Degenerative Lesion of Articular Cartilage of KneeNCT01329445
DeNovo NT Longitudinal Data Collection (LDC) Knee Study
An observational study of Degenerative Lesion of Articular Cartilage of Knee and Osteochondritis Dissecans, run by Zimmer Orthobiologics, Inc. at 15 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Lesion of Articular Cartilage of Knee, Osteochondritis Dissecans
- What is being tested?
- DeNovo NT, Natural Tissue Graft
- How many people
- 160 participants
- Where
- 15 sitesUnited States
- Study dates
- Feb 2011to Dec 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being recommended for arthroscopic or surgical intervention for articular cartilage lesionis of the knee
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
New Mexico Orthopaedic Associates
Albuquerque, New Mexico, 87106
Emory University
Atlanta, Georgia, 30329
Colorado Orthopedic Consultants
Aurora, Colorado, 80012
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
University of Virginia
Charlottesville, Virginia, 22903
Midwest Orthopaedics at Rush Univ Hospital
Chicago, Illinois, 60612
Specialized Orthopaedics & Sports Medicine
Columbus, Ohio, 43215
Cleveland Clinic Sports Health Center
Garfield Heights, Ohio, 44125
Aurora Baycare Medical Center
Green Bay, Wisconsin, 54308
OrthoIndy
Greenwood, Indiana, 46143
Specialized Orthopaedic Surgery & Spine Center
Huntsville, Alabama, 35802
Dean Clinic
Madison, Wisconsin, 53715
Naval Medical Center San Diego
San Diego, California, 92134
Jordan Young Institute
Virginia Beach, Virginia, 23462
About this study
Official title: Post Market, Longitudinal Data Collection Study of DeNovo NT for Articular Cartilage Defects of the Knee
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.
Read the detailed 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.
- Being tested
- DeNovo NT, Natural Tissue Graft
- Keywords
- Cartilage repair, Articular cartilage defects
- Medical subject headings
- Osteochondritis Dissecans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeNovo NT, Natural Tissue GraftOther
Also called DeNovo NT
DeNovo NT Natural Tissue Graft of 1 or 2 lesions up to 5 cm squared in area.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: DeNovo NT, Natural Tissue Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean scores from patient-reported clinical outcome surveys
Measured: 5 years
Secondary outcomes (1)
Incidence of reoperations and revision surgeries
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lesion of Articular Cartilage of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Orthobiologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329445
- Sponsor's protocol ID
- CSU2010-22B
- Status last verified
- Dec 2016
- First submitted
- 1 Apr 2011
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market, Longitudinal Data Collection Study of DeNovo NT for Articular Cartilage Defects of the Knee
- ClinicalTrials.gov ID
- NCT01329445
- Acronym / sponsor ID
- CSU2010-22B
- Keywords
- Cartilage repair, Articular cartilage defects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Zimmer Orthobiologics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DeNovo NT patient | – | Other: DeNovo NT, Natural Tissue GraftPatients who have received or who are scheduled to receive a DeNovo NT graft for repair of 1-2 knee cartilage lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being recommended for arthroscopic or surgical intervention for articular cartilage lesionis of the knee
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeNovo NT, Natural Tissue GraftAlso: DeNovo NTDeNovo NT Natural Tissue Graft of 1 or 2 lesions up to 5 cm squared in area. | Other | DeNovo NT patient |
Primary outcome
Mean scores from patient-reported clinical outcome surveys
Time frame: 5 years
1 secondary outcome
Incidence of reoperations and revision surgeries
Time frame: 5 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Lesion of Articular Cartilage of Knee and Osteochondritis Dissecans, run by Zimmer Orthobiologics, Inc. at 15 sites in United States.
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 5 inclusion and 5 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 15 sites in United States. 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?
Mean scores from patient-reported clinical outcome surveys (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.