Clinical trial NCT01400607: Neocartilage Implant to Treat Cartilage Lesions of the Knee
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Articular Cartilage Disorder
Degeneration; Articular Cartilage
Chronic Cartilage Injury
Acute Cartilage Injury
Defect of Articular Cartilage
Keywords: cartilage
knee surgery
cartilage injury
knee pain
cartilage repair
cartilage damage
cartilage lesion
cartilage defect
articular cartilage lesion
articular cartilage defect
juvenile
cells
ISTO Technologies
Neocartilage
RevaFlex
Lead sponsor: ISTO Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 lesions of the knee compared to microfracture treatment.

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 osteoarthritis. The lack of effective cartilage repair approaches or products for restoration of defective articular cartilage to its native, hyaline morphology only continues to exacerbate the incidence of osteoarthritis as these initial defects enlarge and degrade over a 10 to 20 year period. The repair of cartilage, especially in the knee, remains a formidable clinical challenge. Regenerative medicine approaches to cartilage repair have only begun to be explored as possible options and there is a clear trend toward biological solutions for the repair and regeneration of damaged or diseased articular cartilage. The study was designed to compare how well the Neocartilage Implant works against the microfracture therapy, a widely used and accepted cartilage repair therapy. Data to be collected include Pain and Function in Daily Living scores, symptoms, Function in Sports and Recreation, and Knee Related Quality of Life. Additionally, MRI and X-rays will be collected to evaluate the cartilage repair progress. These assessments will be used through the five years of post-operative follow-up.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcomes Scores (KOOS)
timeFrame: 36 months
Secondary outcomes:
measure: IKDC Knee Examination
timeFrame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years
measure: Subject reported questionnaires
timeFrame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kerlan Jobe Orthopaedic Clinic
state: California
city: Santa Monica
country: United States
facility: Santa Monica Orthopaedic & Sports Medicine Group
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: New York
country: United States
facility: Hospital for Special Surgery -Sports Medicine and Shoulder Service
state: New York
city: New York
country: United States
facility: Insall Scott Kelly Institute for Orthopaedics & Sports Medicine
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Sports Medicine Center
state: Ohio
city: Greenville
country: United States
facility: The Hawkins Foundation
state: South Carolina
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
Study officials:
affiliation: ISTO Technologies, Inc.
name: Michaela Purcell
role: STUDY_DIRECTOR
References: