Pertrochanter Arthroplasty Versus Osteosynthesis

Not Applicable

Completed

• Conditions: Pertrochanter Fracture
• Interventions: Procedure: Total hip replacement; Procedure: Osteosynthesis

• Registration Number: NCT02171897
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-24
• Study Start: 2015-01-29
• Primary Completion: 2018-10-21
• Study Completion: 2018-10-21
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients treated with total hip replacement	Total hip replacement	-
Patients treated with osteosynthesis	Osteosynthesis	-

Primary Outcome Measures

Name	Time	Method
Harris Score	At 6 months after surgery	Functional hip score

Secondary Outcome Measures

Name	Time	Method
Death rate	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	Up to 1 year after surgery	Score autonomy
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
Time to recovery of weight-bearing	Up to 1 year after surgery

Trial Locations

Locations (1)

CHU de DIJON; 🇫🇷 Dijon, France