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

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: Recruiting
• Conditions: Femoral Neck Fractures; Undisplaced Fracture
• Intervention / Treatment: Device: Arthroplasty; Device: Internal Fixation

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: Interventional
• Enrollment (Estimated): 1440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wolf Olof, MD, PhD; Phone Number: +46186111707; Email: olof.wolf@surgsci.uu.se

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
    • Recruiting
    • Umea University Hospital
    • Contact: Sebastian Mukka, Ass Prof; Email: sebastian.mukka@umu.se
  • Västervik, Sweden
    • Recruiting
    • Västervik Hospital
    • Contact: Johan Liliequist
  • Västerås, Sweden
    • Recruiting
    • Västerås Hospital
    • Contact: Gunnar Victorin
  • Uppsala Lan
    • Uppsala, Uppsala Lan, Sweden, 75185
      • Recruiting
      • Uppsala University Hospital
      • Contact: Olof Wolf, MD PhD; Phone Number: +46709728284; Email: olof.wolf@akademiska.se
      • Contact: Nils Hailer, MD Prof; Phone Number: +46186119038; Email: nils.hailer@surgsci.uu.se

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Composite variable comprising reoperation rate and mortality	Both Death and mortality will be accounted for	1 to 2-year post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation rate	Minor and major reoperations will be noted	2-year post-surgery
Long-term Mortality	All deaths are recorded	2-year post-surgery
Short-term Mortality	All deaths are recorded	30 day mortality
Patient reported outcome: SMFA	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

Outcome Measure	Measure Description	Time Frame
Occurrence of adverse events.	Adverse events, such as pulmonary embolism, infection, dislocation, myocardial infarction and stroke will be noted.	1-year post-surgery
Long-term reoperation rate	Minor and major reoperations will be noted	5 and 10 years post-surgery
External validity	Assessment of eligible patients not included in the study	2-year post-surgery

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: The Swedish Research Council
• Investigators: Study Chair: Stergios Lazarinis, Uppsala University Hospital

Publications and helpful links

General Publications

• Dolatowski FC, Frihagen F, Bartels S, Opland V, Saltyte Benth J, Talsnes O, Hoelsbrekken SE, Utvag SE. Screw Fixation Versus Hemiarthroplasty for Nondisplaced Femoral Neck Fractures in Elderly Patients: A Multicenter Randomized Controlled Trial. J Bone Joint Surg Am. 2019 Jan 16;101(2):136-144. doi: 10.2106/JBJS.18.00316.
• Wolf O, Sjoholm P, Hailer NP, Moller M, Mukka S. Study protocol: HipSTHeR - a register-based randomised controlled trial - hip screws or (total) hip replacement for undisplaced femoral neck fractures in older patients. BMC Geriatr. 2020 Jan 21;20(1):19. doi: 10.1186/s12877-020-1418-2.
• Onativia IJ, Slullitel PA, Diaz Dilernia F, Gonzales Viezcas JM, Vietto V, Ramkumar PN, Buttaro MA, Piuzzi NS. Outcomes of nondisplaced intracapsular femoral neck fractures with internal screw fixation in elderly patients: a systematic review. Hip Int. 2018 Jan;28(1):18-28. doi: 10.5301/hipint.5000532. Erratum In: Hip Int. 2020 Mar;30(2):NP1. doi: 10.1177/1120700018804318.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Mortality; Hip Arthroplasty; Adverse events; Internal Fixation; Reoperation Rate; Health Economy; External validity
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID 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