Pertrochanter Arthroplasty Versus Osteosynthesis

Study Overview
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Brief Summary
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This is a single-centre, comparative, prospective randomised trial. It will include 70 patients over a period of 2 years randomized into two groups of 35 patients: one group of patients treated with osteosynthesis (plate, nail or screw) and the second group treated with total hip replacement. The Harris and PMA functional scores will be assessed at 6 weeks, 3 months, 6 months and 1 year. The time to recovery of weight-bearing, the subjective satisfaction score, the EQ5D quality of life questionnaire, the VAS score for pain at rest and when walking, the Parker score, the rate of complications and deaths will also be measured. Operating time, blood loss and scar size will also be evaluated.

Official Title
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Comparison of Functional Recovery After Pertrochanter Fracture Treated With Either Total Hip Replacement or Centromedullary Nailing

Conditions
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Pertrochanter Fracture

Intervention / Treatment
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* Procedure: Osteosynthesis
* Procedure: Total hip replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have provided written informed consent Patients over 18 years old Patients less than 70 years old Patient presenting with a fracture of the trochanter (type 1 to 6 according to the Ender classification, and A1 and A2 according tyo the AO classification (Association suisse pour l'étude de l'Ostéosynthèse : classification internationale) Exclusion Criteria: Adult under guardianship Patients not covered by national health insurance Pregnant or breast-feeding women Unable to walk independently before the trauma Patients with dementia

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients treated with osteosynthesis<br> | Procedure: Osteosynthesis<br> <br> |
| Experimental: Patients treated with total hip replacement<br> | Procedure: Total hip replacement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Score | Functional hip score | At 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PMA functional score | Functional score | Up to 1 year after surgery | 
| Time to recovery of weight-bearing |  | Up to 1 year after surgery | 
| Subjective satisfaction score (EQ5D, VAS score for pain at rest and when walking) |  | Up to 1 year after surgery | 
| Parker score | Score autonomy | Up to 1 year after surgery | 
| Rate of complications (loosening of implants, fractures around osteosynthesis devices or prostheses, infections, phlebitis-pulmonary embolism) |  | Up to 1 year after surgery | 
| Death rate |  | Up to 1 year after surgery |