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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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.

Norway1 site
  • Diakonhjemmet Hospital

    Oslo, 0319

Other trials in Norway

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.

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 groups in NCT06146205
Study groupRoleWhat they receive
Direct lateral approachActive comparatorNot described
Receives: Procedure: Direct lateral approach
Spaire approachExperimentalNot described
Receives: Procedure: SPAIRE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Duration of surgery

    Duration of the operation in minutes

    Measured: 1.st day after surgery

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. Adverse events

    Any adverse events will be recorded during the whole study period

    Measured: 0-24 months

  15. 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.

  1. First posted24 Nov 2023
  2. Study start30 Apr 2024
  3. Primary completion30 Aug 2026 (estimated)
  4. Study completion30 Mar 2028 (estimated)

Resources

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)
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

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.

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