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

Study Research and Manufacturing Company (SERF)

Status: Active, not recruiting

Conditions: Hip Arthropathy

Study type: Observational

Funder types: Industry

Identifiers

NCT05524350

2017-A03359-44

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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