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Pertrochanter Arthroplasty Versus Osteosynthesis (PAVO)

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Pertrochanter Fracture

Treatments

Procedure: Osteosynthesis
Procedure: Total hip replacement

Study type

Interventional

Funder types

Other

Identifiers

NCT02171897
TREMLET AOI 2013

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

Patients treated with osteosynthesis
Experimental group
Treatment:
Procedure: Osteosynthesis
Patients treated with total hip replacement
Experimental group
Treatment:
Procedure: Total hip replacement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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