Femoral Neck FracturesNCT03974698
Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach
A study testing Hemiarthroplasty in people with Femoral Neck Fractures and Hemiarthroplasty, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach. Comparing leg length discrepancy, femoral offset, valgus/varus position of the stem. Also is there a difference in heterotopic ossification at 12 months. Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Femoral Neck Fractures, Hemiarthroplasty, Heterotopic Ossification
- What is being tested?
- Hemiarthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2014to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 with displaced femoral neck fractures
- Intact cognitive function
- Ability to walk with or without a walking aid prior to falling.
Who cannot join
- Dementia
- Fractures in pathologic bone
- Patients not belonging to the hospital community
- Patients with sepsis or local infection
- Fracture not eligible to be treated with a hemiarthroplasty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach: A Follow-up of a Randomized Controlled Trial.
Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach. Comparing leg length discrepancy, femoral offset, valgus/varus position of the stem. Also is there a difference in heterotopic ossification at 12 months.
Read the detailed description
Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand, Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468). This study is a follow-up on the same study population.
150 patients (70 to 90 years) with a displaced femoral neck fracture was randomized to be operated With either anterolateral og Direct lateral surgical approach. Investigators want to compare the radiological features of the femoral stem between the two Groups.
- Being tested
- Hemiarthroplasty
- Keywords
- femoral offset, leg length discrepancy, valgus/varus position, Lateral approach, Anterolateral approach
- Medical subject headings
- Femoral Neck Fractures, Ossification, Heterotopic, Leg Length Inequality, Genu Valgum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemiarthroplastyProcedure or surgery
Radiological features comparing the femoral stem position is measured on the postoperative x-ray. Presence of heterotopic ossification is assessed on the 12 months follow up.
| Study group | Role | What they receive |
|---|---|---|
| Anterolateral approach | Active comparator | Standard x-ray on all operated patients was taken pre- and postoperative and at 3 and 12 moths. Including an AP pelvis and lateral view of the hip. Receives: Procedure: Hemiarthroplasty |
| Lateral approach | Active comparator | Standard x-ray on all operated patients was taken pre- and postoperative and at 3 and 12 moths. Including an AP pelvis and lateral view of the hip. Receives: Procedure: Hemiarthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg length
The perpendicular distance between a horizontal line passing through the lower edge of the teardrop to the ipsilateral center of the femoral head
Measured: Immediately after surgery
Secondary outcomes (4)
Femoral offset
The distance between the longitudinal axis of the femur to the centre of the femoral head and the distance from the centre of the femoral head to a perpendicular line passing through the medial edge of the teardrop
Measured: Immediately after surgery
Valgus/varus stem position
Stem position in relation to the femoral axis
Measured: Immediately after surgery
Heterotopic ossification
Classified as type 1-4 according to Brooker classification
Measured: 1 year
Canal fill ratio
Was evaluated at the following points; 2 cm above the lower trochanter, at the tip of the lower trochanter, 2 cm and 7 cm below the tip of lesser trochanter
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Feb 2014
- Primary completion31 Jul 2017
- Study completion31 Jul 2018
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.
- 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, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lars Nordsletten, Prof, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974698
- Sponsor's protocol ID
- Raymond Tellefsen
- Status last verified
- May 2019
- First submitted
- 27 May 2019
- Last updated
- 25 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg OH, Hugo Pripp A, Nordsletten L. Less periprosthetic bone loss following the anterolateral approach to the hip compared with the direct lateral approach. Acta Orthop. 2018 Feb;89(1):23-28. doi: 10.1080/17453674.2017.1387730. Epub 2017 Oct 17.
PubMed 29037093Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg OH, Pripp AH, Nordsletten L. Biomarkers of muscle damage increased in anterolateral compared to direct lateral approach to the hip in hemiarthroplasty: no correlation with clinical outcome : Short-term analysis of secondary outcomes from a randomized clinical trial in patients with a displaced femoral neck fracture. Osteoporos Int. 2018 Aug;29(8):1853-1860. doi: 10.1007/s00198-018-4557-y. Epub 2018 May 22.
PubMed 29789919Tellefsen RA, Ugland T, Bjorndal MM, Ugland S, Pripp AH, Nordsletten L. Increased risk of high-grade heterotopic ossification using direct lateral approach versus a muscle-sparing anterolateral approach to the hip: radiological results from a randomised trial in patients with a femoral neck fracture treated with hemiarthroplasty. Hip Int. 2023 Jul;33(4):789-796. doi: 10.1177/11207000221097639. Epub 2022 May 18.
PubMed 35585787
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach: A Follow-up of a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03974698
- Acronym / sponsor ID
- Raymond Tellefsen
- Keywords
- femoral offset, leg length discrepancy, valgus/varus position, Lateral approach, Anterolateral approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 5 Jun 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.
Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach. Comparing leg length discrepancy, femoral offset, valgus/varus position of the stem. Also is there a difference in heterotopic ossification at 12 months.
Detailed description
Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand, Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468). This study is a follow-up on the same study population.
150 patients (70 to 90 years) with a displaced femoral neck fracture was randomized to be operated With either anterolateral og Direct lateral surgical approach. Investigators want to compare the radiological features of the femoral stem between the two Groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterolateral approach | Active comparator | Procedure: HemiarthroplastyStandard x-ray on all operated patients was taken pre- and postoperative and at 3 and 12 moths. Including an AP pelvis and lateral view of the hip. |
| Lateral approach | Active comparator | Procedure: HemiarthroplastyStandard x-ray on all operated patients was taken pre- and postoperative and at 3 and 12 moths. Including an AP pelvis and lateral view of the hip. |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients between 70 and 90 years of age with displaced femoral neck fractures
- Intact cognitive function
- Ability to walk with or without a walking aid prior to falling.
Key exclusion criteria (5 listed)
- Dementia
- Fractures in pathologic bone
- Patients not belonging to the hospital community
- Patients with sepsis or local infection
- Fracture not eligible to be treated with a hemiarthroplasty
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 |
|---|---|---|
| HemiarthroplastyRadiological features comparing the femoral stem position is measured on the postoperative x-ray. Presence of heterotopic ossification is assessed on the 12 months follow up. | Procedure or surgery | Anterolateral approach, Lateral approach |
Primary outcome
Leg length
Time frame: Immediately after surgery
The perpendicular distance between a horizontal line passing through the lower edge of the teardrop to the ipsilateral center of the femoral head
4 secondary outcomes
Femoral offset
Time frame: Immediately after surgery
Valgus/varus stem position
Time frame: Immediately after surgery
Heterotopic ossification
Time frame: 1 year
Canal fill ratio
Time frame: Immediately after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Background: PubMed 29037093Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg OH, Hugo Pripp A, Nordsletten L. Less periprosthetic bone loss following the anterolateral approach to the hip compared with the direct lateral approach. Acta Orthop. 2018 Feb;89(1):23-28. doi: 10.1080/17453674.2017.1387730. Epub 2017 Oct 17.
- Background: PubMed 29789919Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg OH, Pripp AH, Nordsletten L. Biomarkers of muscle damage increased in anterolateral compared to direct lateral approach to the hip in hemiarthroplasty: no correlation with clinical outcome : Short-term analysis of secondary outcomes from a randomized clinical trial in patients with a displaced femoral neck fracture. Osteoporos Int. 2018 Aug;29(8):1853-1860. doi: 10.1007/s00198-018-4557-y. Epub 2018 May 22.
- Derived from this study: PubMed 35585787Tellefsen RA, Ugland T, Bjorndal MM, Ugland S, Pripp AH, Nordsletten L. Increased risk of high-grade heterotopic ossification using direct lateral approach versus a muscle-sparing anterolateral approach to the hip: radiological results from a randomised trial in patients with a femoral neck fracture treated with hemiarthroplasty. Hip Int. 2023 Jul;33(4):789-796. doi: 10.1177/11207000221097639. Epub 2022 May 18.
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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, Prof principal investigator
Oslo University 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 Hemiarthroplasty in people with Femoral Neck Fractures and Hemiarthroplasty, run by Sorlandet Hospital HF 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 5 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: finished, as of the sponsor's last update on 25 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Leg length (time frame: Immediately after 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 NCT03974698, 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 25 Jan 2021; AzTrials last refreshed its copy on 1 Nov 2026.