Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR) (HipSTHeR)

November 28, 2024 updated by: Uppsala University

HipSTHeR - a Registerbased Randomized Controlled Trial - Hip Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients.

A registerbased RCT will investigate whether arthroplasty can decrease the reoperation rate compared to internal fixation for patients with an undisplaced femoral neck fracture (Garden I-II).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this study is to determine whether the treatment of elderly patients with an undisplaced femoral neck fracture (uFNF) can be improved by decreasing reoperation rates through replacing the hip instead of trying to preserve it. Patients ≥75 years with an uFNF will be included and randomized within the Swedish Fracture Register (SFR) platform to internal fixation (screws/pins) or arthroplasty (choice of hemi or total is at the surgeon's discretion). The primary outcome will be a composite variable that combines two variables (reoperations and mortality) into a single variable.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1440

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Alingsås, Sweden
        • Recruiting
        • Alingsås Hospital
        • Contact:
          • Mia Jodal
      • Borås, Sweden
        • Recruiting
        • Borås Hospital
        • Contact:
          • Per-Erik Johansson
      • Falun, Sweden
        • Recruiting
        • Falu Hospital
        • Contact:
          • Daniel Fröjd
      • Gothenburg, Sweden
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:
          • Michael Möller
        • Contact:
          • David Hengst
      • Gävle, Sweden
        • Recruiting
        • Gävle Hospital
        • Contact:
          • Hans-Peter Bögl
      • Jönköping, Sweden
        • Recruiting
        • Jönköping Hospital
        • Contact:
          • Robert Gustafsson
      • Kalmar, Sweden
        • Recruiting
        • Kalmar Hospital
        • Contact:
          • Emil Ohlsén
      • Karlskrona, Sweden
        • Recruiting
        • Karlskrona Hospital
        • Contact:
          • Olof Leonardsson
      • Kungälv, Sweden
        • Recruiting
        • Kungälv Hospital
        • Contact:
          • Ivan Cvetanovic
      • Linköping, Sweden
        • Recruiting
        • Linköping University Hospital
        • Contact:
          • Jörg Schilcher
      • Luleå, Sweden
        • Recruiting
        • Sunderby Hospital
        • Contact:
          • Nicole Jessen
      • Lycksele, Sweden
        • Recruiting
        • Lycksele Hospital
        • Contact:
          • Algirdas Petrauskas
      • Malmö, Sweden
        • Recruiting
        • Skåne Universitetssjukhus
        • Contact:
          • Cecilia Rogmark
      • Mora, Sweden
        • Recruiting
        • Mora Hospital
        • Contact:
          • Christoffer Thorsell
      • Norrtälje, Sweden
        • Not yet recruiting
        • Norrtälje Hospital
        • Contact:
          • Sarwar Mahmood
      • Nyköping, Sweden
        • Recruiting
        • Nyköping Hospital
        • Contact:
          • Magdalena Wellhagen
      • Skellefteå, Sweden
        • Recruiting
        • Skellefteå Hospital
        • Contact:
          • Constantinos Papadopoulus
      • Skövde, Sweden
        • Recruiting
        • Skövde Hospital
        • Contact:
          • Henrik Ståhl
      • Stockholm, Sweden
        • Recruiting
        • Danderyd Hospital
        • Contact:
          • Olof Sköldenberg
      • Stockholm, Sweden
        • Not yet recruiting
        • Stockholm South Hospital
        • Contact:
          • Piotr Kasina
      • Trollhättan, Sweden
        • Recruiting
        • Trollhättan Hospital
        • Contact:
          • Andreas Sylvan
      • Umeå, Sweden
      • Västervik, Sweden
        • Recruiting
        • Västervik Hospital
        • Contact:
          • Johan Liliequist
      • Västerås, Sweden
        • Recruiting
        • Västerås Hospital
        • Contact:
          • Gunnar Victorin
    • Uppsala Lan
      • Uppsala, Uppsala Lan, Sweden, 75185

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Undisplaced (Garden I-II) femoral neck fracture (within 72h)
  • treated at participating unit
  • informed consent
  • amenable for both treatment options

Exclusion Criteria:

  • no informed consent
  • pathological or stress fracture
  • peri-implant fracture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arthroplasty
Arthroplasty, hemi or total depending on patient characteristics and surgeon's choice
Device: Arthroplasty
Patients with an undisplaced femoral neck fracture receive a hemi or total hip arthroplasty depending on each hospital's routine for patient age and mobility.
Active Comparator: Internal Fixation
Internal fixation with 2-3 screws or pins, or sliding hip screw device, depending on each hospital's routine
Device: Internal Fixation
Patients with an undisplaced femoral neck fracture undergo a closed reduction and internal fixation with 2-3 screws or pins, or sliding hip screw device. Type of fixation depends on each hospital's routine.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite variable comprising reoperation rate and mortality
Time Frame: 1 to 2-year post-surgery
Both Death and mortality will be accounted for
1 to 2-year post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reoperation rate
Time Frame: 2-year post-surgery
Minor and major reoperations will be noted
2-year post-surgery
Long-term Mortality
Time Frame: 2-year post-surgery
All deaths are recorded
2-year post-surgery
Short-term Mortality
Time Frame: 30 day mortality
All deaths are recorded
30 day mortality
Patient reported outcome: SMFA
Time Frame: 1-year post surgery
Short Musculoskeletal Functional Assessment (SMFA) questionnaire, will be routinely collected within the Swedish Fracture Register 1 year after the injury and compared with the results obtained by recall technique at the time of the fracture.
1-year post surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence of adverse events.
Time Frame: 1-year post-surgery
Adverse events, such as pulmonary embolism, infection, dislocation, myocardial infarction and stroke will be noted.
1-year post-surgery
Long-term reoperation rate
Time Frame: 5 and 10 years post-surgery
Minor and major reoperations will be noted
5 and 10 years post-surgery
External validity
Time Frame: 2-year post-surgery
Assessment of eligible patients not included in the study
2-year post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uppsala University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Swedish Research Council

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Stergios Lazarinis, Uppsala University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-00140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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