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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 (ALGOFRACT)

Primary Purpose

Femoral Fractures

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
traction-stuck
a pillow between the legs
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Femoral Fractures

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Limoges Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

a pillow between the legs

traction-stuck

Arm Description

Outcomes

Primary Outcome Measures

Score from pain immediately after washing, the day of surgery preoperatively

Secondary Outcome Measures

Full Information

First Posted
June 12, 2017
Last Updated
December 8, 2021
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT03185663
Brief Title
Pilot Study Comparing Two Techniques of Taking Care Analgesic in Patients 70 and Older, Awaiting Surgery After Extracapsular Fracture of the Proximal Femur
Acronym
ALGOFRACT
Official Title
Pilot Study Comparing Two Techniques of Taking Care Analgesic in Patients 70 and Older, Awaiting Surgery After Extracapsular Fracture of the Proximal Femur
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
May 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Fractures

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a pillow between the legs versus traction-stuck
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
a pillow between the legs
Arm Type
Placebo Comparator
Arm Title
traction-stuck
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
traction-stuck
Intervention Description
continuous pulling method: tensile force is exerted directly on the skin by means of adhesive strips, connected to weight
Intervention Type
Other
Intervention Name(s)
a pillow between the legs
Intervention Description
setting up a pillow between the legs before the care
Primary Outcome Measure Information:
Title
Score from pain immediately after washing, the day of surgery preoperatively
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Limoges Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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