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Episealer® Knee System IDE Clinical Study

NCT04000659 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-07-30

No results posted yet for this study

Summary

The study is a randomized, prospective, multicenter, controlled clinical trial of the Episealer Knee System. The Episealer Knee System is intended for subjects with up to two focal femoral knee chondral or osteochondral lesion that is causing pain and/or disability and requires surgical treatment.

Conditions

  • Degenerative Lesion of Articular Cartilage of Knee

Interventions

DEVICE

Episealer Knee System

The Episealer Knee System is comprised of individualized endoprosthetic resurfacing implants and implantation tools (Episealer Toolkit). The implants are designed to replace the articulating surface which has been damaged due to femoral knee chondral and osteochondral defects.

PROCEDURE

Microfracture

Microfracture is a minimally invasive surgical technique developed to repair defects in articular cartilage and reduce pain in the knee joint. Microfracture techniques are described in the orthopedic literature and are performed arthroscopically.

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Episurf Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Katarina Flodström · Episurf Medical Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2026-06-30
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States
  • Canada
  • Germany
  • United Kingdom

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 NCT04000659 on ClinicalTrials.gov