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

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

Study Overview

• Status: Completed
• Conditions: Femoral Fractures
• Intervention / Treatment: Other: a pillow between the legs; Other: traction-stuck

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • Limoges hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: a pillow between the legs	Other: a pillow between the legs; setting up a pillow between the legs before the care
Experimental: traction-stuck	Other: traction-stuck; continuous pulling method: tensile force is exerted directly on the skin by means of adhesive strips, connected to weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Score from pain immediately after washing, the day of surgery preoperatively	5 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2017
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): May 25, 2021

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: I15010 / ALGOFRACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No