An interventional study of Microfracture and Cartilage Autograft Implantation System in Defect of Articular Cartilage and Osteochondritis Dissecans, sponsored by DePuy Mitek. Terminated at 29 sites in 2 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-08-03.
Sponsored by DePuy Mitek (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
Among 13 studies in Osteochondritis Dissecans with a site in United States — 4 open to participants now, 4 under way, 1 of them phase 3. Osteochondritis Dissecans · United States.
Among the 13 studies in Osteochondritis Dissecans with a site in United States, this one is the only one that started in 2010, is one of 6 with no phase, and was the 1st registered.
30 studies on the registry are indexed under Osteochondritis Dissecans; 7 are open to participants now.
Browse Osteochondritis Dissecans studies →4 of the 13 studies in Osteochondritis Dissecans with a site in United States are open now. Recruiting first, the newest first:
Fin-Ceramica Faenza Spa · Sites in United States, Italy
Ages 18–60
Vericel Corporation · Sites in United States
Ages 10–17
University of Pennsylvania · Sites in United States
Duke University · Sites in United States
Ages 18–85
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 6 Osteochondritis Dissecans studies recruiting now, 2 set no upper age limit and 4 stop at 75 or younger; 5 take children under 18; none take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · no healthy volunteers.
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13 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 1 started in 2010.
This study's enrollment of 75 is above the median of 45 across 17 interventional studies indexed under Osteochondritis Dissecans.
Median enrollment 75 across the 7 interventional studies, 130 across the 6 observational. Of the 6 that completed or were terminated, 1 (17%) have results posted.
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6 of 13 have an industry lead sponsor. The 10 most frequent:
DePuy Mitek is the lead sponsor of 3 studies on the registry; none are open to participants now.
Johnson & Johnson has 2 studies filed under Osteochondritis Dissecans — fewer than ten, so there is no comparison to draw.
1 of the studies in Osteochondritis Dissecans with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02664337Duke UniversityConjoint Analysis of Patient Preferences in Joint Interventions | 2027-07 |
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Among the 13 studies in Osteochondritis Dissecans with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The Cartilage Autograft Implantation System (CAIS) is designed as a single surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region. CAIS is indicated for the repair of articular cartilage lesions and osteochondritis dissecans (OCD) of the knee through cartilage regeneration.
The Cartilage Autograft Implantation System (CAIS) is a kit of devices that utilizes morselized autologous hyaline cartilage harvested arthroscopically, affixed onto a synthetic, resorbable implant using a fibrin sealant and implanted in a single surgical procedure. The system is designed as a surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region.
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Exclusion Criteria:
Randomized to Microfracture
Procedure: Microfracture
Randomized to Device
Device: Cartilage Autograft Implantation System
Non-randomized with lesion greater than 6cmˆ2
Device: Cartilage Autograft Implantation System
The microfracture procedure is a standard method for treatment of cartilage damage in which the surgeon will clean the site of your cartilage damage and then will make several small holes in your bone to stimulate your bone marrow with the intention to repair the damaged area with new cartilage tissue
A surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region
To determine the safety and efficacy of CAIS compared to microfracture at 24 months post-treatment, with the primary efficacy assessment based on an analysis of superiority of CAIS to microfracture for reduction in knee pain and improvement in function
Time frame: 24 Months
To determine the safety of CAIS through 48 months
Time frame: 48 Months
Plan to share: No — These data will not be used in support of an FDA submission, and the product will not be commercialized. As such, there is no plan to share the IPD.
No publications or documents are linked to this record.
The record gives a start of Jul 2010, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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