ExceptionNCT04349046
Exception Cementless Hip Stem
At risk: Primary completion moved 12 months later.
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Record History
All 10 versions: 7 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗
- Notable Primary completion pushed from May 1, 2024 to May 1, 2025
- Eligibility criteria expanded, about 15 words
- Study completion pushed from Dec 2025 to Dec 2026
- Secondary endpoints: details revised at 3 of 4 entries
- Minor Trial status: Recruiting to Active, Not Recruiting
- Site details revised at 6 of 6 sites
- Notable Trial status: Not Yet Recruiting to Recruiting
- Site details revised at 6 of 6 sites
- Notable Start date: Aug 1, 2020 to Jan 1, 2021v4
- Notable Start date: May 1, 2020 to Aug 1, 2020v3
- Minor Secondary endpoints: details revised at 2 of 4 entriesv2
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
Timeframe: 10 years post-surgery
Secondary (4)
Pain and functional performance based on the Harris Hip Score
Subject quality-of-life determined by the EQ-5D (EuroQoI) score
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc
Safety based on eventual complications occurred including dislocations and revisions/removals
Arms and interventions
Patient who received the Exception stem
Patient who received the Exception stem between January 2008 and September 2012 and consented to the original data collection.
Devices: Total hip arthoplasty (THA)
Sites
6 sites in 2 countries
France 5, Belgium 1