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

Hip Arthropathy Clinical Trial

Official title:

Study of the Total Hip Prosthesis With a HYPE Stem in Hip Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05524350
• Other study ID #: 2017-A03359-44
• Status: Active, not recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

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