Comparison of a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem (hype)

Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique

Status: Enrolling

Conditions: Osteoarthritis, Hip

Treatments: Device: total hip replacement - short femoral stem; Device: total hip replacement - standard femoral stem

Study type: Interventional

Funder types: Other

Identifiers

NCT03500926

2017-A03215-48

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

hype standard

Active Comparator group

Description:

total hip replacement with standard femoral stem

Treatment:

Device: total hip replacement - standard femoral stem

hype mini

Experimental group

Description:

total hip replacement with short uncemented femoral stem

Treatment:

Device: total hip replacement - short femoral stem