Neocartilage Implant to Treat Cartilage Lesions of the Knee (NCT01400607) | Clinical Trial Compass
TerminatedPhase 3
Neocartilage Implant to Treat Cartilage Lesions of the Knee
Stopped: Poor enrollment
United States14 participantsStarted 2011-07
Plain-language summary
ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4 articular cartilage lesions of the knee compared to microfracture treatment.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Generally, the following inclusion criteria must be met, however, this is not a complete list.
* Male or Female between the ages of 18 and 60
* (1) or (2) articular cartilage lesions of the distal femur ranging in no more than 5 cm2 each
* Ipsilateral knee compartment has intact menisci (or meniscectomized remnant with \> 5mm wide rim) and stable ligaments in the affected knee
* 3 months out from initiation of conservative non-surgical management (e.g.hyaluronic acid injection, activity modification) or previous minimal surgical intervention (e.g., arthroscopic lavage, debridement) or 12 months out from marrow stimulation for this condition
Exclusion Criteria:
Generally, if a potential participant meets any of the following criterions, they will not be eligible for this study. Additionally, more criteria will be evaluated to confirm eligibility as this list is not a complete list of criteria.
* Osteoarthritis
* Rheumatoid arthritis
* History of septic or reactive arthritis
* Gout or a history of gout or pseudo-gout in the affected knee
* Osteochondritis dissecans or osteochondral lesions of the knee with bone loss \> 6mm deep
* Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e., \> than ICRS Grade 2 on the opposing articular surface)
* Associated damage to the underlying subchondral bone requiring an osteochondral graft
* Is pregnant or breast-feeding
* Has a BMI \> 35 (kg/m2)
* Has prior total meniscecto…
What they're measuring
1
Knee Injury and Osteoarthritis Outcomes Scores (KOOS)