NCT04957251

Brief Summary

Randomized trial to evaluate the role of the anterior vs posterior approach regarding hemiarthroplasty of the hip. The Investigators' hypothesis is that the muscle sparing anterior approach may result in improved function in the short term, which may allow shorter hospital stay and quicker return to prior level of function.

Trial Health

53
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2018

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

10 years

First QC Date

March 23, 2018

Last Update Submit

June 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Functional outcomes

    Harris Hip Score. Score ranges from 0-100 The higher the HHS, the less dysfunction. A total score of \<70 is considered a poor result; 70-80 is considered fair, 80-90 is good, and 90-100 is an excellent result

    1 year

Study Arms (2)

Anterior approach

EXPERIMENTAL

Patient's undergoing an anterior approach to the hip

Procedure: anterior approach to the hip

Posterior Approach

ACTIVE COMPARATOR

Patient's undergoing an posterior approach to the hip

Procedure: posterior approach to the hip

Interventions

anterior hip hemiarthroplasty

Anterior approach

posterior hip hemiarthroplasty

Posterior Approach

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Eligible patients will include all patients that were previously ambulatory at some level who sustain a displaced femoral neck fracture that given functional status, age, and comorbidities will require a hemi-arthroplasty for definitive treatment.
  • Ages 65-99

You may not qualify if:

  • Patients who will be excluded from the study are all patients who are non ambulatory at baseline.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2018

First Posted

July 12, 2021

Study Start

September 28, 2015

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Database that is kept on site that may be reviewed.