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Procedure

Hip Surgery Options for Femoral Neck Fracture

N/A

Recruiting

Led By Sheila Sprague, PhD

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess Protocol Compliance

Feasibility of Participant Enrollment

Feasibility of Treatment Allocation

+1 more

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

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaOTHER

906 Previous Clinical Trials

1,596,136 Total Patients Enrolled

McMaster UniversityOTHER

884 Previous Clinical Trials

2,598,276 Total Patients Enrolled

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,616 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for individuals participating in this research?

"Affirmative. According to records hosted on clinicaltrials.gov, this research project is still seeking participants. It was first published on November 1st 2023 and the information has been revised as recently as November 28th 2023. The trial necessitates 40 patients from a single medical centre."

Answered by AI

Are there any slots still available for those interested in participating in this clinical trial?

"The clinical trial is currently recruiting as indicated on the online database, clinicaltrials.gov. It was originally posted on November 1st 2023 and was recently updated on the 28th of that same month."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Minimally Displaced Femoral Neck Fracture Pilot Study

Gerard Slobogean 2023. "Minimally Displaced Femoral Neck Fracture Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05947058.