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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05524350
Other study ID # 2017-A03359-44
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 5, 2017
Est. completion date January 20, 2031

Study information

Verified date October 2023
Source Societe dEtude, de Recherche et de Fabrication
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 180
Est. completion date January 20, 2031
Est. primary completion date January 20, 2031
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Rouen University Hospital Center Rouen

Sponsors (1)

Lead Sponsor Collaborator
Societe dEtude, de Recherche et de Fabrication

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival rate Survival rate for failure at 10 years by studying in particular the intraosseous behaviour of the stem (femoral implant) and of the acetabulum (acetabular or acetabular implant) with the help of radiological examinations: appearance or not of lines, osseointegration, migration, possible loosening, realignment. Per operative period to 10 years
Secondary Functional improvement The information will be collected through questionnaires to compare preoperatively situtation to last follow-up situtation Per operative period to 10 years
Secondary Pain release The information will be collected through questionnaires to compare preoperatively situtation to last follow-up situtation Per operative period to 10 years
Secondary Patient satisfaction The information will be collected from patient through questionnaires to compare preoperatively situtation to last follow-up situtation Per operative period to 10 years
Secondary Adverse event Type and occurence of adverse events Per operative period to 10 years
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