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

NCT01471236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-03-06

No results posted yet for this study

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.

Conditions

  • Cartilage Diseases
  • Osteochondritis 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.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Elizaveta Kon, MD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2018-11-19
Completion
2018-11-19

Countries

  • Croatia
  • Czechia
  • Hungary
  • Italy
  • Poland
  • Romania
  • Serbia
  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01471236 on ClinicalTrials.gov