Comparison of a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem

Not Applicable

Recruiting

• Conditions: Osteoarthritis, Hip
• Interventions: Device: total hip replacement - standard femoral stem; Device: total hip replacement - short femoral stem

• Registration Number: NCT03500926
• Lead Sponsor: Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique

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.

Detailed Description

This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.

Patients will be randomized a few days before the operation. At the time of surgery, the surgeon will use the relevant implant. Patients will be followed up for 5 years after surgery. The main outcome criteria is the stem subsidence measured radiographically with a dedicated software.

Study Timeline

• Status Verified: 2018-03
• Study Start: 2018-03-09
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-04-10
• Last Update Submitted: 2018-04-10
• Study First Posted: 2018-04-18
• Last Update Posted: 2018-04-18
• Primary Completion: 2022-03-09
• Study Completion: 2025-03-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• hip osteoarthritis requiring a total hip replacement
• >18 years old
• agrees to participate

Exclusion Criteria

• total hip replacement not indicated
• general anesthesia contraindicated
• previous surgery on the ipsilateral femur
• follow-up not possible

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hype standard	total hip replacement - standard femoral stem	total hip replacement with standard femoral stem
hype mini	total hip replacement - short femoral stem	total hip replacement with short uncemented femoral stem

Primary Outcome Measures

Name	Time	Method
stem subsidence	2 years postop	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)

Secondary Outcome Measures

Name	Time	Method
Intraoperative surgeon satisfaction	intraoperative	measurement of surgeon's satisfaction with using the instrumentation to insert the stem; on a Likert scale intraoperative complication

Trial Locations

Locations (1)

Hopital Cochin; 🇫🇷 Paris, Ile De France, France