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Defect of Articular CartilageNCT01670617

DeNovo NT Natural Tissue Graft Stratified Knee Study

A study testing Particulated Juvenile Articular Cartilage in people with Defect of Articular Cartilage and Knee Injuries, run by Zimmer Orthobiologics, Inc. at 18 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Defect of Articular Cartilage, Knee Injuries
What is being tested?
Particulated Juvenile Articular Cartilage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
18 sitesin 2 countries
Study dates
Mar 2012to Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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,
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  • 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

Who cannot join

  • 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,
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  • 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
  • Is pregnant or breast-feeding,
  • Body Mass Index >35 (BMI=kg/m2),
  • Is participating concurrently in another clinical trial
  • 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,
  • Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee,
  • Active joint infection or history of chronic joint infection at the surgical site,
  • Prior total meniscectomy of either knee,
  • Has severe patellofemoral malalignment/maltracking or patellar instability
  • Radiographically has >5 degrees of malalignment
  • Has received, within the past 3 months HA or cortisone injections in knee,
  • Has undergone prior tendon repair, meniscus repair, ligament repair or distal realignment/osteotomy surgery in the index knee, < 6 months prior to surgery,
  • Failed marrow stimulation or ACI treatment performed < 12-mo before baseline,
  • Index knee has been surgically treated for cartilage repair with OATs, mosaicplasty or osteochondral allograft,
  • Involves concomitant procedures in the affected knee with the exception of incidental loose body removal, debridement, synovectomy, retinacular release, and/or partial meniscectomy
  • Has contraindications for Magnetic Resonance Imaging (MRI),
  • Has an allergy to Polymyxin B sulfate or Bacitracin antibiotics,
  • Is receiving workman's compensation or currently involved in litigation relating to the index knee

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

United States16 sites

  • New Mexico Orthopaedic Consultants

    Albuquerque, New Mexico, 87106

  • Emory Spine & Sports Medicine Center

    Atlanta, Georgia, 30329

  • Colorado Orthopedic Consultants

    Aurora, Colorado, 80012

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • TRIA Orthopaedic Center

    Bloomington, Minnesota, 55431

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics

    Edina, Minnesota, 55435

  • Andrews Institute for Orthopaedics & Sports Medicine

    Gulf Breeze, Florida, 32561

  • A.T. Still University of Health Sciences

    Kirksville, Missouri, 63501

  • Kerlan Jobe Orthopaedics

    Los Angeles, California, 90045

  • Tulane University Medical Center

    New Orleans, Louisiana

  • Oregon Health & Science University

    Portland, Oregon, 97201

  • San Antonio Military Medical Center

    San Antonio, Texas, 78234

  • Naval Medical Center San Deigo

    San Deigo, California, 92134

  • University Orthopaedic Associates

    Somerset, New Jersey, 08873

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

Other trials in United States

Canada2 sites

  • Ottawa Hospital

    Ottawa, Ontario

  • Women's College Hospital

    Toronoto, M5S 1B1

Other trials in Canada

About this study

Official title: 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.

Being tested
Particulated Juvenile Articular Cartilage
Medical subject headings
Knee Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Particulated Juvenile Articular CartilageOther

    Also called DeNovo NT Natural Tissue Graft

    Treatment of articular cartilage defects up to 7.5 cm2

Study groups in NCT01670617
Study groupRoleWhat they receive
DeNovo NT GraftOtherDeNovo NT Graft stratified by lesion location - femur or patella
Receives: Other: Particulated Juvenile Articular Cartilage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in KOOS scores

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

    Measured: Between baseline and 24 months post surgery

Secondary outcomes (5)

  1. X-ray Evaluation

    X-ray evaluation of joint narrowing, and osteophyte and cyst formation

    Measured: Preop, 12 months and 24 months post surgery

  2. Incidence and time to reoperation/revision

    Measured: 5 years

  3. Mean IKDC Knee Examination grades

    Measured: Annually to 5 years post surgery

  4. MRI Evaluation

    Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score

    Measured: Preop, 12 Months and 24 Months post surgery

  5. Incidence of adverse events

    Measured: Annually to 5 years post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01670617
Sponsor's protocol ID
CSU2011-03B
Status last verified
Dec 2016
First submitted
8 Aug 2012
Last updated
26 Jan 2017
Results posted
No
Data monitoring committee
No

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.

    PubMed 22624244

Questions about this trial

What is this clinical trial studying?

A study testing Particulated Juvenile Articular Cartilage in people with Defect of Articular Cartilage and Knee Injuries, run by Zimmer Orthobiologics, Inc. at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in KOOS scores (time frame: Between baseline and 24 months post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01670617, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.

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