DeNovo NT Natural Tissue Graft Stratified Knee Study

A Stratified, Post-Market Study of DeNovo NT for the Treatment of Femoral and Patellar Articular Cartilage Lesions of the Knee

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.

Study Overview

• Status: Unknown
• Conditions: Knee Injuries; Defect of Articular Cartilage
• Intervention / Treatment: Other: Particulated Juvenile Articular Cartilage

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Toronoto, Canada, M5S 1B1
    • Women's College Hospital
  • Ontario
    • Ottawa, Ontario, Canada
      • Ottawa Hospital
• United States
  • California
    • Los Angeles, California, United States, 90045
      • Kerlan Jobe Orthopaedics
    • San Deigo, California, United States, 92134
      • Naval Medical Center San Deigo
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Colorado Orthopedic Consultants
  • Florida
    • Gulf Breeze, Florida, United States, 32561
      • Andrews Institute for Orthopaedics & Sports Medicine
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory Spine & Sports Medicine Center
  • Louisiana
    • New Orleans, Louisiana, United States
      • Tulane University Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • TRIA Orthopaedic Center
    • Edina, Minnesota, United States, 55435
      • Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics
  • Missouri
    • Kirksville, Missouri, United States, 63501
      • A.T. Still University of Health Sciences
  • New Jersey
    • Somerset, New Jersey, United States, 08873
      • University Orthopaedic Associates
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • New Mexico Orthopaedic Consultants
  • Oregon
    • Portland, Oregon, United States, 97201
      • Oregon Health & Science University
  • Texas
    • San Antonio, Texas, United States, 78234
      • San Antonio Military Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
  • Washington
    • Tacoma, Washington, United States, 98431
      • Madigan Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA:

1. Voluntary signature of the IRB approved Informed Consent,
2. Male or female subjects between the ages of 18 to 55 years,
3. 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
4. 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
5. Has peripheral cartilage debridement to healthy cartilage that results in at least one lesion with an area of ≥ 2 cm2 and ≤ 7.5 cm2,
6. Lesion(s) to be treated must be contained/shouldered > 70% of the periphery,
7. Ligaments in the affected knee are stable,
8. Ipsilateral knee compartment has intact menisci
9. The contralateral knee is asymptomatic, stable, and fully functional,
10. Is refractory to conservative non-surgical management or minimal surgical intervention and ≥ 3 months from the start of either treatment,
11. 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.
12. Must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol

EXCLUSION CRITERIA:

1. 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,
2. History of secondary arthropathies (i.e., sickle cell disease, hemochromatosis, or autoimmune disease),
3. Uncontrolled diabetes,
4. Displays a high surgical risk due to unstable cardiac and/or pulmonary disease,
5. Has HIV or other immunodeficient state
6. Is at substantial risk for the need of organ transplantation
7. Is pregnant or breast-feeding,
8. Body Mass Index >35 (BMI=kg/m2),
9. Is participating concurrently in another clinical trial
10. Is receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition, chronic use of anticoagulants, or taking corticosteroids,
11. Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee,
12. Active joint infection or history of chronic joint infection at the surgical site,
13. Prior total meniscectomy of either knee,
14. Has severe patellofemoral malalignment/maltracking or patellar instability
15. Radiographically has >5 degrees of malalignment
16. Has received, within the past 3 months HA or cortisone injections in knee,
17. Has undergone prior tendon repair, meniscus repair, ligament repair or distal realignment/osteotomy surgery in the index knee, < 6 months prior to surgery,
18. Failed marrow stimulation or ACI treatment performed < 12-mo before baseline,
19. Index knee has been surgically treated for cartilage repair with OATs, mosaicplasty or osteochondral allograft,
20. Involves concomitant procedures in the affected knee with the exception of incidental loose body removal, debridement, synovectomy, retinacular release, and/or partial meniscectomy
21. Has contraindications for Magnetic Resonance Imaging (MRI),
22. Has an allergy to Polymyxin B sulfate or Bacitracin antibiotics,
23. Is receiving workman's compensation or currently involved in litigation relating to the index knee

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DeNovo NT Graft; DeNovo NT Graft stratified by lesion location - femur or patella	Other: Particulated Juvenile Articular Cartilage; Treatment of articular cartilage defects up to 7.5 cm2; Other Names: DeNovo NT Natural Tissue Graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in KOOS scores	Improvement in Knee Injury and Osteoarthritis Outcomes Survey (KOOS) scores	Between baseline and 24 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
X-ray Evaluation	X-ray evaluation of joint narrowing, and osteophyte and cyst formation	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	Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score	Preop, 12 Months and 24 Months post surgery
Incidence of adverse events		Annually to 5 years post surgery

Collaborators and Investigators

• Sponsor: Zimmer Orthobiologics, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 8, 2012
• First Submitted That Met QC Criteria: August 17, 2012
• First Posted (Estimate): August 22, 2012

Study Record Updates

• Last Update Posted (Estimate): January 26, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries
• Other Study ID Numbers: CSU2011-03B