Evaluation of the Agili-C Biphasic Implant in the Knee Joint

NACompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

November 19, 2018

Study Completion Date

November 19, 2018

Conditions
Cartilage DiseasesOsteochondritis Dissecans
Interventions
DEVICE

Agili-C Bi-phasic Implant

"The implantation site should be created in perpendicular manner to the articular cartilage. The surrounding tissue will be cleaned and scraped to prepare a clean site. The implant will be placed in the correct orientation (drilled channels pointing towards the joint side and chamfer towards the bone).~The implant will be inserted gently in a pressed fit manner."

PROCEDURE

mini-arthrotomy

"The procedure will be conducted according to hospital practice. The implants will be positioned via open incision, depending on lesion location, and Investigator's final decision. Related treatments during the procedure should be recorded.~Device positioning details medications and adverse events during the procedure will be recorded. MOCART (off-site), X-ray evaluation (off-site), ICRS Cartilage injury mapping system, Articular cartilage injury Classification and the Osteochondritis Dissecans classification will be recorded."

Trial Locations (9)

Unknown

Clinical Hospital ''Sveti Duh'', Zagreb

Fakultní nemocnice Brno, Brno

Uzsoki Street Hospital, Budapest

Rizzoli Orthopaedic Institute, Bologna

Avimed Hospital, Katowice

County Hospital of Timisoara,, Timișoara

"Institut Za Ortopediju Banjica", Belgrade

Clinical center of Vojvodina, Novi Sad

University Medical Centre, Ljubljana, Ljubljana

All Listed Sponsors
lead

Smith & Nephew, Inc.

INDUSTRY

NCT01471236 - Evaluation of the Agili-C Biphasic Implant in the Knee Joint | Biotech Hunter | Biotech Hunter