Osteoarthritis, Hip
Conditions
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.
Interventions
DEVICEtotal hip replacement - standard femoral stem
total hip replacement with standard femoral stem
DEVICEtotal hip replacement - short femoral stem
total hip replacement with short femoral stem
Sponsors
Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
implant
Intervention model description
randomized 1/1 comparison
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative surgeon satisfaction | intraoperative | measurement of surgeon's satisfaction with using the instrumentation to insert the stem; on a Likert scale intraoperative complication |
Other
| Measure | Time frame | Description |
|---|---|---|
| postoperative Oxford hip score after hospital discharge | 3 months, 1 year, 2 years, 5 years | oxford hip score |
| scar assessement | 3 months, 1 year, 2 years, 5 years | patient specific index |
| hip pain | 3 months, 1 year, 2 years, 5 years | measurement of hip pain on a Likert scale |
| thigh pain | 3 months, 1 year, 2 years, 5 years | measurement of thigh pain on a Likert scale |
| revision of hip replacement | at 5 years | cumulative incidence of revision at 5 years (Cox model) |
| intraoperative proportion of patients requiring a blood transfusion | at time of hospital discharge, at approximately 2 days | proportion of patients requiring a blood transfusion during the procedure |
| radiological outcome - ARA (AGORA Roentgenographic Assessment) score | 2 years | ARA score |
| in hospital morphine consumption | postop day 1 | total dose of morphine used in recovery room and until day one |
| in hospital blood transfusion | until discharge from hospital, at approximately 2 days | proportion of patients requiring a blood transfusion during hospitalisation |
| duration of hospital stay | until discharge from hospital, at approximately 2 days | length of hospitalisation in days |
| radiological outcome - engh score | 2 years | Engh score |
| postoperative PMA (Postel Merle d'Aubigné) score after hospital discharge | 3 months, 1 year, 2 years, 5 years | PMA score |
Countries
France
Contacts
Primary ContactDavid BIAU, MD
Outcome results
None listed