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

Femoral Fractures Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185663
• Other study ID #: I15010 / ALGOFRACT
• Status: Completed
• Phase: N/A
• Start date: August 31, 2017
• Est. completion date: May 25, 2021

Study information

• Verified date: November 2020
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 25, 2021
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone

Intervention

Other:
• traction-stuck
continuous pulling method: tensile force is exerted directly on the skin by means of adhesive strips, connected to weight
• a pillow between the legs
setting up a pillow between the legs before the care

Locations

Country	Name	City	State
France	Limoges Hospital	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score from pain immediately after washing, the day of surgery preoperatively		5 minutes