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

  • STATUS
    Recruiting
  • End date
    Dec 29, 2022
  • participants needed
    8
  • sponsor
    Universitaire Ziekenhuizen Leuven
Updated on 29 March 2021

Summary

Lesions in the cartilage are common disorders. 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.

In this study, the investigators aims to establish if this implant is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing)

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).

In this study, the investigators aims to establish if this implant is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing).

Details
Condition Focal Cartilage Lesions
Treatment Follow-up of Episealer implant
Clinical Study IdentifierNCT04808700
SponsorUniversitaire Ziekenhuizen Leuven
Last Modified on29 March 2021

Eligibility

Yes No Not Sure

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 of 18 years old (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. The maximum size of the lesion is set at 6cm
Informed consent obtained

Exclusion Criteria

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)
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