IMPLICATION OF FAST-TRACK PROTOCOL FOR HIP FRACTURE FIXATION IN ALEXANDRIA UNIVERSITY HOSPITALS

NCT06881121 | Completed Phase 4 DMC

• 1 other identifier: IMPLICATION OF FAST-TRACK
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to evaluate the impact of fast-track protocol of hip fracture fixation within 48 hours on patients' mortality and morbidities. Primary aim is to observe the incidence of 30-day mortality of patients with hip fractures admitted to the operating room (OR) for fixation within 48 hours of the trauma event and to asses Deep vein thrombosis incidence, Pulmonary embolism incidence, Post-operative cognitive dysfunction, length of hospital stay.,Length of ICU stay,Patients who needed hospital readmission and the reasons and the success of the postoperative rehabilitation status.

Conditions

Fast-track Protocol; Hip Fracture; 30 Days Mortality

Outcome Measures

Primary Outcomes (1)

• 30 days mortality

  Mortality: The follow-up time will be 30 days either through postoperative visits or phone call and documented. Time to death will be calculated from admission to possible event.

  30 days post operative

Secondary Outcomes (16)

• Time to surgery

  Hours before surgery

• Duration of surgery

  During Surgery

• Deep vein thrombosis incidence

  Post opertaive day 5

• Pulmonary embolism incidence

  Post operative day 5

• Thromboembolic complications

  Post opertaive day 5

Study Arms (2)

Group Fast pathway

EXPERIMENTAL

Group Fast pathway: Seventy-five patients treated according to fast-track protocol.

Procedure: Fast-track protocol for hip fracture fixation

Group Conventional pathway

NO INTERVENTION

Group Conventional pathway: Seventy-five patients who failed to be included in the fast track protocol will be included in the conventional (Non-Fast) pathway.

Interventions

Fast-track protocol for hip fracture fixation PROCEDURE

Fast-track protocol implication on mortality and morbidities in hip fracture fixation

Group Fast pathway

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years.
• ASA physical status class I, II or III.

You may not qualify if:

• Poly-trauma patients.
• Patients with history of sensitivity to the studied drugs.
• Psychiatric disease or seizure disorder requiring medication within the previous 2 years.
• Opioid tolerant patients.
• Patients with preoperative cognitive dysfunction.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of medicine Alexandria University

Alexandria, Egypt, Alexandria Governorate, Egypt

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Moustafa Abdelaziz Ahmed, MD

  Alexandria University

  STUDY DIRECTOR

• Maher Doghiem, MD

  Alexandria University

  STUDY DIRECTOR

• Ahmed Shehab, MD

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer Alexandria University

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 18, 2025
• Study Start: April 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 years
• Access Criteria: Fast-track Hip fracture fixation

Locations

EG (1)