Femoral Neck FracturesNCT05947058
Minimally Displaced Femoral Neck Fracture Pilot Study
A study testing Arthroplasty and Internal Fixation in people with Femoral Neck Fractures, run by University of Maryland, Baltimore at 12 sites in 3 countries.
Trial summary
The goal of this randomized pilot study is to assess feasibility of the trial and to collect information to inform the design of a definitive trial. Adult patients ages 60 years or older with a low-energy minimally displaced femoral neck fracture (FNF) treated with surgery will be eligible to participate in the study. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Arthroplasty and Internal Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 1 Nov 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Minimally displaced fracture that could be, in the judgment of the attending surgeon, optimally managed with either arthroplasty or in situ internal fixation without reduction.
- Low energy injury mechanism defined as a fall from standing height.
- Informed consent obtained from patient or proxy.
- Surgeons with expertise in total hip arthroplasty, hemiarthroplasty, and internal fixation are available to perform surgery. Note: Surgeons do not need to be experts in all techniques.
Who cannot join
- Unable to ambulate 10 feet pre-injury with any assistance.
- Associated lower extremity injury that prevents post-operative weightbearing.
- Retained hardware around the hip that precludes either study treatment.
- Infection around the hip (soft tissue or bone).
- Pathologic fracture with a lytic lesion in the femoral neck that precludes internal fixation.
- Patient is too ill, in the judgement of the attending surgeon, for internal fixation.
Show all 12Show fewer
- Patient is too ill, in the judgement of the attending surgeon, for arthroplasty.
- Unable to obtain informed consent due to language barriers.
- Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- Currently enrolled in a study that does not permit co-enrollment.
- Prior enrollment in the trial.
- Other reason to exclude the patient, as approved by the Methods Centre.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States8 sites
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
University of Florida
Gainesville, Florida, 32611
University of Maryland Capital Region Health
Largo, Maryland, 20774
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Southern California
Los Angeles, California, 90007
Yale University
New Haven, Connecticut, 06520
Canada3 sites
Hamilton Health Sciences
Hamilton, Ontario, L8V 1C3
London Health Sciences Centre
London, Ontario, N6A 5W9
University of British Columbia
Vancouver, British Columbia, V6T 1Z2
About this study
Official title: Multicenter Randomized Controlled Trial Comparing Hip Arthroplasty to Internal Fixation for Minimally Displaced Femoral Neck Fractures: A Pilot Study
The goal of this randomized pilot study is to assess feasibility of the trial and to collect information to inform the design of a definitive trial. Adult patients ages 60 years or older with a low-energy minimally displaced femoral neck fracture (FNF) treated with surgery will be eligible to participate in the study. Patients will be randomized to one of two treatment groups, hip arthroplasty or internal fixation. Participants will be followed for 1 year.
Read the detailed description
Nearly half of all elderly hip fractures are femoral neck fractures (FNFs) and approximately 20% are minimally displaced. Internal fixation has remained the treatment of choice for these injuries because these fractures can be fixed in situ and the surgical implants can be inserted with little surgical dissection. Patients treated with internal fixation experience high complication rates, with the pooled risk of reoperation and mortality each above 14%. Preliminary data have suggested arthroplasty for minimally displaced fractures may lead to better patient outcomes, including improved ambulation, fewer reoperations, and a lower risk of death compared to internal fixation. While the preliminary data supporting the use of arthroplasty for minimally displaced fractures is promising, the necessary evidence to make this significant practice change remains lacking.
The eventual definitive trial has significant potential to change clinical practice and optimize patient outcomes for individuals that experience a minimally displaced FNF. Treating minimally displaced FNFs with arthroplasty, instead of internal fixation, would be a paradigm shift in clinical care. This pilot study will demonstrate feasibility of the definitive trial and be used to refine aspects of the study protocol as necessary. If feasibility is successfully demonstrated, the pilot activities will be considered a vanguard phase for the definitive clinical trial.
Adult patients ages 60 years or older with a low-energy minimally displaced femoral neck fracture treated with surgery will be eligible to participate in the study. Patients will be randomized to receive either hip arthroplasty or internal fixation. Patients will be followed for 1 year, with visits occurring at 6 weeks, 4 months, 8 months, and 1 year after fracture. At each follow-up, mortality, ambulation, days at home, and health status will be collected.
The primary objective is to assess feasibility of the trial and to collect information to inform the design of the definitive trial. The feasibility outcomes will include participant enrollment, adherence to treatment allocation, data collection methods, and compliance with key aspects of the protocol.
- Conditions
- Femoral Neck Fractures
- Being tested
- Arthroplasty, Internal Fixation
- Keywords
- Minimally Displaced Femoral Neck Fractures, Arthroplasty, Internal Fixation
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthroplastyProcedure or surgery
The type of hip prothesis (hemi or total; cemented or uncemented) will be at the discretion of the treating surgeon.
Internal FixationProcedure or surgery
Both fixed angle devices and multiple screws will be permitted for the internal fixation group.
| Study group | Role | What they receive |
|---|---|---|
| Arthroplasty | Experimental | 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. Receives: Procedure: Arthroplasty |
| Internal Fixation | Active comparator | 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. Receives: Procedure: Internal Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Participant Enrollment
Participant enrollment will be assessed by monitoring screening and enrollment metrics, including:
- Proportion of clinical sites initiated and able to screen consecutive patients with minimally displaced FNF
- Proportion of patients who are screened for eligibility to participate in the trial
- Proportion of patients who meet the eligibility criteria
- Proportion of patients who provide informed consent
- Proportion of time required to enroll at least four participants per clinical site
- Proportion of reasons for exclusion.
Measured: 12 months
Feasibility of Treatment Allocation
Feasibility of the treatment allocation will be assessed using the following metrics:
- Adherence to arthroplasty treatment allocation
- Adherence to internal fixation treatment allocation
Measured: 12 months
Refine Data Collection Methods
To refine the data collection methods, the following metrics will be reviewed:
- Proportion of participants with missing data
- Review of missing data to identify data fields that are not feasible to collect
- Data errors to identify ways to improve the flow of the case report forms (CRFs) and data collection
Measured: 12 months
Assess Protocol Compliance
The following metrics will be used to assess compliance with the protocol:
- Proportion of randomization errors
- Proportion of participants who complete each follow-up visit
- Proportion of participants who withdraw from the trial (withdrawal of consent)
- Proportion of participants who cannot be located (loss to follow-up)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association, McMaster University, University of Southern California, University of California, Irvine
- Responsible party
- Principal investigator, Mark Gage, University of Maryland, Baltimore
- Investigators
- Gerard Slobogean, MD, Principal investigator, University of Maryland, BaltimoreSheila Sprague, PhD, Principal investigator, McMaster UniversityJoseph Patterson, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947058
- Sponsor's protocol ID
- HP-00100917
- Status last verified
- Feb 2026
- First submitted
- 2 Jun 2023
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial Comparing Hip Arthroplasty to Internal Fixation for Minimally Displaced Femoral Neck Fractures: A Pilot Study
- ClinicalTrials.gov ID
- NCT05947058
- Acronym / sponsor ID
- HP-00100917
- Conditions
- Femoral Neck Fractures
- Keywords
- Minimally Displaced Femoral Neck Fractures, Arthroplasty, Internal Fixation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association, McMaster University, University of Southern California, University of California, Irvine
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized pilot study is to assess feasibility of the trial and to collect information to inform the design of a definitive trial. Adult patients ages 60 years or older with a low-energy minimally displaced femoral neck fracture (FNF) treated with surgery will be eligible to participate in the study. Patients will be randomized to one of two treatment groups, hip arthroplasty or internal fixation. Participants will be followed for 1 year.
Detailed description
Nearly half of all elderly hip fractures are femoral neck fractures (FNFs) and approximately 20% are minimally displaced. Internal fixation has remained the treatment of choice for these injuries because these fractures can be fixed in situ and the surgical implants can be inserted with little surgical dissection. Patients treated with internal fixation experience high complication rates, with the pooled risk of reoperation and mortality each above 14%. Preliminary data have suggested arthroplasty for minimally displaced fractures may lead to better patient outcomes, including improved ambulation, fewer reoperations, and a lower risk of death compared to internal fixation. While the preliminary data supporting the use of arthroplasty for minimally displaced fractures is promising, the necessary evidence to make this significant practice change remains lacking.
The eventual definitive trial has significant potential to change clinical practice and optimize patient outcomes for individuals that experience a minimally displaced FNF. Treating minimally displaced FNFs with arthroplasty, instead of internal fixation, would be a paradigm shift in clinical care. This pilot study will demonstrate feasibility of the definitive trial and be used to refine aspects of the study protocol as necessary. If feasibility is successfully demonstrated, the pilot activities will be considered a vanguard phase for the definitive clinical trial.
Adult patients ages 60 years or older with a low-energy minimally displaced femoral neck fracture treated with surgery will be eligible to participate in the study. Patients will be randomized to receive either hip arthroplasty or internal fixation. Patients will be followed for 1 year, with visits occurring at 6 weeks, 4 months, 8 months, and 1 year after fracture. At each follow-up, mortality, ambulation, days at home, and health status will be collected.
The primary objective is to assess feasibility of the trial and to collect information to inform the design of the definitive trial. The feasibility outcomes will include participant enrollment, adherence to treatment allocation, data collection methods, and compliance with key aspects of the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroplasty | Experimental | Procedure: ArthroplastyA 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. |
| Internal Fixation | Active comparator | Procedure: Internal FixationBased 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
- Minimally displaced fracture that could be, in the judgment of the attending surgeon, optimally managed with either arthroplasty or in situ internal fixation without reduction.
- Low energy injury mechanism defined as a fall from standing height.
- Informed consent obtained from patient or proxy.
Key exclusion criteria (12 listed)
- Unable to ambulate 10 feet pre-injury with any assistance.
- Associated lower extremity injury that prevents post-operative weightbearing.
- Retained hardware around the hip that precludes either study treatment.
- Infection around the hip (soft tissue or bone).
- Pathologic fracture with a lytic lesion in the femoral neck that precludes internal fixation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArthroplastyThe type of hip prothesis (hemi or total; cemented or uncemented) will be at the discretion of the treating surgeon. | Procedure or surgery | Arthroplasty |
| Internal FixationBoth fixed angle devices and multiple screws will be permitted for the internal fixation group. | Procedure or surgery | Internal Fixation |
Primary outcome
Feasibility of Participant Enrollment
Time frame: 12 months
Participant enrollment will be assessed by monitoring screening and enrollment metrics, including: * Proportion of clinical sites initiated and able to screen consecutive patients with minimally displaced FNF * Proportion of patients who are screened for eligibility to participate in the trial * Proportion of patients who meet the eligibility criteria * Proportion of patients who provide informed consent * Proportion of time required to enroll at least four participants per clinical site * Proportion of reasons for exclusion.
Feasibility of Treatment Allocation
Time frame: 12 months
Feasibility of the treatment allocation will be assessed using the following metrics: * Adherence to arthroplasty treatment allocation * Adherence to internal fixation treatment allocation
Refine Data Collection Methods
Time frame: 12 months
To refine the data collection methods, the following metrics will be reviewed: * Proportion of participants with missing data * Review of missing data to identify data fields that are not feasible to collect * Data errors to identify ways to improve the flow of the case report forms (CRFs) and data collection
Assess Protocol Compliance
Time frame: 12 months
The following metrics will be used to assess compliance with the protocol: * Proportion of randomization errors * Proportion of participants who complete each follow-up visit * Proportion of participants who withdraw from the trial (withdrawal of consent) * Proportion of participants who cannot be located (loss to follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Slobogean, MD principal investigator
University of Maryland, Baltimore
Sheila Sprague, PhD principal investigator
McMaster University
Joseph Patterson, MD principal investigator
University of Southern California
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroplasty and Internal Fixation in people with Femoral Neck Fractures, run by University of Maryland, Baltimore at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Participant Enrollment (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.