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

Primary Purpose

Femoral Neck Fractures, Undisplaced Fracture

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Arthroplasty
Internal Fixation
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring Internal Fixation, Hip Arthroplasty, Reoperation Rate, Mortality, Health Economy, External validity, Adverse events

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uppsala University HospitalRecruiting
  • Alingsås HospitalRecruiting
  • Borås HospitalRecruiting
  • Falu HospitalRecruiting
  • Sahlgrenska university HospitalRecruiting
  • Gävle HospitalRecruiting
  • Jönköping HospitalRecruiting
  • Kalmar HospitalRecruiting
  • Karlskrona HospitalRecruiting
  • Kungälv HospitalRecruiting
  • Linköping University HospitalRecruiting
  • Sunderby HospitalRecruiting
  • Lycksele HospitalRecruiting
  • Skåne UniversitetssjukhusRecruiting
  • Mora HospitalRecruiting
  • Norrtälje Hospital
  • Nyköping HospitalRecruiting
  • Skellefteå HospitalRecruiting
  • Skövde HospitalRecruiting
  • Danderyd HospitalRecruiting
  • Stockholm South Hospital
  • Trollhättan HospitalRecruiting
  • Umeå University HospitalRecruiting
  • Västervik HospitalRecruiting
  • Västerås HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arthroplasty

Internal Fixation

Arm Description

Arthroplasty, hemi or total depending on patient characteristics and surgeon's choice

Internal fixation with 2-3 screws or pins, or sliding hip screw device, depending on each hospital's routine

Outcomes

Primary Outcome Measures

Composite variable comprising reoperation rate and mortality
Both Death and mortality will be accounted for

Secondary Outcome Measures

Reoperation rate
Minor and major reoperations will be noted
Long-term Mortality
All deaths are recorded
Short-term Mortality
All deaths are recorded
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.

Full Information

First Posted
May 24, 2019
Last Updated
June 26, 2023
Sponsor
Uppsala University
Collaborators
The Swedish Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT03966716
Brief Title
Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR)
Acronym
HipSTHeR
Official Title
HipSTHeR - a Registerbased Randomized Controlled Trial - Hip Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
The Swedish Research Council

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures, Undisplaced Fracture
Keywords
Internal Fixation, Hip Arthroplasty, Reoperation Rate, Mortality, Health Economy, External validity, Adverse events

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arthroplasty
Arm Type
Experimental
Arm Description
Arthroplasty, hemi or total depending on patient characteristics and surgeon's choice
Arm Title
Internal Fixation
Arm Type
Active Comparator
Arm Description
Internal fixation with 2-3 screws or pins, or sliding hip screw device, depending on each hospital's routine
Intervention Type
Device
Intervention Name(s)
Arthroplasty
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Internal Fixation
Intervention Description
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 Outcome Measure Information:
Title
Composite variable comprising reoperation rate and mortality
Description
Both Death and mortality will be accounted for
Time Frame
1 to 2-year post-surgery
Secondary Outcome Measure Information:
Title
Reoperation rate
Description
Minor and major reoperations will be noted
Time Frame
2-year post-surgery
Title
Long-term Mortality
Description
All deaths are recorded
Time Frame
2-year post-surgery
Title
Short-term Mortality
Description
All deaths are recorded
Time Frame
30 day mortality
Title
Patient reported outcome: SMFA
Description
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.
Time Frame
1-year post surgery
Other Pre-specified Outcome Measures:
Title
Occurrence of adverse events.
Description
Adverse events, such as pulmonary embolism, infection, dislocation, myocardial infarction and stroke will be noted.
Time Frame
1-year post-surgery
Title
Long-term reoperation rate
Description
Minor and major reoperations will be noted
Time Frame
5 and 10 years post-surgery
Title
External validity
Description
Assessment of eligible patients not included in the study
Time Frame
2-year post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wolf Olof, MD, PhD
Phone
+46186111707
Email
olof.wolf@surgsci.uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stergios Lazarinis
Organizational Affiliation
Uppsala University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
State/Province
Uppsala Lan
ZIP/Postal Code
75185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olof Wolf, MD PhD
Phone
+46709728284
Email
olof.wolf@akademiska.se
First Name & Middle Initial & Last Name & Degree
Nils Hailer, MD Prof
Phone
+46186119038
Email
nils.hailer@surgsci.uu.se
Facility Name
Alingsås Hospital
City
Alingsås
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mia Jodal
Facility Name
Borås Hospital
City
Borås
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per-Erik Johansson
Facility Name
Falu Hospital
City
Falun
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Fröjd
Facility Name
Sahlgrenska university Hospital
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Möller
First Name & Middle Initial & Last Name & Degree
David Hengst
Facility Name
Gävle Hospital
City
Gävle
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans-Peter Bögl
Facility Name
Jönköping Hospital
City
Jönköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Gustafsson
Facility Name
Kalmar Hospital
City
Kalmar
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emil Ohlsén
Facility Name
Karlskrona Hospital
City
Karlskrona
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olof Leonardsson
Facility Name
Kungälv Hospital
City
Kungälv
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Cvetanovic
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jörg Schilcher
Facility Name
Sunderby Hospital
City
Luleå
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Jessen
Facility Name
Lycksele Hospital
City
Lycksele
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Algirdas Petrauskas
Facility Name
Skåne Universitetssjukhus
City
Malmö
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilia Rogmark
Facility Name
Mora Hospital
City
Mora
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoffer Thorsell
Facility Name
Norrtälje Hospital
City
Norrtälje
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarwar Mahmood
Facility Name
Nyköping Hospital
City
Nyköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena Wellhagen
Facility Name
Skellefteå Hospital
City
Skellefteå
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Constantinos Papadopoulus
Facility Name
Skövde Hospital
City
Skövde
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Ståhl
Facility Name
Danderyd Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olof Sköldenberg
Facility Name
Stockholm South Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Kasina
Facility Name
Trollhättan Hospital
City
Trollhättan
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Sylvan
Facility Name
Umeå University Hospital
City
Umeå
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Mukka, Ass Prof
Email
sebastian.mukka@umu.se
Facility Name
Västervik Hospital
City
Västervik
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Liliequist
Facility Name
Västerås Hospital
City
Västerås
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gunnar Victorin

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28665454
Citation
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.
Results Reference
background
PubMed Identifier
30653043
Citation
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.
Results Reference
background
PubMed Identifier
31964340
Citation
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.
Results Reference
derived

Learn more about this trial

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

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