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This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hype standard | Active Comparator | total hip replacement with standard femoral stem |
|
| hype mini | Experimental | total hip replacement with short uncemented femoral stem |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total hip replacement - standard femoral stem | Device | total hip replacement with standard femoral stem |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative surgeon satisfaction | measurement of surgeon's satisfaction with using the instrumentation to insert the stem; on a Likert scale intraoperative complication | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative proportion of patients requiring a blood transfusion | proportion of patients requiring a blood transfusion during the procedure | at time of hospital discharge, at approximately 2 days |
| postoperative PMA (Postel Merle d'Aubigné) score after hospital discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David BIAU, MD | Contact | +33158413037 | secretatiat.biau.cch@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| David BIAU, MD | Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Cochin | Recruiting | Paris | ÃŽle-de-France Region | 75014 | France |
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randomized 1/1 comparison
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implant
| total hip replacement - short femoral stem | Device | total hip replacement with short femoral stem |
|
PMA score |
| 3 months, 1 year, 2 years, 5 years |
| postoperative Oxford hip score after hospital discharge | oxford hip score | 3 months, 1 year, 2 years, 5 years |
| scar assessement | patient specific index | 3 months, 1 year, 2 years, 5 years |
| hip pain | measurement of hip pain on a Likert scale | 3 months, 1 year, 2 years, 5 years |
| thigh pain | measurement of thigh pain on a Likert scale | 3 months, 1 year, 2 years, 5 years |
| revision of hip replacement | cumulative incidence of revision at 5 years (Cox model) | at 5 years |
| radiological outcome - engh score | Engh score | 2 years |
| radiological outcome - ARA (AGORA Roentgenographic Assessment) score | ARA score | 2 years |
| in hospital morphine consumption | total dose of morphine used in recovery room and until day one | postop day 1 |
| in hospital blood transfusion | proportion of patients requiring a blood transfusion during hospitalisation | until discharge from hospital, at approximately 2 days |
| duration of hospital stay | length of hospitalisation in days | until discharge from hospital, at approximately 2 days |
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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