Investigation of a Customized Femoral Resurfacing Implant (Knee100)
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ClinicalTrials.gov Identifier: NCT01690689
Recruitment Status : Unknown
Verified February 2015 by Episurf Medical AB. Recruitment status was: Recruiting
The purpose is to assess the safety profile and performance of a femoral resurfacing implant for localized chondral lesions.
Condition or disease
Articular Cartilage Disorder
Device: Implant surgery
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.
Number of participants with Adverse Events [ Time Frame: 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 Outcome Measures :
Clinical performance [ Time Frame: 24 months ]
Clinical performance, by questionnaires and knee ROM measurements.
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Ages Eligible for Study:
30 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
BMI ≥ 35 kg/m2 (severe obesity)
Instability or deficiency of soft tissues, vascular or muscular insufficiency
Metabolic disorders which may impair bone formation
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))
Infections, systemic or local
Known metal allergies
History of inflammatory arthritis
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.