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Pilot Study Comparing Two Techniques of Taking Care Analgesic in Patients 70 and Older, Awaiting Surgery After Extracapsular Fracture of the Proximal Femur

NCT ID: NCT03185663

Last Updated: 2021-12-09

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2021-05-25

Brief Summary

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The fracture of the proximal femur is a common traumatic pathology in patients aged over 70 years, associated with a mortality of 20 to 30% a year. The care is delayed emergency. During this wait, the occurrence of heel pressure ulcers is regularly found, despite wearing antiescarres slippers. Mobilization, source of pain, is also problematic.

759/5000

Detailed Description

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Conditions

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Femoral Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a pillow between the legs versus traction-stuck
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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a pillow between the legs

Group Type PLACEBO_COMPARATOR

a pillow between the legs

Intervention Type OTHER

setting up a pillow between the legs before the care

traction-stuck

Group Type EXPERIMENTAL

traction-stuck

Intervention Type OTHER

continuous pulling method: tensile force is exerted directly on the skin by means of adhesive strips, connected to weight

Interventions

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traction-stuck

continuous pulling method: tensile force is exerted directly on the skin by means of adhesive strips, connected to weight

Intervention Type OTHER

a pillow between the legs

setting up a pillow between the legs before the care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient aged 70 and over,
* Extracapsular fracture isolated from the proximal end of the femur,
* Informed consent of the patient for participation in the study,
* Patient affiliated to a social security scheme.

Exclusion Criteria

* Restlessness or fragile skin condition that may prevent the establishment or maintenance of traction stuck preoperatively
* Insane or confounding Pathology,
* Predictable time before operation\> to 72 hours (eg anticoagulated patient orally before the fracture \[antiplatelet agents are allowed\], other associated diseases: urinary tract infection, pneumonia ...)
* Patient under guardianship, curatorship, or under judicial protection.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Limoges Hospital

Limoges, , France

Site Status

Countries

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France

Other Identifiers

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I15010 / ALGOFRACT

Identifier Type: -

Identifier Source: org_study_id