Clinical trial NCT03500926: Comparison of a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem
Official title: Randomized Controlled Trial Comparing a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Hip
Lead sponsor: Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized 1/1 comparison
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: stem subsidence
timeFrame: 2 years postop
Secondary outcomes:
measure: Intraoperative surgeon satisfaction
timeFrame: intraoperative
Other outcomes:
measure: intraoperative proportion of patients requiring a blood transfusion
timeFrame: at time of hospital discharge, at approximately 2 days
measure: postoperative PMA (Postel Merle d'Aubigné) score after hospital discharge
timeFrame: 3 months, 1 year, 2 years, 5 years
measure: postoperative Oxford hip score after hospital discharge
timeFrame: 3 months, 1 year, 2 years, 5 years
measure: scar assessement
timeFrame: 3 months, 1 year, 2 years, 5 years
measure: hip pain
timeFrame: 3 months, 1 year, 2 years, 5 years
measure: thigh pain
timeFrame: 3 months, 1 year, 2 years, 5 years
measure: revision of hip replacement
timeFrame: at 5 years
measure: radiological outcome - engh score
timeFrame: 2 years
measure: radiological outcome - ARA (AGORA Roentgenographic Assessment) score
timeFrame: 2 years
measure: in hospital morphine consumption
timeFrame: postop day 1
measure: in hospital blood transfusion
timeFrame: until discharge from hospital, at approximately 2 days
measure: duration of hospital stay
timeFrame: until discharge from hospital, at approximately 2 days
Locations:
city: Paris
country: France
facility: Hopital Cochin
state: Ile De France
Study officials:
affiliation: Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
name: David BIAU, MD
role: PRINCIPAL_INVESTIGATOR
References: