Comparison of a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem
hype
Randomized Controlled Trial Comparing a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem
1 other identifier
interventional
160
1 country
1
Brief Summary
This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
March 9, 2018
CompletedStudy Start
First participant enrolled
March 9, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2025
CompletedApril 18, 2018
March 1, 2018
4 years
March 9, 2018
April 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
stem subsidence
stem subsidence will be measured using the EBRA (Ein-Bild-Rontgen-analyse) software on postoperative antero-posterior radiographs (5 xrays from day one to year 2)
2 years postop
Secondary Outcomes (1)
Intraoperative surgeon satisfaction
intraoperative
Other Outcomes (12)
intraoperative proportion of patients requiring a blood transfusion
at time of hospital discharge, at approximately 2 days
postoperative PMA (Postel Merle d'Aubigné) score after hospital discharge
3 months, 1 year, 2 years, 5 years
postoperative Oxford hip score after hospital discharge
3 months, 1 year, 2 years, 5 years
- +9 more other outcomes
Study Arms (2)
hype standard
ACTIVE COMPARATORtotal hip replacement with standard femoral stem
hype mini
EXPERIMENTALtotal hip replacement with short uncemented femoral stem
Interventions
total hip replacement with standard femoral stem
total hip replacement with short femoral stem
Eligibility Criteria
You may qualify if:
- hip osteoarthritis requiring a total hip replacement
- \>18 years old
- agrees to participate
You may not qualify if:
- total hip replacement not indicated
- general anesthesia contraindicated
- previous surgery on the ipsilateral femur
- follow-up not possible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital Cochin
Paris, Île-de-France Region, 75014, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David BIAU, MD
Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- implant
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 9, 2018
First Posted
April 18, 2018
Study Start
March 9, 2018
Primary Completion
March 9, 2022
Study Completion
March 9, 2025
Last Updated
April 18, 2018
Record last verified: 2018-03