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

Not Applicable

Completed

• Conditions: Cartilage Diseases; Osteochondritis Dissecans
• Interventions: Device: Agili-C Bi-phasic Implant; Procedure: mini-arthrotomy

• Registration Number: NCT01471236
• Lead Sponsor: Smith & Nephew, Inc.

Brief Summary

The purpose of this study is to determine the performance of the Agili-C implants. The study hypothesis is that Agili-C implants are effective in the treatment of focal cartilage and cartilage-bone joint surface defects.

Detailed Description

Agili-C implant is a bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of focal articular cartilage and for osteochondral defects. Up to 50 patients are to be included in the study. Patients suffering from isolated, single and focal cartilage or osteochondral defect at the knee joint are considered for study inclusion.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-11-10
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-15
• Primary Completion: 2018-11-19
• Study Completion: 2018-11-19
• Status Verified: 2020-02
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Agili-c bi-phasic implant	Agili-C Bi-phasic Implant	mini-arthrotomy
Agili-c bi-phasic implant	mini-arthrotomy	mini-arthrotomy

Primary Outcome Measures

Name	Time	Method
improvement in KOOS pain subscales	24 months	The primary efficacy endpoint for this trial will be the change from baseline up to 24 months visit in pain score as measured by the KOOS pain subscale

Secondary Outcome Measures

Name	Time	Method
KOOS total score	24 months	* Change from baseline to 3, 6, 9, 12, 18 and 24 months visits as measured by the KOOS total score and subscales.; * Change from baseline to 18 and 24 months visit in IKDC current health assessment.; * Change from baseline to 3, 6, 12, 18 and 24 months visit in Lysholm with Tegner knee score.; * Change from baseline to 3, 6, 12 , 18 and 24 months visit in IKDC knee examination form 2000; * Change from baseline to 3, 6, 12 , 18 and 24 months visit in IKDC subjective knee evaluation; * Change in MOCART scoring as measured at 3, 6, 12 , 18 and 24 months visit

Trial Locations

Locations (9)

Clinical Hospital ''Sveti Duh''; 🇭🇷 Zagreb, Croatia

County Hospital of Timisoara,; 🇷🇴 Timisoara, Romania

Clinical center of Vojvodina; 🇷🇸 Novi Sad, Serbia

Institut Za Ortopediju "Banjica"; 🇷🇸 Belgrade, Serbia

University Medical Centre, Ljubljana; 🇸🇮 Ljubljana, Slovenia

Fakultní nemocnice Brno; 🇨🇿 Brno, Czechia

Uzsoki Street Hospital; 🇭🇺 Budapest, Hungary

Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, Italy

Avimed Hospital; 🇵🇱 Katowice, Poland