Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2012-03-31
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DeNovo NT Graft
DeNovo NT Graft stratified by lesion location - femur or patella
Particulated Juvenile Articular Cartilage
Treatment of articular cartilage defects up to 7.5 cm2
Interventions
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Particulated Juvenile Articular Cartilage
Treatment of articular cartilage defects up to 7.5 cm2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Zimmer Orthobiologics, Inc.
INDUSTRY
Responsible Party
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Locations
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Kerlan Jobe Orthopaedics
Los Angeles, California, United States
Naval Medical Center San Deigo
San Deigo, California, United States
Colorado Orthopedic Consultants
Aurora, Colorado, United States
Andrews Institute for Orthopaedics & Sports Medicine
Gulf Breeze, Florida, United States
Emory Spine & Sports Medicine Center
Atlanta, Georgia, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
TRIA Orthopaedic Center
Bloomington, Minnesota, United States
Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics
Edina, Minnesota, United States
A.T. Still University of Health Sciences
Kirksville, Missouri, United States
University Orthopaedic Associates
Somerset, New Jersey, United States
New Mexico Orthopaedic Consultants
Albuquerque, New Mexico, United States
Oregon Health & Science University
Portland, Oregon, United States
San Antonio Military Medical Center
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Ottawa Hospital
Ottawa, Ontario, Canada
Women's College Hospital
Toronoto, , Canada
Countries
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References
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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.
Other Identifiers
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CSU2011-03B
Identifier Type: -
Identifier Source: org_study_id
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