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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long-term Prospective Interventional Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant

Conditions
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Cartilage Damage, Knee Injuries

Intervention / Treatment
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* Device: Episealer


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Episealer group<br>Subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible | Device: Episealer<br>* Placing Episealer device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic measurements | Efficacy will be evaluated with the comparison of the pre- and post- operative radiographs | 10 years | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) | Performance will be evaluated with the comparison of the pre- and post- operative KOOS-scores. Scoring: each item is scored between 0 and 4 and the raw score of each section is the sum or item scores. The score is then converted into a 0-100 scale. A higher score indicates fewer problems | 10 years | 
| Visual Analogue Scale (VAS) pain | Performance will be evaluated with the comparison of the pre- and post- operative VAS-scores. Score between 0 and 10. Higher score indicates more pain. | 10 years | 
| Complications | Safety will be evaluated by monitoring AEs, unanticipated device effects and subsequent interventions through 10 years post treatment | 10 years |