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Agili-C™ Implant Performance Evaluation

NCT03299959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2025-12-05

Study results available
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Summary

The current study compares the efficacy and safety of the Agili-C implant to Surgical Standard of Care treatment in patients suffering from joint surface lesions of the knee. The patient population is heterogeneous, involving different kinds of joint surface lesions: focal cartilage lesions, osteochondral defects and mild to moderate osteoarthritis, including multiple defects.

Conditions

  • Cartilage or Osteochondral Defects in the Knee
  • Up to Moderate Osteoarthritis

Interventions

DEVICE

Agili-C implant

Agili-C implant

PROCEDURE

SSOC

microfracture and/or debridement

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Elizaveta Kon, MD · Istituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-25
Primary Completion
2024-11-14
Completion
2024-11-14
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Hungary
  • Israel
  • Italy
  • Poland
  • Romania
  • Serbia

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 NCT03299959 on ClinicalTrials.gov