritis Dissecans

Condition Hierarchy (Ancestors)

OsteochondritisBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2011

First Posted

April 6, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 26, 2017

Record last verified: 2016-12

Locations

US(15)