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Procedure

Hip Surgery Options for Femoral Neck Fracture

N/A

Recruiting

Led By Gerard Slobogean, MD

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients 60 years of age or older.

Complete fracture of the femoral neck (AO/OTA 31B) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare hip surgery options for older adults with a type of hip fracture. Patients will be followed for 1 year.

Who is the study for?

This study is for adults aged 60 or older with a specific type of hip fracture (minimally displaced femoral neck fracture) from a low-energy fall. Candidates must be able to undergo surgery and give informed consent themselves or through a proxy. Surgeons performing the operation should be skilled in both arthroplasty and internal fixation techniques.

What is being tested?

The trial is testing two surgical treatments for hip fractures: hip arthroplasty (replacing part or all of the hip joint) versus internal fixation (stabilizing the bone with hardware). Participants will be randomly assigned to one of these groups and monitored for one year to inform future larger studies.

What are the potential side effects?

While not explicitly listed, common side effects from such surgeries may include pain at the site, risk of infection, blood clots, difficulty walking during recovery, and potential need for revision surgery if complications arise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years old or older.

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I have a confirmed complete break in my hip bone.

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I was injured from a fall while standing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess Protocol Compliance

Feasibility of Participant Enrollment

Feasibility of Treatment Allocation

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ArthroplastyExperimental Treatment1 Intervention

A modern porous-coated press-fit or cemented hip arthroplasty prosthesis will be used at the treating surgeon's discretion. Press-fit implants that have no ingrowth or ongrowth surface will not be permitted. We recommend surgeons consider a total hip arthroplasty for younger active, independent participants; conversely, a hemiarthroplasty is recommended for more frail, lower-demand participants. Similarly, cemented arthroplasty for older adult participants is also recommended. The surgical approach and the use of post-operative hip precautions will be determined by the treating surgeon.

Group II: Internal FixationActive Control1 Intervention

Based on the fracture displacement eligibility criteria, minimal or no reduction is expected during the surgical procedure. However, the treating surgeon will be allowed to perform fracture reduction maneuvers if desired. Fixed angle devices and multiple screws will be permitted. The internal fixation device(s) will be inserted through a small lateral incision. If using multiple cancellous screws, an inverted triangle or similar screw pattern is recommended. Fixed angle devices, such as a sliding hip screw (with or without an anti-rotation screw) or newer multi-screw fixed angle devices will also be permitted. Internal fixation constructs combining cancellous screws and fixed angle devices will be permitted.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Arthroplasty

2013

Completed Phase 4

~30

0 / 3Eligibility criteria met