Pertrochanter Fracture
Conditions
Brief summary
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.
Interventions
PROCEDUREOsteosynthesis
PROCEDURETotal hip replacement
Sponsors
Centre Hospitalier Universitaire Dijon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Score | At 6 months after surgery | Functional hip score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| PMA functional score | Up to 1 year after surgery | Functional score |
| 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 | — |
| Parker score | Up to 1 year after surgery | Score autonomy |
Countries
France
Outcome results
None listed