Articular Cartilage Disorder
Conditions
Brief summary
The purpose is to assess the safety profile and performance of a femoral resurfacing implant for localized chondral lesions.
Detailed description
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.
Interventions
DEVICEImplant surgery
surgery
Sponsors
Episurf Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female 2. Age 30 ≤ 65 years 3. 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 4. Cartilage lesion area \< 3.2 cm2 (diameter \< 2 cm) 5. Failed earlier conservative or surgical interventions such as lavage, abrasions, drilling or microfracture 6. VAS-pain symptom \>40 for more than 6 months 7. 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) 8. Capable of completing self-administered questionnaires 9. Willing to comply with the follow-up requirements of the study 10. Signed informed consent
Exclusion criteria
1. BMI ≥ 35 kg/m2 (severe obesity) 2. Instability or deficiency of soft tissues, vascular or muscular insufficiency 3. Metabolic disorders which may impair bone formation 4. Diabetes mellitus 5. Smokers 6. 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) 7. Irresolvable joint pain or loss-of-function with an undeterminable cause 8. Diagnosis of a concomitant meniscal injury in involved knee that requires surgical intervention 9. Loss of joint space on standing radiographs (≥ 1 on Ahlbäck-scale (0-5)) 10. Avascular necrosis 11. Infections, systemic or local 12. Known metal allergies 13. History of inflammatory arthritis 14. Pregnancy 15. Pacemaker implant 16. History of drug or substance abuse 17. Systemic administration within 30 days prior to the study of any type of corticosteroid, antineoplastics, immune stimulating or immunosuppressive agents 18. Participation in another clinical trial using an investigational new drug or device within 30 days of entrance into this study. 19. Condition that may have an impact on the outcome of the investigation as judged by the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events | 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance | 24 months | Clinical performance, by questionnaires and knee ROM measurements. |
Countries
Sweden
Outcome results
None listed