DeNovo NT Natural Tissue Graft Stratified Knee Study

NCT01670617 | Unknown

• 1 other identifier: CSU2011-03B
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 18

Brief Summary

The purpose of this study is to evaluate the long-term relief of pain and return to function for patients receiving DeNovo NT for cartilage lesions in the knee. DeNovo NT is a marketed product and has been used in more than 7,500 patients over the last 7 years.

Conditions

Defect of Articular Cartilage; Knee Injuries

Outcome Measures

Primary Outcomes (1)

• Improvement in KOOS scores

  Improvement in Knee Injury and Osteoarthritis Outcomes Survey (KOOS) scores

  Between baseline and 24 months post surgery

Secondary Outcomes (5)

• X-ray Evaluation

  Preop, 12 months and 24 months post surgery

• Incidence and time to reoperation/revision

  5 years

• Mean IKDC Knee Examination grades

  Annually to 5 years post surgery

• MRI Evaluation

  Preop, 12 Months and 24 Months post surgery

• Incidence of adverse events

  Annually to 5 years post surgery

Study Arms (1)

DeNovo NT Graft

OTHER

DeNovo NT Graft stratified by lesion location - femur or patella

Other: Particulated Juvenile Articular Cartilage

Interventions

Particulated Juvenile Articular Cartilage OTHER

Treatment of articular cartilage defects up to 7.5 cm2

Also known as: DeNovo NT Natural Tissue Graft

DeNovo NT Graft

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntary signature of the IRB approved Informed Consent,
• Male or female subjects between the ages of 18 to 55 years,
• If female: Actively practicing a contraception method and willing to continue for a minimum of 1 year postoperatively, practicing abstinence and willing to continue for a minimum of 1 year postoperatively, or sterile
• One or two contained lesion(s) of the femur or patella ≥ ICRS Grade 3 or OCD lesions with healed bone base with no loss of bone greater than 6mm
• Has peripheral cartilage debridement to healthy cartilage that results in at least one lesion with an area of ≥ 2 cm2 and ≤ 7.5 cm2,
• Lesion(s) to be treated must be contained/shouldered \> 70% of the periphery,
• Ligaments in the affected knee are stable,
• Ipsilateral knee compartment has intact menisci
• The contralateral knee is asymptomatic, stable, and fully functional,
• Is refractory to conservative non-surgical management or minimal surgical intervention and ≥ 3 months from the start of either treatment,
• Must record a response, at the preoperative study visit, of moderate to extreme pain for any one of the KOOS Pain Scale questions, P2 through P9.
• Must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol

You may not qualify if:

• Clinical disease diagnosis of the indexed affected joint that includes
• Osteoarthritis or avascular necrosis,
• Rheumatoid arthritis, or history of septic or reactive arthritis,
• Gout or a history of gout or pseudogout in the affected knee,
• Bipolar articular cartilage involvement (or kissing lesions)
• Has more than two clinically relevant chondral lesion(s) on the index knee,
• Osteochondritis dissecans of the knee with significant bone loss
• Associated damage to the underlying subchondral bone requiring bone graft,
• Has well-defined subchondral cyst(s),
• Has current or impending subchondral avascular necrosis,
• History of secondary arthropathies (i.e., sickle cell disease, hemochromatosis, or autoimmune disease),
• Uncontrolled diabetes,
• Displays a high surgical risk due to unstable cardiac and/or pulmonary disease,
• Has HIV or other immunodeficient state
• Is at substantial risk for the need of organ transplantation

Sponsors & Collaborators

• Zimmer Orthobiologics, Inc.: lead

Study Sites (18)

Kerlan Jobe Orthopaedics

Los Angeles, California, 90045, United States

Location

Naval Medical Center San Deigo

San Deigo, California, 92134, United States

Location

Colorado Orthopedic Consultants

Aurora, Colorado, 80012, United States

Location

Andrews Institute for Orthopaedics & Sports Medicine

Gulf Breeze, Florida, 32561, United States

Location

Emory Spine & Sports Medicine Center

Atlanta, Georgia, 30329, United States

Location

Tulane University Medical Center

New Orleans, Louisiana, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

TRIA Orthopaedic Center

Bloomington, Minnesota, 55431, United States

Location

Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics

Edina, Minnesota, 55435, United States

Location

A.T. Still University of Health Sciences

Kirksville, Missouri, 63501, United States

Location

University Orthopaedic Associates

Somerset, New Jersey, 08873, United States

Location

New Mexico Orthopaedic Consultants

Albuquerque, New Mexico, 87106, United States

Location

Oregon Health & Science University

Portland, Oregon, 97201, United States

Location

San Antonio Military Medical Center

San Antonio, Texas, 78234, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Ottawa Hospital

Ottawa, Ontario, Canada

Location

Women's College Hospital

Toronoto, M5S 1B1, Canada

Location

Related Publications (1)

• Farr J, Cole BJ, Sherman S, Karas V. Particulated articular cartilage: CAIS and DeNovo NT. J Knee Surg. 2012 Mar;25(1):23-9. doi: 10.1055/s-0031-1299652.

  PMID: 22624244 BACKGROUND

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 22, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2021
• Last Updated: January 26, 2017

Record last verified: 2016-12

Locations

CA (2); US (16)