NCT06056934

Brief Summary

Today, the standard treatment is to operate on patients suffering from a fracture of the upper end of the femur. The aim of treatment is to enable immediate mobilization and weight-bearing, and as rapid a return as possible to normal living conditions. Surgery is the best treatment option. It maximizes the chances of functional recovery and, by stabilizing the fracture, reduces pain: it is the most effective and longest-lasting analgesic. Adequate analgesia in elderly patients with femoral neck fractures has a beneficial effect. In particular, a lower probability of death has been shown in cervical fracture patients receiving opioids than those not receiving them. Pain management is a matter of protocol in the UPOG department of the CHU de Nîmes. Pain prevention appears to improve morbidity and mortality. Cognitive fragility, such as neurocognitive disorders, confusion or long-term use of psychotropic drugs, appear to be confounding factors in pain management. The investigators therefore wished to observe whether the presence of cognitive fragility has an impact on pain management on the ward, despite protocol-based management.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

June 22, 2023

Last Update Submit

March 7, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Morphine sulfate equivalent rate in each group, mg/day

    mg/day

    Pre-operative

  • Morphine sulfate equivalent rate in each group, mg/day

    mg/day

    Early post-operative between Day 0 and Day 3

  • Morphine sulfate equivalent rate in each group, mg/day

    mg/day

    Late post-operative between Day 4 and day 7

Eligibility Criteria

Age76 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients hospitalized at UPOG for fracture of the upper end of the femur between January 1 and December 31, 2022.

You may qualify if:

  • Patients aged \> 75 years
  • Hospitalized for a fracture of the upper extremity of the femur at the UPOG of the CHU de Nîmes during 2022

You may not qualify if:

  • Opioid allergy
  • No surgical management of fracture
  • Long-term treatment with high-dose opiates
  • Patient has objected to the use of his or her data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GAULTIER

Nîmes, CHU de Nîmes, 30029, France

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2023

First Posted

September 28, 2023

Study Start

March 9, 2023

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

March 10, 2025

Record last verified: 2025-03

Locations