Neocartilage Implant to Treat Cartilage Lesions of the Knee
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| ClinicalTrials.gov Identifier: NCT01400607 |
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Recruitment Status :
Terminated
(Poor enrollment)
First Posted : July 22, 2011
Last Update Posted : August 31, 2017
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Sponsor:
ISTO Technologies, Inc.
Information provided by (Responsible Party):
ISTO Technologies, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Articular Cartilage Disorder Degeneration; Articular Cartilage Chronic Cartilage Injury Acute Cartilage Injury Defect of Articular Cartilage | Biological: Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft) Other: Microfracture | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 14 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 Start Date : | July 2011 |
| Estimated Primary Completion Date : | September 2020 |
| Estimated Study Completion Date : | September 2020 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Neocartilage Implant
Neocartilage Implant surgically implanted and affixed to subchondral bone using commercial fibrin during mini-open knee arthrotomy.
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Biological: Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)
The Neocartilage Implant is a cartilage repair technology cultured from juvenile human cartilage cells.
Other Name: RevaFlex |
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Microfracture
Standard of care cartilage repair technique.
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Other: Microfracture
Marrow stimulation using the microfracture technique; performed arthroscopically
Other Name: marrow stimulation |
Primary Outcome Measures :
- Knee Injury and Osteoarthritis Outcomes Scores (KOOS) [ Time Frame: 36 months ]Knee Injury and Osteoarthritis Outcomes Scores (KOOS) Pain and Function in Daily Living (ADL) subscales.
Secondary Outcome Measures :
- IKDC Knee Examination [ Time Frame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years ]
- Subject reported questionnaires [ Time Frame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years ]Various questionnaires are required to be completed by the subject before and after treatment throughout the study.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400607
Locations
| United States, California | |
| Kerlan Jobe Orthopaedic Clinic | |
| Los Angeles, California, United States, 90045 | |
| Santa Monica Orthopaedic & Sports Medicine Group | |
| Santa Monica, California, United States, 90404 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, New York | |
| Hospital for Special Surgery -Sports Medicine and Shoulder Service | |
| New York, New York, United States, 10021 | |
| Insall Scott Kelly Institute for Orthopaedics & Sports Medicine | |
| New York, New York, United States, 10065 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| The Ohio State University Sports Medicine Center | |
| Columbus, Ohio, United States, 43221 | |
| United States, South Carolina | |
| The Hawkins Foundation | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Texas | |
| The Methodist Hospital Research Institute | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
ISTO Technologies, Inc.
Investigators
| Study Director: | Michaela Purcell | ISTO Technologies, Inc. |
| Responsible Party: | ISTO Technologies, Inc. |
| ClinicalTrials.gov Identifier: | NCT01400607 History of Changes |
| Other Study ID Numbers: |
ISTO NEO-01-09-01 |
| First Posted: | July 22, 2011 Key Record Dates |
| Last Update Posted: | August 31, 2017 |
| Last Verified: | September 2016 |
Keywords provided by ISTO Technologies, Inc.:
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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 |
Additional relevant MeSH terms:
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Wounds and Injuries Cartilage Diseases Musculoskeletal Diseases Connective Tissue Diseases |