Femoral Neck FracturesNCT04900506
Surgical Approach in Hemiarthroplasty. A Randomized Clinical Trial Comparing Posterior and Anterior Approach
A study testing Posterior SPAIRE approach, anterior approach in people with Femoral Neck Fractures and Bone Mineral Density, run by Sorlandet Hospital HF at 2 sites in Norway.
Trial summary
Dislocated femoral neck fractures are routinely treated with cemented hemiartroplasty and the direct lateral approach (Hardinge) has commonly been used in Norway. The investigators have lately witnessed a significant change in the prefered surgical approaches in total hip arthroplasty (THA) in favor of the posterior… Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Femoral Neck Fractures, Bone Mineral Density, Muscle Damage
- What is being tested?
- Posterior SPAIRE approach, anterior approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesNorway
- Study dates
- 21 Jan 2022to 10 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 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients between 70 and 90 years of age
- Displaced FNF
- Ability to walk with or without a walking aid prior to falling
- Patients having Sorlandet Hospital as primary service provider for orthopaedic trauma
- Provision of informed consent by patient or proxy
- Low energy fracture (fall from standing height, no other major trauma)
Who cannot join
- Dementia
- Fractures in pathologic bone
- Patients not suited for HA (i.e., inflammatory arthritis, severe osteoarthritis)
- Associated major injuries of the lower extremity ( i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula or femur)
- Retained hardware around the affected hip that will interfere with arthroplasty
- Sepsis or local infection
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Cemented Hemiarthroplasty in Femoral Neck Fractures; Are Clinical Results Affected by Surgical Approach. A Randomized Clinical Trial Comparing Posterior and Anterior Approach
Dislocated femoral neck fractures are routinely treated with cemented hemiartroplasty and the direct lateral approach (Hardinge) has commonly been used in Norway. The investigators have lately witnessed a significant change in the prefered surgical approaches in total hip arthroplasty (THA) in favor of the posterior and anterior approaches. The direct lateral approach has in THA, more or less, been abandoned in Norway. Numerous studies have reported superior results using the posterior and anterior approahes compared to the lateral approach.
Read the detailed description
The investigators have witnessed a marked change in preferred anatomical route to the hip joint when performing total hip artrhroplasty (THA) for osteoarthritis in Norway. The direct lateral approach, which 10 years ago dominated, is today more or less abandoned. Several studies have reported inferior results in patients operated with the lateral approach compared to the posterior and anterior approaches, the latter approaches used in approximately 95 % of all THA´s i Norway. Many approaches are known for hip arthroplasty in trauma patients, but there is little consensus on the preferred method. The preferred surgical approach varies among hospitals and surgeons. Identifying the best possible approach for HA could lead to shorter hospital admission, faster rehabilitation, better functional outcomes, lower morbidity and mortality and improvement in patient independence. Consequently healthcare costs related to a hip fracture could be reduced.
As of today the clinical results, reoperation rate and the morbidity have improved significantly in hemiarthroplasty treatment for dislocated femoral neck fractures. However, patients are primarily operated with the lateral approach, although inferior results are reported compared to posterior and anterior approaches. RCT´s from Ugland et al and Mjaaland have shown increased incidence of limping, lateral thigh pain and inferior PROM´s in patients operated with the direct lateral approach compared to patients operated with anterior approaches.
A meta-analysis regarding hemiarthroplasty and surgical approaches from 2018 concluded that high-quality comparative studies are needed to further substantiate the preferred anatomic route for hemiarthroplasty in older femoral neck fracture patients.
- Being tested
- Posterior SPAIRE approach, anterior approach
- 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.
Posterior SPAIRE approach, anterior approachProcedure or surgery
Also called Bone Mineral Density, Biochemical muscle damage, Clinical muscle damage
Based on power calculation a sub-group analysis of 50 patients will be examined with DXA, all patients for biochemical and clinical muscle damage (CK, CRP, TUG-test, Trendelenburg, strenght test)
| Study group | Role | What they receive |
|---|---|---|
| cemented hemiarthroplasty , posterior SPAIRE approach | Active comparator | Posterior SPAIRE approach: lateral decubitus position, preservation of the piriformis tendon and obturator internus, detatchment of obturator externus , capsular T-incision, femoral neck resection, femoral canal reaming according to preoperative templating, third generation cementation technique, capsular repair, repair of obturator externus. Receives: Procedure: Posterior SPAIRE approach, anterior approach |
| cemented hemiarthroplasty, anterior approach | Active comparator | Anterior approach: supine position, both legs washed and draped, intermuscular plane between m. tensor fascia lata and m. sartorius, capsular T-incision, femoral neck resection, femoral canal reaming according to preoperative templating, third generation cementation technique, capsular repair Receives: Procedure: Posterior SPAIRE approach, anterior approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent patient reported outcome measured by Harris Hip Score.
Measured: 2 years
Secondary outcomes (9)
Bone Mineral Density
The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent postoperative changes in bone mineral density measured by dual-energy X-ray absorptiometry (DXA).
Measured: 2 years
Muscle damage
The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent postoperative changes in biochemical muscle damage measured by Creatin Kinase (CK)
Measured: 2 years
Muscle damage
The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent postoperative changes in clinical muscle damage measured by TUG-test
Measured: 2 years
Muscle damage
The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent postoperative changes in clinical muscle damage measured by Trendelenburg test
Measured: 2 years
Muscle damage
The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent postoperative changes in clinical muscle damage measured by muscle strength
Measured: 2 years
Health-related quality of life (HRQoL)
The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent health-related quality of life (HRQoL) measured by HOOS
Measured: 2 years
Health-related quality of life (HRQoL)
The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent health-related quality of life (HRQoL) measured by Eq-5d
Measured: 2 years
Health-related quality of life (HRQoL)
The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent health-related quality of life (HRQoL) measured by Visual Analog Score (VAS)
Measured: 2 years
Radiographic stem positioning
The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent radiographic stem positioning.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start21 Jan 2022
- Primary completion10 Jun 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies 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
- Model description
- Patients are allocated to either an anterior approach or a posterior approach after inclusion. Both groups are operated with a cemented hemiarthroplasty
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Sponsor
- Investigators
- Lars Nordsletten, MD,PhD,Professor, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900506
- Sponsor's protocol ID
- Sorlandet HF
- Status last verified
- May 2026
- First submitted
- 5 May 2021
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cemented Hemiarthroplasty in Femoral Neck Fractures; Are Clinical Results Affected by Surgical Approach. A Randomized Clinical Trial Comparing Posterior and Anterior Approach
- ClinicalTrials.gov ID
- NCT04900506
- Acronym / sponsor ID
- Sorlandet HF
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 25 May 2021 (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.
Dislocated femoral neck fractures are routinely treated with cemented hemiartroplasty and the direct lateral approach (Hardinge) has commonly been used in Norway. The investigators have lately witnessed a significant change in the prefered surgical approaches in total hip arthroplasty (THA) in favor of the posterior and anterior approaches. The direct lateral approach has in THA, more or less, been abandoned in Norway. Numerous studies have reported superior results using the posterior and anterior approahes compared to the lateral approach.
Detailed description
The investigators have witnessed a marked change in preferred anatomical route to the hip joint when performing total hip artrhroplasty (THA) for osteoarthritis in Norway. The direct lateral approach, which 10 years ago dominated, is today more or less abandoned. Several studies have reported inferior results in patients operated with the lateral approach compared to the posterior and anterior approaches, the latter approaches used in approximately 95 % of all THA´s i Norway. Many approaches are known for hip arthroplasty in trauma patients, but there is little consensus on the preferred method. The preferred surgical approach varies among hospitals and surgeons. Identifying the best possible approach for HA could lead to shorter hospital admission, faster rehabilitation, better functional outcomes, lower morbidity and mortality and improvement in patient independence. Consequently healthcare costs related to a hip fracture could be reduced.
As of today the clinical results, reoperation rate and the morbidity have improved significantly in hemiarthroplasty treatment for dislocated femoral neck fractures. However, patients are primarily operated with the lateral approach, although inferior results are reported compared to posterior and anterior approaches. RCT´s from Ugland et al and Mjaaland have shown increased incidence of limping, lateral thigh pain and inferior PROM´s in patients operated with the direct lateral approach compared to patients operated with anterior approaches.
A meta-analysis regarding hemiarthroplasty and surgical approaches from 2018 concluded that high-quality comparative studies are needed to further substantiate the preferred anatomic route for hemiarthroplasty in older femoral neck fracture patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are allocated to either an anterior approach or a posterior approach after inclusion. Both groups are operated with a cemented hemiarthroplasty
| Arm | Type | Receives |
|---|---|---|
| cemented hemiarthroplasty , posterior SPAIRE approach | Active comparator | Procedure: Posterior SPAIRE approach, anterior approachPosterior SPAIRE approach: lateral decubitus position, preservation of the piriformis tendon and obturator internus, detatchment of obturator externus , capsular T-incision, femoral neck resection, femoral canal reaming according to preoperative templating, third generation cementation technique, capsular repair, repair of obturator externus. |
| cemented hemiarthroplasty, anterior approach | Active comparator | Procedure: Posterior SPAIRE approach, anterior approachAnterior approach: supine position, both legs washed and draped, intermuscular plane between m. tensor fascia lata and m. sartorius, capsular T-incision, femoral neck resection, femoral canal reaming according to preoperative templating, third generation cementation technique, capsular repair |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Patients between 70 and 90 years of age
- Displaced FNF
- Ability to walk with or without a walking aid prior to falling
- Patients having Sorlandet Hospital as primary service provider for orthopaedic trauma
- Provision of informed consent by patient or proxy
Key exclusion criteria (6 listed)
- Dementia
- Fractures in pathologic bone
- Patients not suited for HA (i.e., inflammatory arthritis, severe osteoarthritis)
- Associated major injuries of the lower extremity ( i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula or femur)
- Retained hardware around the affected hip that will interfere with arthroplasty
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 |
|---|---|---|
| Posterior SPAIRE approach, anterior approachAlso: Bone Mineral Density, Biochemical muscle damage, Clinical muscle damageBased on power calculation a sub-group analysis of 50 patients will be examined with DXA, all patients for biochemical and clinical muscle damage (CK, CRP, TUG-test, Trendelenburg, strenght test) | Procedure or surgery | cemented hemiarthroplasty , posterior SPAIRE approach, cemented hemiarthroplasty, anterior approach |
Primary outcome
Harris Hip Score
Time frame: 2 years
The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent patient reported outcome measured by Harris Hip Score.
9 secondary outcomes
Bone Mineral Density
Time frame: 2 years
Muscle damage
Time frame: 2 years
Muscle damage
Time frame: 2 years
Muscle damage
Time frame: 2 years
Muscle damage
Time frame: 2 years
Health-related quality of life (HRQoL)
Time frame: 2 years
Health-related quality of life (HRQoL)
Time frame: 2 years
Health-related quality of life (HRQoL)
Time frame: 2 years
Radiographic stem positioning
Time frame: 2 years
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 8 May 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.
Lars Nordsletten, MD,PhD,Professor study director
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior SPAIRE approach, anterior approach in people with Femoral Neck Fractures and Bone Mineral Density, run by Sorlandet Hospital HF at 2 sites 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 6 inclusion and 6 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 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (time frame: 2 years). 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 8 May 2026.