Hip FractureHIFSATNCT06146205
The Hip Fracture Surgical Approach Trial
A study testing Direct lateral approach and SPAIRE in people with Hip Fracture and Femoral Neck Fracture, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial summary
The HIFSAT study will compare the standard direct lateral approach to hemiarthroplasty to a new muscle sparing approach (SPAIRE) in femoral neck fracture patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Fracture, Femoral Neck Fracture
- What is being tested?
- Direct lateral approach and SPAIRE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 476 participants
- Where
- 1 siteNorway
- Study dates
- 30 Apr 2024to 30 Mar 2028
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Femoral neck fracture
- Clinical indication for hemiarthroplasty
- Age over 50 years
Who cannot join
- Previous hip implants in the same hip
- Patients assessed to be in a terminal state with an expected survival of less than 1 week
- Other factors that makes follow-up impossible
Trial locations and contacts
1 site in 1 country.
About this study
The HIFSAT study will compare the standard direct lateral approach to hemiarthroplasty to a new muscle sparing approach (SPAIRE) in femoral neck fracture patients.
Read the detailed description
Femoral neck fractures are mostly treated with a hemiarthroplasty, where the fractured femoral head is replaced with a metal implant. The most common surgical approach to hemiarthroplasty has been the lateral approach, in which the gluteus medius tendon is partially released from the greater trochanter. Hip pain and limping is not uncommon after this approach has been used. A new surgical approach (SPAIRE) has been developed to alleviate this problem, and in this method the surgeon approaches the injured hip joint from posterior, preserving most of the muscles and tendons around the hip. This trial is designed to assess if this new SPAIRE approach leads to better results than the lateral approach in patients with femoral neck fractures.
- Conditions
- Hip Fracture, Femoral Neck Fracture
- Being tested
- Direct lateral approach, SPAIRE
- Keywords
- Fragility fracture, Surgical approach, Hemiarthroplasty, SPAIRE, Direct Lateral Approach, Hip Surgery
- Medical subject headings
- Hip Fractures, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct lateral approachProcedure or surgery
Also called Hardinge approach
The hip joint is approached from laterally, and parts of the gluteus medius tendon is released from the greater trochanter before the hip joint is entered from the anterior side.
SPAIREProcedure or surgery
Also called Muscle-sparing modification of the posterior approach
The hip joint is entered from posterior, and the approach preserves the external rotators of the hip joint.
| Study group | Role | What they receive |
|---|---|---|
| Direct lateral approach | Active comparator | Not described Receives: Procedure: Direct lateral approach |
| Spaire approach | Experimental | Not described Receives: Procedure: SPAIRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score ( HHS)
Harris Hip Score (HHS) is an outcome measure for hip-related symptoms. The score is based on both patient-reported information and clinical examination, and is administered by a qualified health care professional. It covers four domains: Pain, function, absence of deformity and range of motion. The score ranges from 0 (worst) to 100 (best).
Measured: 4 months
Secondary outcomes (15)
Harris Hip Score (HHS)
Harris Hip Score (HHS) is an outcome measure for hip-related symptoms. The score is based on both patient-reported information and clinical examination, and is administered by a qualified health care professional. It covers four domains: Pain, function, presence of deformity and range of motion. The score ranges from 0 (worst) to 100 (best).
Measured: 12 and 24 months
Oxford Hip score
Oxford Hip Score(OHS) is a patient reported outcome measure( PROM), OHS is designed to assess outcome after total hip replacement. It has 6 questions on pain and 6 questions on mobility. 5 categories of answer from worst to best. The range is 0-48.
Measured: 4,12 and 24 months
EuroQol-5d-5l
EuroQol-5d-5l is a descriptive system comprises 5 dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state, and these digits can be converted into a single numerical value reflecting how the health state is according to the preferences of the general population of a country/region.
Measured: 4,12 and 24 months
Trendelenburg test
This is a test to identify weakness in gluteal muscles, that can be seen in patients after hip surgery. Unilateral weakness in the gluteal muscles can for instance because nerve damage, trauma to the muscle or rupture of the tendon. The test will be performed as described by Hardcastle and Wade. The patient will be asked to raise their foot from the ground with 30º of hip flexion. The patient will be instructed to raise the non-stance side of the pelvis as high as possible with the examiner supporting the patient by holding their hands if needed. If the patient is not able to maintain this position for 30 seconds, or not being able to raise the hip of the non-stance side to above the level of the stance-side, the Trendelenburg test is considered positive.
Measured: 4,12 and 24 months
New Mobility Score (NMS)
NMS consists of 3 questions about ambulation indoor, outdoor and the ability to go shopping. Each question has 4 alternative answers yielding 0-3 points, and the maximum score is 9.
Measured: 4,12 and 24 months
Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery is an assessment tool made specific for screening of physical function among older adults. SPPB has 3 different tests: Balance, walking speed and rising from a chair. Scorings range from 0-12, best possible is 12.
Measured: 4, 12, an 24 months
Numerical Pain Rate Scale( NPRS)
Unidimensional measure of pain intensity in adults, describing pain extreme from 0 no pain at all to 10 the worst pain imaginable.
Measured: 4, 12 and 24 months
Duration of surgery
Duration of the operation in minutes
Measured: 1.st day after surgery
Preferred Walking Speed
A four-meter distance is marked on the floor, and the patients are instructed to walk this distance in their normal speed, as if they were walking down a street. The distance is walked twice, and the fastest speed is recorded. The subject can use any walking aids, and this is recorded.
Measured: 4,12 and 24 months
Repeated Chair Stand Test
In the repeated chair stand test the participants are asked to fold their arms across their chest (the armrests shall not be not used) and stand up from the chair 5 times. This is timed by the examiner, and points are given from 0 to 4
Measured: 4,12 and 24 months
Cumulated Ambulation Score
This will be recorded at day 1-3 for all patients. This score assesses the patients' early mobility by evaluating their ability to rise from bed, rise from a chair and walk indoor (walking aids permitted).
Measured: 1-5 days after surgery
Timed up and go test
This test measures the time that the person uses to rise from a chair, walk three meters, turn around and walk back to the chair, and sit down again, turning 180 degrees. The person can use any mobility aids that he/she would normally use. The TUG test is being scored by the total time measured
Measured: 4,12 and 24 months
Use of analgesia during admission
Analgesia during the first calendar day after surgery will be recorded as morphine equivalents according to a calculation table published by the Norwegian Directorate of Health.
Measured: 1. day after surgery
Adverse events
Any adverse events will be recorded during the whole study period
Measured: 0-24 months
Days Alive At Home (DAH)
Days alive and at home will be measured at 4,12 and 24 months. Patients wish to stay most of their lives at home, this measurement will tell us how long they could stay home and if they came home after their hip fracture.
Measured: 4,12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start30 Apr 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, University Hospital, Akershus
- Responsible party
- Sponsor
- Investigators
- Siri Lillegraven, PhD, Study chair, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146205
- Sponsor's protocol ID
- HIFSAT
- Acronym
- HIFSAT
- Status last verified
- Mar 2026
- First submitted
- 8 Nov 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hip Fracture Surgical Approach Trial
- ClinicalTrials.gov ID
- NCT06146205
- Acronym / sponsor ID
- HIFSAT / HIFSAT
- Conditions
- Hip Fracture, Femoral Neck Fracture
- Keywords
- Fragility fracture, Surgical approach, Hemiarthroplasty, SPAIRE, Direct Lateral Approach, Hip Surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 476 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- Oslo University Hospital, University Hospital, Akershus
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 24 Nov 2023 (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.
The HIFSAT study will compare the standard direct lateral approach to hemiarthroplasty to a new muscle sparing approach (SPAIRE) in femoral neck fracture patients.
Detailed description
Femoral neck fractures are mostly treated with a hemiarthroplasty, where the fractured femoral head is replaced with a metal implant. The most common surgical approach to hemiarthroplasty has been the lateral approach, in which the gluteus medius tendon is partially released from the greater trochanter. Hip pain and limping is not uncommon after this approach has been used. A new surgical approach (SPAIRE) has been developed to alleviate this problem, and in this method the surgeon approaches the injured hip joint from posterior, preserving most of the muscles and tendons around the hip. This trial is designed to assess if this new SPAIRE approach leads to better results than the lateral approach in patients with femoral neck fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct lateral approach | Active comparator | Procedure: Direct lateral approach |
| Spaire approach | Experimental | Procedure: SPAIRE |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Femoral neck fracture
- Clinical indication for hemiarthroplasty
- Age over 50 years
Key exclusion criteria (3 listed)
- Previous hip implants in the same hip
- Patients assessed to be in a terminal state with an expected survival of less than 1 week
- Other factors that makes follow-up impossible
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 |
|---|---|---|
| Direct lateral approachAlso: Hardinge approachThe hip joint is approached from laterally, and parts of the gluteus medius tendon is released from the greater trochanter before the hip joint is entered from the anterior side. | Procedure or surgery | Direct lateral approach |
| SPAIREAlso: Muscle-sparing modification of the posterior approachThe hip joint is entered from posterior, and the approach preserves the external rotators of the hip joint. | Procedure or surgery | Spaire approach |
Primary outcome
Harris Hip Score ( HHS)
Time frame: 4 months
Harris Hip Score (HHS) is an outcome measure for hip-related symptoms. The score is based on both patient-reported information and clinical examination, and is administered by a qualified health care professional. It covers four domains: Pain, function, absence of deformity and range of motion. The score ranges from 0 (worst) to 100 (best).
15 secondary outcomes
Harris Hip Score (HHS)
Time frame: 12 and 24 months
Oxford Hip score
Time frame: 4,12 and 24 months
EuroQol-5d-5l
Time frame: 4,12 and 24 months
Trendelenburg test
Time frame: 4,12 and 24 months
New Mobility Score (NMS)
Time frame: 4,12 and 24 months
Short Physical Performance Battery (SPPB)
Time frame: 4, 12, an 24 months
Numerical Pain Rate Scale( NPRS)
Time frame: 4, 12 and 24 months
Duration of surgery
Time frame: 1.st day after surgery
Preferred Walking Speed
Time frame: 4,12 and 24 months
Repeated Chair Stand Test
Time frame: 4,12 and 24 months
Cumulated Ambulation Score
Time frame: 1-5 days after surgery
Timed up and go test
Time frame: 4,12 and 24 months
Use of analgesia during admission
Time frame: 1. day after surgery
Adverse events
Time frame: 0-24 months
Days Alive At Home (DAH)
Time frame: 4,12 and 24 months
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 30 Mar 2026.
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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. This study is not recruiting at the moment.
Siri Lillegraven, PhD study chair
Diakonhjemmet Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct lateral approach and SPAIRE in people with Hip Fracture and Femoral Neck Fracture, run by Diakonhjemmet Hospital at 1 site in Norway.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score ( HHS) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2026.