Cartilage RepairNCT00791245
Post Market Study of DeNovo NT, Natural Tissue Graft
An observational study of Cartilage Repair, run by Zimmer Orthobiologics, Inc. at 3 sites in United States.
Trial summary
The purpose of this post market study is to evaluate surgical implantation technique and the quality of repair of the cartilage defect with particulated juvenile cartilage in the human knee joint. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cartilage Repair
- What is being tested?
- Particulated Juvenile Cartilage Allograft
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2006to Aug 2012
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Clinical population
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, or
- Practicing abstinence, or
- Surgically sterilized, or
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- Postmenopausal
- Pretreatment arthroscopic confirmation indicating one or two contained lesion(s) are equal to an ICRS Grade 3a, 3b, 3c, 3d of the femoral condyle or trochlear groove and OCD lesions (Grade 4a) with healed bone base, which is non sclerotic and no loss of bone greater than 6mm measured from the surrounding subchondral plate,
- Has peripheral cartilage debridement to healthy cartilage that results in a lesion(s) with an area of greater than or equal to 1 cm squared and less than or equal to 5 cm squared,
- PCL, LCL and MCL in the affected knee are stable and the ACL is stable or can be stabilized as a concomitant procedure,
- Ipsilateral knee compartment has intact menisci (or requires partial meniscectomy resulting in stable menisci),
- The contralateral knee is asymptomatic, stable and fully functional,
- Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits through 24 months.
Who cannot join
- Clinical and/or radiographic 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,
- Osteochondritis dissecans of the knee with significant bone loss (greater than 6mm deep from the subchondral plate),
- Associated damage to the underlying subchondral bone requiring an osteochondral graft,
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- 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 including subjects on immunosuppressant therapies, or has significant illness (metastasis of any type) that decreases the probability of survival to the 2 year endpoint,
- Is at substantial risk for the need of organ transplantation, such as renal insufficiency,
- Is pregnant or breast-feeding,
- Body Mass Index >35 (BMI=kg/m2),
- Has bipolar articular cartilage involvement or kissing lesions of the ipsilateral compartment, described as tibial or patellar lesions in the same compartment with greater than ICRS Grade 2 chondrosis,
- Is participating concurrently in another clinical trial, or has participated ina clinical trial within 30 days of surgery,
- 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,
- Prior total meniscectomy of either knee,
- Radiographically has >5 degrees of malalignment as measured from the hip, knee and ankle mechanical axis,
- Has received, within the past three months intra-articular hyaluronic acid therapy or cortisone injections in the index knee,
- Prior realignment surgery in the affected knee within the past 6 months,
- Failed microfracture treatment performed less than 12-months before baseline,
- Is receiving workman's compensation or currently involved in litigation relating to the index knee,
- Has history of alcoholism, medication or intravenous drug abuse, psychosis, is a prisoner, has a personality disorder(s), poor motivation, emotional or intellectual issues that would likely make the subject unreliable for the study, or any combination of variables in the investigator's judgement that should exclude a potential subject,
- Had or have an aneurysm clip implanted, intraocular foreign bodies (commonly seen in welders), subcutaneous metal shards (found in sheet metal workers), or some shrapnel; additionally no cardiac pacemaker, defibrillator, implanted neurostimulator (TENS implants), some prosthetic heart valve (especially mitral valve), cochlear implant or other hearing aid, or has a tendency of claustrophobia. Have tattoos that may contain iron-based dyes.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New Mexico Orthopaedic Association, PC
Albuquerque, New Mexico, 87106
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612
OrthoIndy
Indianapolis, Indiana, 46237
About this study
Official title: A Post Market Study of Articular Cartilage Defects of the Knee Treated Wtih DeNovo NT, Natural Tissue Graft
The purpose of this post market study is to evaluate surgical implantation technique and the quality of repair of the cartilage defect with particulated juvenile cartilage in the human knee joint.
Read the detailed description
The intent of this post market study is to assess the clinical outcomes of DeNovo NT, a particulated juvenile cartilage tissue for the treatment of one or two contained lesion(s) equal to an ICRS Grade 3a, 3b, 3c, 3d of the femoral condyle or trochlear groove and OCD lesions (Grade 4a) with healed bone base, which is non sclerotic and no loss of bone greater thank 6mm measured from the surrounding subchondral plate.
- Conditions
- Cartilage Repair
- Being tested
- Particulated Juvenile Cartilage Allograft
- Keywords
- ISTO Technologies, Inc, cartilage repair, arthroscopy, 361 HCT/P, human tissue, biologic, knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Particulated Juvenile Cartilage AllograftBiological
Particulated Juvenile Cartilage Allograft
| Study group | Role | What they receive |
|---|---|---|
| 1 | DeNovo NT Receives: Biological: Particulated Juvenile Cartilage Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS
Measured: Preoperatively, postoperatively at 10 Days, 3, 6, 12, 18 & 24 Months
Secondary outcomes (1)
IKDC Subjective Knee Evaluation
Measured: Preopertively, postoperatively at 10 Days, 3, 6, 12, 18, & 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startJan 2006
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage RepairStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 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
- NCT00791245
- Sponsor's protocol ID
- ISTO - DeNovo NT 03-07-02
- Status last verified
- Aug 2014
- First submitted
- 13 Nov 2008
- Last updated
- 11 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Study of Articular Cartilage Defects of the Knee Treated Wtih DeNovo NT, Natural Tissue Graft
- ClinicalTrials.gov ID
- NCT00791245
- Acronym / sponsor ID
- ISTO - DeNovo NT 03-07-02
- Conditions
- Cartilage Repair
- Keywords
- ISTO Technologies, Inc, cartilage repair, arthroscopy, 361 HCT/P, human tissue, biologic, knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Zimmer Orthobiologics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 14 Nov 2008 (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 post market study is to evaluate surgical implantation technique and the quality of repair of the cartilage defect with particulated juvenile cartilage in the human knee joint.
Detailed description
The intent of this post market study is to assess the clinical outcomes of DeNovo NT, a particulated juvenile cartilage tissue for the treatment of one or two contained lesion(s) equal to an ICRS Grade 3a, 3b, 3c, 3d of the femoral condyle or trochlear groove and OCD lesions (Grade 4a) with healed bone base, which is non sclerotic and no loss of bone greater thank 6mm measured from the surrounding subchondral plate.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Biological: Particulated Juvenile Cartilage AllograftDeNovo NT |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Clinical population
Key inclusion criteria (13 listed)
- Voluntary signature of the IRB approved Informed Consent
- Male or female subjects between the ages of 18 to 55 years
- If female:
- Pretreatment arthroscopic confirmation indicating one or two contained lesion(s) are equal to an ICRS Grade 3a, 3b, 3c, 3d of the femoral condyle or trochlear groove and OCD lesions (Grade 4a) with healed bone base, which is non sclerotic and no loss of bone greater than 6mm measured from the surrounding subchondral plate,
- Has peripheral cartilage debridement to healthy cartilage that results in a lesion(s) with an area of greater than or equal to 1 cm squared and less than or equal to 5 cm squared,
Key exclusion criteria (26 listed)
- Clinical and/or radiographic disease diagnosis of the indexed affected joint that includes:
- 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 including subjects on immunosuppressant therapies, or has significant illness (metastasis of any type) that decreases the probability of survival to the 2 year endpoint,
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 |
|---|---|---|
| Particulated Juvenile Cartilage AllograftParticulated Juvenile Cartilage Allograft | Biological | 1 |
Primary outcome
KOOS
Time frame: Preoperatively, postoperatively at 10 Days, 3, 6, 12, 18 & 24 Months
1 secondary outcome
IKDC Subjective Knee Evaluation
Time frame: Preopertively, postoperatively at 10 Days, 3, 6, 12, 18, & 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cartilage Repair, run by Zimmer Orthobiologics, Inc. at 3 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 13 inclusion and 26 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: finished, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
KOOS (time frame: Preoperatively, postoperatively at 10 Days, 3, 6, 12, 18 & 24 Months). 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 11 Aug 2014.