Investigation of a Customized Femoral Resurfacing Implant

Study Overview
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Brief Summary
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The purpose is to assess the safety profile and performance of a femoral resurfacing implant for localized chondral lesions.

Detailed Description
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The implant's safety profile will be assessed by incidence of any subject having any of the seven identified implant-related clinical undesirable side effects. This will be analyzed with a one-side exact binomial test on significance level 0.05, at 24 months post-operatively.

Official Title
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Investigation of a Customized Femoral Resurfacing Implant (Episealer® Knee Condyle Device) to Assess the Safety Profile and Performance for 2 Years Post-operatively

Conditions
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Articular Cartilage Disorder

Intervention / Treatment
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* Device: Implant surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Age 30 ≤ 65 years Chondral defects of the femoral cartilage ICRS grade 3 (severely abnormal cartilage defects > 50% of the cartilage depth) or grade 4 (severely abnormal, through the cartilage depth) on medial or lateral femoral condyles Cartilage lesion area < 3.2 cm2 (diameter < 2 cm) Failed earlier conservative or surgical interventions such as lavage, abrasions, drilling or microfracture VAS-pain symptom >40 for more than 6 months The arthroscopic finding corresponds to the expected; size of cartilage lesion is correct and no other significant pathology (see CIP, Intra-operative check-list, Appendix I) Capable of completing self-administered questionnaires Willing to comply with the follow-up requirements of the study Signed informed consent Exclusion Criteria: BMI ≥ 35 kg/m2 (severe obesity) Instability or deficiency of soft tissues, vascular or muscular insufficiency Metabolic disorders which may impair bone formation Diabetes mellitus Smokers Diagnosis of a concomitant knee injury which the Investigator appreciates may interfere with study participation (i.e. may confound efficacy assessment or healing at the involved knee joint level) Irresolvable joint pain or loss-of-function with an undeterminable cause Diagnosis of a concomitant meniscal injury in involved knee that requires surgical intervention Loss of joint space on standing radiographs (≥ 1 on Ahlbäck-scale (0-5)) Avascular necrosis Infections, systemic or local Known metal allergies History of inflammatory arthritis Pregnancy Pacemaker implant History of drug or substance abuse Systemic administration within 30 days prior to the study of any type of corticosteroid, antineoplastics, immune stimulating or immunosuppressive agents Participation in another clinical trial using an investigational new drug or device within 30 days of entrance into this study. Condition that may have an impact on the outcome of the investigation as judged by the Investigator.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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: Surgery<br>Implant surgery | Device: Implant surgery<br>* surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events | The primary efficacy analysis in this study is to ascertain that the incidence of at least one subject having any of the seven identified clinical undesirable side effects is lower than 38 % (risk profile of the comparator) up to the 24 months analysis in the PP population. This will be analyzed with a one-side exact binomial test on significance level 0.05 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance | Clinical performance, by questionnaires and knee ROM measurements. | 24 months |