NCT07501741

Brief Summary

The goal of this clinical trial is to learn whether the surgical approach used for hemiarthroplasty can improve clinical and functional outcomes in adults with displaced femoral neck fractures. The main questions it aims to answer are:

  • Does the direct anterior approach (DAA) result in superior postoperative functional recovery compared with the direct lateral approach (DLA)?
  • Are mortality, complications, hospital utilization, and readmission rates different between the two surgical approaches? Researchers will compare hemiarthroplasty performed using the direct anterior approach to hemiarthroplasty performed using the direct lateral approach to determine whether surgical approach influences postoperative function, complications, and survival. Participants will:
  • Undergo hemiarthroplasty for displaced femoral neck fracture using a randomly assigned surgical approach (DAA or DLA)
  • Complete a baseline functional assessment using the Activities of Daily Living (ADL) questionnaire before surgery
  • Have perioperative data collected during hospitalization, including laboratory values, operative details, blood loss, transfusions, analgesic use, complications, length of stay, and in-hospital mortality
  • Attend follow-up clinic visits at 6 weeks and 3 months after surgery
  • Complete postoperative functional assessment using the Harris Hip Score at both follow-up visits
  • Have demographic data, complications, readmissions, and mortality monitored through review of electronic medical records

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
22mo left

Started May 2026

Status
not yet recruiting

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 Progress6%
May 2026May 2028

First Submitted

Initial submission to the registry

March 16, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 16, 2026

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Harris Hip Score (HHS) - Postoperative Functional Outcome at 6 Weeks and 3 Months Following Hemiarthroplasty

    Functional outcome will be assessed using the Harris Hip Score (HHS), a validated 100-point scale evaluating pain, function, deformity, and range of motion, collected at 6 weeks and 3 months postoperatively.

    6 weeks and 3 months post-surgery

Secondary Outcomes (1)

  • Incidence of Treatment-Related Complications Following Hemiarthroplasty

    During hospitalization and up to 3 months post-surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adult patients undergoing hemiarthroplasty for displaced femoral neck fracture at Meir Medical Center during the study period.

You may qualify if:

  • Adults aged 18 years or older Patients undergoing hemiarthroplasty (partial hip replacement) during the study period at Meir Medical Center Ability to provide informed consent for participation in the study

You may not qualify if:

  • Revision surgery performed during the index hospitalization Inability to complete postoperative follow-up Inability to provide informed consent (e.g., dementia or presence of a legal guardian) Pre-injury mobility status of bedbound or wheelchair-bound Polytrauma patients Prior fixation or arthroplasty of the contralateral hip within the previous year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 30, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03