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Neocartilage Implant to Treat Cartilage Lesions of the Knee

TerminatedPhase 3NCT01400607
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Randomized Controlled Trial to Evaluate the Efficacy of a Neocartilage Implant in the Management of ICRS Grade 3 to 4 Articular Cartilage Lesions of the Knee
Conditions
  • Articular Cartilage Disorder
  • Degeneration
  • Articular Cartilage
  • Chronic Cartilage Injury
  • Acute Cartilage Injury
  • Defect of Articular Cartilage
Interventions
  • Biological: Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)
  • Other: Microfracture
Sponsor
ISTO Technologies, Inc.
Start date
2011-07
Primary completion
2020-09
Sex
All
Age range
from 18 Years to 60 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
9

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 meniscectomy of either knee * Has received, within the past three months, intra-articular hyaluronic acid therapy, or steroid therapy * Has more than two clinically relevant chondral lesion(s) on the index knee

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01400607