Femoral Neck FracturesHipSTHeRNCT03966716
Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR)
A study testing Arthroplasty and Internal Fixation in people with Femoral Neck Fractures and Undisplaced Fracture, run by Uppsala University at 25 sites in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Femoral Neck Fractures, Undisplaced Fracture
- What is being tested?
- Arthroplasty and Internal Fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 25 sitesSweden
- Study dates
- 16 Sep 2019to 1 Sep 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Undisplaced (Garden I-II) femoral neck fracture (within 72h)
- treated at participating unit
- informed consent
- amenable for both treatment options
Who cannot join
- no informed consent
- pathological or stress fracture
- peri-implant fracture
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
Sweden25 sites, 25 recruiting
- Recruiting
Alingsås Hospital
Alingsås
Mia Jodal
- Recruiting
Borås Hospital
Borås
Per-Erik Johansson
- Recruiting
Falu Hospital
Falun
Daniel Fröjd
- Recruiting
Gävle Hospital
Gävle
Hans-Peter Bögl
- Recruiting
Sahlgrenska university Hospital
Gothenburg
Michael Möller
David Hengst
- Recruiting
Jönköping Hospital
Jönköping
Robert Gustafsson
- Recruiting
Kalmar Hospital
Kalmar
Emil Ohlsén
- Recruiting
Karlskrona Hospital
Karlskrona
Olof Leonardsson
- Recruiting
Kungälv Hospital
Kungälv
Ivan Cvetanovic
- Recruiting
Linköping University Hospital
Linköping
Jörg Schilcher
- Recruiting
Sunderby Hospital
Luleå
Nicole Jessen
- Recruiting
Lycksele Hospital
Lycksele
Algirdas Petrauskas
- Recruiting
Skåne Universitetssjukhus
Malmö
Cecilia Rogmark
- Recruiting
Mora Hospital
Mora
Christoffer Thorsell
- Not yet recruiting
Norrtälje Hospital
Norrtälje
Sarwar Mahmood
- Recruiting
Nyköping Hospital
Nyköping
Magdalena Wellhagen
- Recruiting
Skellefteå Hospital
Skellefteå
Constantinos Papadopoulus
- Recruiting
Skövde Hospital
Skövde
Henrik Ståhl
- Recruiting
Danderyd Hospital
Stockholm
Olof Sköldenberg
- Not yet recruiting
Stockholm South Hospital
Stockholm
Piotr Kasina
- Recruiting
Trollhättan Hospital
Trollhättan
Andreas Sylvan
- Recruiting
Umeå University Hospital
Umeå
Sebastian Mukka, Ass Prof, sebastian.mukka@umu.se
- Recruiting
Uppsala University Hospital
Uppsala, Uppsala County, 75185
Olof Wolf, MD PhD, +46709728284, olof.wolf@akademiska.se
Nils Hailer, MD Prof, +46186119038, nils.hailer@surgsci.uu.se
- Recruiting
Västerås Hospital
Västerås
Gunnar Victorin
- Recruiting
Västervik Hospital
Västervik
Johan Liliequist
About this study
Official title: 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).
Read the 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.
- Conditions
- Femoral Neck Fractures, Undisplaced Fracture
- Being tested
- Arthroplasty, Internal Fixation
- Keywords
- Internal Fixation, Hip Arthroplasty, Reoperation Rate, Mortality, Health Economy, External validity, Adverse events
- 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.
ArthroplastyDevice
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 FixationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Arthroplasty | Experimental | Arthroplasty, hemi or total depending on patient characteristics and surgeon's choice Receives: Device: Arthroplasty |
| Internal Fixation | Active comparator | Internal fixation with 2-3 screws or pins, or sliding hip screw device, depending on each hospital's routine Receives: Device: Internal Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite variable comprising reoperation rate and mortality
Both Death and mortality will be accounted for
Measured: 1 to 2-year post-surgery
Secondary outcomes (4)
Reoperation rate
Minor and major reoperations will be noted
Measured: 2-year post-surgery
Long-term Mortality
All deaths are recorded
Measured: 2-year post-surgery
Short-term Mortality
All deaths are recorded
Measured: 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.
Measured: 1-year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start16 Sep 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Sponsor
- Investigators
- Stergios Lazarinis, Study chair, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966716
- Sponsor's protocol ID
- 2019-00140
- Other IDs
- 2019
- Acronym
- HipSTHeR
- Status last verified
- Nov 2024
- First submitted
- 24 May 2019
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28665454Dolatowski 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.
PubMed 30653043Wolf 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.
PubMed 31964340
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HipSTHeR - a Registerbased Randomized Controlled Trial - Hip Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients.
- ClinicalTrials.gov ID
- NCT03966716
- Acronym / sponsor ID
- HipSTHeR / 2019-00140
- Conditions
- Femoral Neck Fractures, Undisplaced Fracture
- Keywords
- Internal Fixation, Hip Arthroplasty, Reoperation Rate, Mortality, Health Economy, External validity, Adverse events
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 29 May 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroplasty | Experimental | Device: ArthroplastyArthroplasty, hemi or total depending on patient characteristics and surgeon's choice |
| Internal Fixation | Active comparator | Device: Internal FixationInternal fixation with 2-3 screws or pins, or sliding hip screw device, depending on each hospital's routine |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Undisplaced (Garden I-II) femoral neck fracture (within 72h)
- treated at participating unit
- informed consent
- amenable for both treatment options
Key exclusion criteria (3 listed)
- no informed consent
- pathological or stress fracture
- peri-implant fracture
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 |
|---|---|---|
| ArthroplastyPatients with an undisplaced femoral neck fracture receive a hemi or total hip arthroplasty depending on each hospital's routine for patient age and mobility. | Device | Arthroplasty |
| Internal FixationPatients 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. | Device | Internal Fixation |
Primary outcome
Composite variable comprising reoperation rate and mortality
Time frame: 1 to 2-year post-surgery
Both Death and mortality will be accounted for
4 secondary outcomes
Reoperation rate
Time frame: 2-year post-surgery
Long-term Mortality
Time frame: 2-year post-surgery
Short-term Mortality
Time frame: 30 day mortality
Patient reported outcome: SMFA
Time frame: 1-year post surgery
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 3 Dec 2024.
- Background: PubMed 28665454Onativia 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.
- Background: PubMed 30653043Dolatowski 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.
- Derived from this study: PubMed 31964340Wolf 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.
- Individual participant dataSharing planned: No
Related trials for Femoral Neck Fractures
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Active, not recruitingPhase 2
BDSF Vs DHS With Anterotational Screw in Vertical FNF
Evaluation of BDSF in FNF
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruiting
Trochanteric Bursa Repair and Lateral Hip Pain After Hemiarthroplasty for Femoral Neck Fracture
Femoral Neck Fracture
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.
Stergios Lazarinis study chair
Uppsala University Hospital
25 sites in 1 country: 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 and Undisplaced Fracture, run by Uppsala University at 25 sites in Sweden.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Sweden. 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?
Contact Wolf Olof, MD, PhD (+46186111707, olof.wolf@surgsci.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite variable comprising reoperation rate and mortality (time frame: 1 to 2-year post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03966716, which also lists 3 linked publications.
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 3 Dec 2024.