Multicentre SMS Study - FR

Medacta International SA260 enrolled

Overview

Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem

Study Type

OBSERVATIONAL

Enrollment

260

Conditions

Dysplasia of Hip Joint Hip Osteoarthritis Traumatic Arthritis of Hip Avascular Necrosis of Femur Head

Interventions

Total Hip ArthroplastyPROCEDURE

Total Hip Arthroplasty with SMS Femoral Stem (Medacta)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient suffering from a severely painful and/or disabling hip joint due to osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head, and requiring a total hip replacement. * Patient who will receive a Medacta SMS femoral stem. * Patient agrees to comply with the study requirements. * Patient has signed the consent form. * Patient is affiliated with a social security system. * Patient aged 18 to 75 years Exclusion Criteria: * Participation in biomedical research. * Minor patient. * Protected adult patient. * Vulnerable individuals as defined by Article L1121-6 of the Public Health Code. * Pregnant or breastfeeding women. * Patient unable to express their non-opposition. * Patient refusing the collection of their personal data. * Acute, systemic, or chronic infection. Skeletal immaturity. * Grossly deformed anatomy (at the surgeon's discretion). * Osteomalacia for which the fixation of an uncemented implant is contraindicated. * Patient suffering from active rheumatoid arthritis or osteoporosis. * Patient with metabolic disorders likely to impair bone formation when the fixation of an uncemented implant is contraindicated. * Patient suffering from muscle atrophy or neuromuscular disease. * Patient with an allergy to the implant material. * Any patient who cannot or does not wish to give their informed consent to participate in the study. * Patient whose prospects of regaining independent mobility would be compromised by known coexisting medical problems. * Any contraindication mentioned in the instructions for use of the investigational medical device.

Locations (1)

Clinique de l'Union

Saint-Jean, France

RECRUITING

Outcomes

Primary Outcomes

Survival rate of SMS femoral stem

Survival analysis accordin to the Kaplan-Meier method

Time frame: From enrollment to the end of treatment at 10 years

Secondary Outcomes

Evaluation of the clinical performance of the SMS femoral stem

Clinical performance of the SMS femoral stem evaluated through the Harris Hip Score. The Harris Hip Score is a standardized measure used to assess the severity of hip pain and functional limitations in individuals with hip conditions. The maximum score possible is 100. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.

Time frame: From enrollment to the end of treatment at 10 years

Evaluation of the hip function

Hip function evaluated through the Oxford Hip Score. The Oxford Hip Score (OHS) is a short 12-item patient-reported PRO specifically designed and developed to assess function and pain with patients undergoing hip replacement surgery. The total gives a minimum score of 12 and a maximum of 60. A higher score implies a greater degree of disability.

Time frame: From enrollment to the end of treatment at 10 years

Evaluation of the quality of life

Quality of life evaluated through the EuroQol Score (EQ-5D-5L). The EQ-5D family of instruments has been developed to describe and value health across a wide range of disease areas. Each EQ-5D instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS) that are cognitively undemanding, taking only a few minutes to complete. The questionnaire provides a simple descriptive profile of a respondent's health state. The EQ VAS provides an alternative way to elicit an individual's rating of their own overall current health

Time frame: From enrollment to the end of treatment at 10 years

Evaluation of the safety (adverse events) of the SMS femoral stem

Central Contacts

Paul Maisongrosse

CONTACT

0033 05 61 37 85 93 paul.maisongrosse@hotmail.fr

Data from ClinicalTrials.gov

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