Status:
TERMINATED
Neocartilage Implant to Treat Cartilage Lesions of the Knee
Lead Sponsor:
ISTO Technologies, Inc.
Conditions:
Articular Cartilage Disorder
Degeneration; Articular Cartilage
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 le...
Detailed Description
In the United States alone, more than 500,000 cartilage lesions per year require some treatment to reduce pain, restore joint mobility, and prevent further damage caused by the progression of osteoart...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01400607
Start Date
July 1 2011
End Date
September 1 2020
Last Update
August 31 2017
Active Locations (9)
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1
Kerlan Jobe Orthopaedic Clinic
Los Angeles, California, United States, 90045
2
Santa Monica Orthopaedic & Sports Medicine Group
Santa Monica, California, United States, 90404
3
Rush University Medical Center
Chicago, Illinois, United States, 60612
4
Hospital for Special Surgery -Sports Medicine and Shoulder Service
New York, New York, United States, 10021