Femoral Neck FractureNCT02028468
Anterolateral Watson Jones Approach Versus Transgluteal Approach for Uncemented Hemi- Arthroplasty in Displaced Femoral Neck Fracture
A study testing hemiarthroplasty in people with Femoral Neck Fracture, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
Hemiarthroplasty is a well established treatment of Femoral Neck Fractures in the Elderly. During the last decade the use of Minimal Invasive Surgical( MIS) approaches have been increasing. Our hypothesis is that Patients with a Femoral Neck Fracture may benefit from a MIS approach. Read more about this study
- Who is it for?
- Ages 70 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoral Neck Fracture
- 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
- Feb 2014to 11 Mar 2022
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
None listed.
Who cannot join
- Dementia, Infection Not Suitable for Hemiarthroplasty
- -
Trial locations and contacts
1 site in 1 country.
About this study
Hemiarthroplasty is a well established treatment of Femoral Neck Fractures in the Elderly. During the last decade the use of Minimal Invasive Surgical( MIS) approaches have been increasing. Our hypothesis is that Patients with a Femoral Neck Fracture may benefit from a MIS approach.
Read the detailed description
The study's main objective: The purpose of the study is to test the following hypothesis. Patients 70 to 90 years with a displaced femoral neck fracture, operated with a hemiarthroplasty through an anterolateral approach, have less pain and better patient satisfaction as measured by PROMs than patients operated through the lateral approach.
The study's subsidiary objectives. We aim to shed light on the following subsidiary hypotheses.
- A hemiarthroplasty inserted through an anterolateral approach gives less bone resorption, as measured by DEXA around the stem, than a hemiarthroplasty inserted via a direct lateral approach.
- A hemiarthroplasty inserted through an anterolateral approach causes lesser degree of muscle damage, as measured by CK, than a direct lateral approach
- Conditions
- Femoral Neck Fracture
- Being tested
- hemiarthroplasty
- Keywords
- Femoral Neck Fracture, Anterolateral approach, Trans-gluteal approach, Watson Jones approach, Hardinge 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.
hemiarthroplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Anterolateral Approach | Active comparator | Patient Operated with Watson Jones Approach Receives: Procedure: hemiarthroplasty |
| Trans-gluteal Approach | Active comparator | Patient operated with Trans-gluteal Hardinge Approach Receives: Procedure: hemiarthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale Pain and Patient Satisfaction
Measured: Pre and postoperative, 3 and 12 Months
Secondary outcomes (4)
Timed up and go
TUG test- Timed up and Go
Measured: postoperative, 3 and 12 Monthes
Harris Hip Score
Measured: Pre / Postoperative, 3 and 12 Months
Hip Osteoarthritis Disability Score
Measured: Postoperative, 3 and 12 Months
EuroQol
Measured: Postoperative, 3 and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2018
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lars Nordsletten, Professor, Principal investigator, University of Oslo Ullevål
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028468
- Sponsor's protocol ID
- 811419
- Status last verified
- Mar 2022
- First submitted
- 3 Jan 2014
- Last updated
- 10 Nov 2022
- Results posted
- No
Publications
Ugland 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 29789919
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterolateral Watson Jones Approach Versus Transgluteal Approach for Uncemented Hemi- Arthroplasty in Displaced Femoral Neck Fracture
- ClinicalTrials.gov ID
- NCT02028468
- Acronym / sponsor ID
- 811419
- Conditions
- Femoral Neck Fracture
- Keywords
- Femoral Neck Fracture, Anterolateral approach, Trans-gluteal approach, Watson Jones approach, Hardinge approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Feb 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 7 Jan 2014 (estimated)
- 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.
Hemiarthroplasty is a well established treatment of Femoral Neck Fractures in the Elderly. During the last decade the use of Minimal Invasive Surgical( MIS) approaches have been increasing. Our hypothesis is that Patients with a Femoral Neck Fracture may benefit from a MIS approach.
Detailed description
The study's main objective: The purpose of the study is to test the following hypothesis. Patients 70 to 90 years with a displaced femoral neck fracture, operated with a hemiarthroplasty through an anterolateral approach, have less pain and better patient satisfaction as measured by PROMs than patients operated through the lateral approach.
The study's subsidiary objectives. We aim to shed light on the following subsidiary hypotheses.
- A hemiarthroplasty inserted through an anterolateral approach gives less bone resorption, as measured by DEXA around the stem, than a hemiarthroplasty inserted via a direct lateral approach.
- A hemiarthroplasty inserted through an anterolateral approach causes lesser degree of muscle damage, as measured by CK, than a direct lateral approach
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterolateral Approach | Active comparator | Procedure: hemiarthroplastyPatient Operated with Watson Jones Approach |
| Trans-gluteal Approach | Active comparator | Procedure: hemiarthroplastyPatient operated with Trans-gluteal Hardinge Approach |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Dementia, Infection Not Suitable for 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 |
|---|---|---|
| hemiarthroplasty | Procedure or surgery | Anterolateral Approach, Trans-gluteal Approach |
Primary outcome
Visual Analogue Scale Pain and Patient Satisfaction
Time frame: Pre and postoperative, 3 and 12 Months
4 secondary outcomes
Timed up and go
Time frame: postoperative, 3 and 12 Monthes
Harris Hip Score
Time frame: Pre / Postoperative, 3 and 12 Months
Hip Osteoarthritis Disability Score
Time frame: Postoperative, 3 and 12 Months
EuroQol
Time frame: Postoperative, 3 and 12 Months
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 10 Nov 2022.
- Derived from this study: 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.
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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, Professor principal investigator
University of Oslo Ullevål
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 Fracture, 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 0 inclusion and 2 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 10 Nov 2022. 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?
Visual Analogue Scale Pain and Patient Satisfaction (time frame: Pre and postoperative, 3 and 12 Months). 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 NCT02028468, which also lists 1 linked publication.
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 10 Nov 2022.