NCT07409909

Brief Summary

Femoral neck fracture (FNF) is a worldwide health problem that can cause significant morbidity and mortality. Most femoral neck fractures are associated with a fall, and the risk factors include osteoporosis, chronic medication use, and reduced level of activity. Femoral neck fractures are among the most common injuries in the elderly, and their number continues to increase with a more aged population. In the elderly, femoral neck fractures may lead to significant mortality and morbidity, with impaired mobility and loss of independence. Given their high incidence and associated detrimental effects on patient lives. The femoral neck fracture is a major type of hip fracture, whose treatment includes internal fixation, hemiarthroplasty (HA), or total hip arthroplasty (THA). The decision depends on multiple variables, including fracture pattern, surgeon comfort, and the patient's age, health, and ambulatory status. Internal fixation is a preferred management option for young people or the elderly who are intolerant of prosthesis surgery. THA and HA are widely used in displaced femoral neck fractures in the elderly. Surgery in these patients is undertaken to facilitate nursing and provide timely pain relief, rapid mobilization, and accelerated rehabilitation In general, HA has the advantages of shorter operation time, less blood loss, less technical demand, less economic burden, and a lower dislocation rate. However, some patients treated with HA require conversion to THA due to complications such as acetabular erosion. THA, on the other hand, has been associated with superior patient satisfaction and better hip function, less acetabular erosion, and a lower revision rate. However, increased surgical complexity, operation time, and blood loss, as well as higher dislocation rates in THA for FNFs, remain a concern

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

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

January 2, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

February 7, 2026

Last Update Submit

February 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • functional improvement

    will be assessed via modified Harris Hip Score. The score is calculated based on four parameters: pain (0-44 points), function (0-47 points), absence of deformity (0-4 points), and range of motion (0-5 points).

    12 months

Study Arms (2)

Total Hip Arthroplasty

EXPERIMENTAL
Procedure: Total Hip Arthroplasty

Bipolar Hemiarthroplasty

ACTIVE COMPARATOR
Procedure: Bipolar Hemiarthroplasty

Interventions

Patients will have total hip arthroplasty for managing neck femur fracture

Total Hip Arthroplasty

Patients in the control group with femur fracture will have bipolar hemiarthroplasty

Bipolar Hemiarthroplasty

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • were aged ≥ 65 years
  • with a displaced intracapsular fracture of the femoral neck (Garden type III, IV).

You may not qualify if:

  • extracapsular fracture of the femoral neck
  • Pathological fractures, or open fractures
  • Active infections at or near the hip joints.
  • bedridden, immobile, or cognitively impaired patients
  • patients with associated pelvic or acetabular fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, for Girls, Al-Zhar University, Egpyt

Cairo, Egypt

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 13, 2026

Study Start

January 2, 2023

Primary Completion

January 1, 2026

Study Completion

January 15, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations