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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)
trial in Hip Arthropathy in 180 participants. Participants enrolled and being followed up; not accepting new ones.
20 January 2031
Quick facts
| Lead sponsor | Societe dEtude, de Recherche et de Fabrication |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 180 |
| Start date | 5 December 2017 |
| Primary completion | 20 January 2031 |
| Estimated completion | 20 January 2031 |
| Sites | 1 location across France |
Conditions studied
- Hip Arthropathy — all drugs for Hip Arthropathy →
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.
Verify or expand the search:
- PubMed search for NCT05524350
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Societe dEtude, de Recherche et de Fabrication trials
Trials by the same sponsor.
- NCT06917365 — Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups · recruiting
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- NCT06096155 — Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem · unknown
- NCT06096168 — Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems · completed
- NCT05876143 — Ambispective Multicentric Study Evaluating UKA With U-Knee/Uni-Kroma Implants · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05524350 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Societe dEtude, de Recherche et de Fabrication
- Last refreshed: 17 March 2025
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