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NCT05524350

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

Active, enrolled Last updated 17 March 2025
What this trial tests

trial in Hip Arthropathy in 180 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
5 December 2017
Primary endpoint
20 January 2031
20 January 2031

Quick facts

Lead sponsorSociete dEtude, de Recherche et de Fabrication
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment180
Start date5 December 2017
Primary completion20 January 2031
Estimated completion20 January 2031
Sites1 location across France

Conditions studied

Sponsor

Societe dEtude, de Recherche et de Fabrication

Who can join

18 and older, any sex, with Hip Arthropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Hip Arthropathy

Currently open trials in the same condition.

Other Societe dEtude, de Recherche et de Fabrication trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05524350.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing