Pertrochanter Arthroplasty Versus Osteosynthesis (PAVO)

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

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.

Study Overview

• Status: Completed
• Conditions: Pertrochanter Fracture
• Intervention / Treatment: Procedure: Osteosynthesis; Procedure: Total hip replacement

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • CHU de Dijon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients treated with osteosynthesis	Procedure: Osteosynthesis
EXPERIMENTAL: Patients treated with total hip replacement	Procedure: Total hip replacement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2015
• Primary Completion (ACTUAL): October 21, 2018
• Study Completion (ACTUAL): October 21, 2018

Study Registration Dates

• First Submitted: June 18, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (ESTIMATE): June 24, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: TREMLET AOI 2013