NCT07345182

Brief Summary

This prospective, single-center, randomized clinical trial compared the clinical and functional outcomes of hemiarthroplasty performed via lateral versus posterior surgical approaches in elderly patients with displaced intracapsular femoral neck fractures. The primary objective was to compare prosthetic dislocation and intraoperative femoral fracture rates between the two approaches. Secondary outcomes included functional scores, radiological parameters, complications, and mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

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

March 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

3.1 years

First QC Date

December 23, 2025

Last Update Submit

January 8, 2026

Conditions

Keywords

Lateral HemiarthroplastyPosterior HemiarthroplastySurgical ApproachFunctional OutcomeHarris Hip ScoreParker and Palmer Mobility Score

Outcome Measures

Primary Outcomes (1)

  • Prosthetic dislocation rate

    Incidence of postoperative prosthetic hip dislocation following hemiarthroplasty.

    Within 12 months postoperatively

Secondary Outcomes (4)

  • Intraoperative periprosthetic femoral fracture rate

    During surgery

  • Harris Hip Score (HHS)

    Preoperative baseline and final follow-up at minimum 12 months postoperatively

  • Parker and Palmer Mobility Score (PPMS) change

    Preoperative baseline and final follow-up at minimum 12 months postoperatively

  • One-year mortality

    Within 12 months postoperatively

Study Arms (2)

Lateral Approach Group

EXPERIMENTAL

Patients underwent hemiarthroplasty using the direct lateral surgical approach.

Procedure: Lateral approach hemiarthroplasty

Posterior Approach Group

EXPERIMENTAL

Patients underwent hemiarthroplasty using the posterior surgical approach.

Procedure: Posterior approach hemiarthroplasty

Interventions

Hemiarthroplasty performed using the lateral surgical approach.

Lateral Approach Group

Hemiarthroplasty performed using the posterior surgical approach.

Posterior Approach Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60 years or older
  • Displaced intracapsular femoral neck fracture
  • Treated with hemiarthroplasty
  • Ability to provide informed consent by the patient or a legal representative

You may not qualify if:

  • Pathological femoral neck fractures
  • Previous surgery on the affected hip
  • Polytrauma patients
  • Periprosthetic fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ümraniye Training and Research Hospital

Istanbul, Umraniye, 34764, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Femoral Neck FracturesHip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study was conducted as an open-label trial. Due to the nature of the surgical interventions, blinding of surgeons and participants was not feasible.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1 ratio to one of two parallel groups to undergo hemiarthroplasty using either the lateral or the posterior surgical approach. Each participant received only the assigned intervention.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 15, 2026

Study Start

March 1, 2016

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations