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

NCT03185663 | Completed

• 1 other identifier: I15010 / ALGOFRACT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Femoral Fractures

Outcome Measures

Primary Outcomes (1)

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

  5 minutes

Study Arms (2)

a pillow between the legs

PLACEBO COMPARATOR

Other: a pillow between the legs

traction-stuck

EXPERIMENTAL

Other: traction-stuck

Interventions

traction-stuck OTHER

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

traction-stuck

a pillow between the legs OTHER

setting up a pillow between the legs before the care

a pillow between the legs

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Limoges Hospital

Limoges, 87042, France

Location

Related Publications (1)

• https://doi.org/10.2139/ssrn.4132025

  RESULT

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a pillow between the legs versus traction-stuck

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 14, 2017
• Study Start: August 31, 2017
• Primary Completion: October 30, 2020
• Study Completion: May 25, 2021
• Last Updated: March 27, 2026

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)