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Active (not recruiting) NCT05524350

Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH)

Conditions: Hip Arthropathy

Sponsor: Societe dEtude, de Recherche et de Fabrication

trial.available_in: БГ
Overview
The use of cementless femoral stems is known to provide satisfactory long-term clinical results. Extensive and durable osseointegration of these implants has been reported in numerous series, despite the use of stems with different geometry and coating distribution. This study will validate the performance and safety of the HYPE (SERF) stems in the context of the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 (Guideline for post-marketing follow-up), which provides for a systematic procedure for monitoring clinical data in order to verify the performance claimed for medical devices.
Who can participate
Inclusion Criteria: * Male or female * Degenerative or inflammatory hip disease requiring total hip replacement * Primary or secondary osteoarthritis, * Advanced joint destruction resulting from rheumatoid arthritis or traumatic origin, * Avascular fracture or necrosis, * Displaced subcapital and transcervical fracture as well as PAPROSKY stages I to IIB bone defects. * Joint destruction of traumatic origin * Following a previous operation, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty, total arthroplasty). Exclusion Criteria: * Patient with a psychological, family, sociological or geographical situation likely to hinder compliance with the study protocol and follow-up * Known pregnancy in progress * Breastfeeding * Patient requiring a bone graft * Neurological disorders or other pathology that may influence locomotion * History of sepsis in the hip to be operated on * Short-term vital prognosis
Locations 1
France (1)
Rouen University Hospital Center
Rouen
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
05.12.2017
Completion date
20.01.2031
Registry ID
NCT05524350
Source
clinicaltrials.gov
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