Prospective and Obsevational Study of Total Hip Prothesis: HYPE Stem

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: NCT05560022
• Other study ID #: 2017-01-NH-HYPE-Novae
• Status: Active, not recruiting
• Start date: December 5, 2017
• Est. completion date: January 20, 2031

Study information

• Verified date: April 2023
• Source: Societe dEtude, de Recherche et de Fabrication
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 .

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: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Locations

Country	Name	City	State
France	CHU de ROUEN	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	Assess the Survival rate to Total Hip Prothesis combining a HYPE stem and a SERF cup in hip replacements	Survival according to Kaplan Meier	per operative period to 10 years
Secondary	Assess the improvement in PMA scores and HHS score as well as patient satisfaction		per operative period to 10 years
Secondary	Adverse events	Type and occurrence of adverse events	per operative period to 10 years
Secondary	Patient satisfaction		per operative period to 10 years