Clinical trial NCT05524350: Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH)
Official title: Study of the Total Hip Prosthesis With a HYPE Stem in Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hip Arthropathy
Keywords: Total Hip Arthroplasty
Lead sponsor: Societe dEtude, de Recherche et de Fabrication
Sponsor class: INDUSTRY
First posted: 2022-09-01
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The expected number of patients in the registry is estimated at 180 patients.The implantation of the total hip prosthesis will be carried out in patients with a hip pathology, in first intention or during a total prosthesis revision. The implant placement will be performed on a continuous series of patients by the investigator according to the eligibility criteria. Post-operative follow-up will be carried out for ten days following the operation, in the hospital concerned. Successive clinical and radiological evaluations will be performed at a date set by the investigator.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Survival rate
timeFrame: Per operative period to 10 years
Secondary outcomes:
measure: Functional improvement
timeFrame: Per operative period to 10 years
measure: Pain release
timeFrame: Per operative period to 10 years
measure: Patient satisfaction
timeFrame: Per operative period to 10 years
measure: Adverse event
timeFrame: Per operative period to 10 years
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital Center
Study officials:
References: