Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant

NCT ID: NCT03755388

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-20
• Study Completion Date: 2034-12-31

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).

Detailed Description

Lesions in the cartilage are common disorders. In the knee, cartilage lesions are found in over 50 % of all arthroscopies, where 25 % of these are of focal character and the majority are found in the medial femoral condyle. The quality of life of patients with focal cartilage defects is significantly affected and it has been shown that the quality of life is affected to the same extend as in patients scheduled for knee replacement. Arthroscopy lavage and debridement micro fracturing, mosaic plasticity as well as osteochondral autograft transplantation (OATS) are methods used for treatment of the lesions. Some have shown to help the patients but there is an ongoing treatment gap especially for patients with knee lesions and early osteoarthritis.

Episurf Medical has developed a Focal Knee Resurfacing (FKR) implant, the Episealer® implant. The implant is used for treatment of focal cartilage lesions of the lateral or medial femoral condyle in order to alleviate pain and improve range of motion. The implant and surgical instruments are customized to each patient's joint anatomy, position, and size of injury, based on patient-specific images (MRI). The Episealer® device is CE marked.

The Episealer® implant consists of a peg and a hat. The implant exists in five different diameters (12,14,17, 20 and 25mm), depending on the lesion size. The shape of the hat is circular or oval.

The Episealer® implant is made of biocompatible cobalt/chromium/molybdenum alloy. To enhance the osseointegration, the implant is coated with biocompatible hydroxyapatite onto an interlaying biocompatible pure titanium coating.

A previous study (S57685) showed that Episealer is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing). This device is a good solution when there are no alternative treatments, except prosthesis surgery, available.

The goal is to evaluate the efficacy, safety and performance of the Episealer® device in a larger sample size and on the long term.

Conditions

Cartilage Damage; Knee Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Episealer group

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

Group Type: EXPERIMENTAL

Episealer

Intervention Type: DEVICE

Placing Episealer device

Interventions

Episealer

Placing Episealer device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hilde Vandenneucker, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Lore Hermans, MSc

Role: CONTACT

orthopedie.research@uzleuven.be

+32 16338818

Kristel Van de loock, MSc

Role: CONTACT

orthopedie.research@uzleuven.be

+32 16341266

Facility Contacts

Lore Hermans, MSc

Role: primary

orthopedie.research@uzleuven.be

+32 16 33 88 18

Other Identifiers

S61896

Identifier Type: -

Identifier Source: org_study_id