NCT05560022

Brief 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 .

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
54mo left

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Dec 2017Jan 2031

Study Start

First participant enrolled

December 5, 2017

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2031

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

13.1 years

First QC Date

September 26, 2022

Last Update Submit

April 21, 2026

Conditions

Hip Arthropathy

Keywords

Total Hip Prothesis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Assess the improvement in PMA scores and HHS score as well as patient satisfaction

    per operative period to 10 years

  • Adverse events

    per operative period to 10 years

  • Patient satisfaction

    per operative period to 10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The implantation of the total hip prothesis will be performed in patients with a hip pathology in the first intention or during total prothesis revision

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de ROUEN

Rouen, 76000, France

Location
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2022

First Posted

September 29, 2022

Study Start

December 5, 2017

Primary Completion (Estimated)

January 20, 2031

Study Completion (Estimated)

January 20, 2031

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

FR(1)