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NCT Number: NCT03966716

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

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).

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Key information

Conditions

Femoral Neck Fractures Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Undisplaced Fracture Wounds and Injuries

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University Hospital, Uppsala, Uppsala County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroplasty

Device

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.

Internal Fixation

Device

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.

Primary outcomes

  1. Composite variable comprising reoperation rate and mortality

    Time frame: 1 to 2-year post-surgery

    Both Death and mortality will be accounted for

Secondary outcomes

  1. Reoperation rate

    Time frame: 2-year post-surgery

    Minor and major reoperations will be noted

  2. Long-term Mortality

    Time frame: 2-year post-surgery

    All deaths are recorded

  3. Short-term Mortality

    Time frame: 30 day mortality

    All deaths are recorded

  4. 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.

Other outcomes

  1. 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.

  2. Long-term reoperation rate

    Time frame: 5 and 10 years post-surgery

    Minor and major reoperations will be noted

  3. External validity

    Time frame: 2-year post-surgery

    Assessment of eligible patients not included in the study

Study contacts

Contact information is provided by the study sponsor or research team.

Wolf Olof, MD, PhD

CONTACT

[email protected]

+46186111707

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • The Swedish Research Council

Registry information

Official study title

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

Acronym: HipSTHeR

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
May 29, 2019
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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