Pertrochanter Arthroplasty Versus Osteosynthesis

NCT ID: NCT02171897

Last Updated: 2019-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-29

Study Completion Date

2018-10-21

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.

Detailed Description

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Conditions

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Pertrochanter Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Patients treated with osteosynthesis

Group Type EXPERIMENTAL

Osteosynthesis

Intervention Type PROCEDURE

Patients treated with total hip replacement

Group Type EXPERIMENTAL

Total hip replacement

Intervention Type PROCEDURE

Interventions

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Osteosynthesis

Intervention Type PROCEDURE

Total hip replacement

Intervention Type PROCEDURE

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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de DIJON

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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TREMLET AOI 2013

Identifier Type: -

Identifier Source: org_study_id

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