NCT03755388

Brief Summary

The goal of this study is to evaluate the efficacy, safety and performance of the Episealer® device in a sample size of 30 patients and on the long term (10 years follow-up).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
104mo left

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Sep 2018Dec 2034

Study Start

First participant enrolled

September 20, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
16 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2034

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

16.2 years

First QC Date

November 5, 2018

Last Update Submit

March 6, 2026

Conditions

Cartilage DamageKnee Injuries

Outcome Measures

Primary Outcomes (1)

  • Survival

    Presence of the implant in the patient up to 10 years post treatment with loss/revision of the primary implant as endpoint

    10 years

Secondary Outcomes (4)

  • Radiographic measurements

    10 years

  • Knee injury and Osteoarthritis Outcome Score (KOOS)

    10 years

  • Visual Analogue Scale (VAS) pain

    10 years

  • Complications

    10 years

Study Arms (1)

Episealer group

EXPERIMENTAL

Subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible

Device: Episealer

Interventions

EpisealerDEVICE

Placing Episealer device

Episealer group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible
  • Minimal age 18 years (Preferred age group \>40 years)
  • Suitable for implant, to be determined by analysis of MRI imaging. Suitability is set by the size and location of the lesion.
  • Informed consent

You may not qualify if:

  • Under age (\<18yrs)
  • Active or recent (\<1 yr) septic arthritis of the involved knee
  • Associated symptomatic untreated ligamentary or meniscal pathology in the involved knee
  • (Severe) osteoarthritis in the involved or other compartments of the involved knee
  • Severe osteoporosis
  • MRI not possible (eg. due to pacemaker)
  • Marked valgus- or varus alignment (\>6 degrees)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Hilde Vandenneucker, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 28, 2018

Study Start

September 20, 2018

Primary Completion (Estimated)

December 1, 2034

Study Completion (Estimated)

December 1, 2034

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)