Prospective and Obsevational Study of Total Hip Prothesis: HYPE Stem

Study Research and Manufacturing Company (SERF)

Status: Active, not recruiting

Conditions: Hip Arthropathy

Study type: Observational

Funder types: Industry

Identifiers

NCT05560022

2017-01-NH-HYPE-Novae

Details and patient eligibility

About

The purpose of this study is to validate the performance and the safety of the HYPE (SERF) prothesis in compliance with the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 guide ( guideline for post-market follow-up), which provides for the implementation of a systematic procedure for the follow-up of 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

• Man or women
• Degenerative or inflammatory hip pathology requiring a total hip replacement
• Primary or secondary osteoarthritis
• Advanced joint destruction resulting from rhumatoid arthritis or traumatic arthritis
• Fracture or avascular necrosis
• Sub-capital fracture and displaced transcervical as well as for bone defects stages I to IIb of PAPROSKY
• Traumatic joint destruction
• Following previous intervention, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty, total arthroplasty

Exclusion criteria

• People with diminished mental faculties
• Known current pregnancy
• Breast-feeding
• Neurological disorders or other pathologies that may influence locomotion
• Septic antecedent on hip to operate
• Patient requiring a bone graft