Femoral Neck FractureAPAFNCT01486641
Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty
A study testing Anterolateral approach in people with Femoral Neck Fracture, run by Sundsvall Hospital at 2 sites in Sweden.
Trial summary
The purpose of this study is to determine whether the anterolateral in comparison to posterolateral approach to the hip arthroplasty gives an equal or better clinical results. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femoral Neck Fracture
- What is being tested?
- Anterolateral approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesSweden
- Study dates
- Feb 2012to Jun 2015
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age > 65 years
- Displaced femoral neck fracture
Who cannot join
- Pathologic fracture
- Not Swedish speaker
- Not living in Västernorrlands county
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Sundsvall Hospital
Sundsvall, Västernorrland County, 851 86
Department of orthopedic surgery Sundsvall Hospital
Sundsvall, 851 86
About this study
Official title: Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty - a Change in Approach at Sundsvall Hospital.
The purpose of this study is to determine whether the anterolateral in comparison to posterolateral approach to the hip arthroplasty gives an equal or better clinical results.
Read the detailed description
The purpose of this study is to compare the anterolateral- to posterolateral approaches in patients suffering a displaced femoral neck fracture operated with an hip arthroplasty. Our hypothesis is that the anterolateral approach gives equal or better clinical function, health related quality of life and less complication and reoperations.
- Conditions
- Femoral Neck Fracture
- Being tested
- Anterolateral approach
- Keywords
- femoral neck fracture, arthroplasty, surgical approach, anterolateral, posterolateral
- 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.
Anterolateral approachProcedure or surgery
Also called Anterolateral approach according to Gammer., Lubinus total hip arthroplasty or varikopf hemiarthroplasty.
Anterolateral approach acording to Gammer for hip arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Anterolateral approach | Active comparator | Patients with a displaced femoral neck fracture operated through the anterolateral approach to the hip arthroplasty.
Lubinus total hip arthroplasty or varikopf hemiarthroplasty. Receives: Procedure: Anterolateral approach |
| Posterolateral approach | No intervention | Patients with a displaced femoral neck fracture operated through the posterolateral approach to the hip arthroplasty. Lubinus total hip arthroplasty or varikopf hemiarthroplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Womac
Measured: 1 year postoperatively
Secondary outcomes (2)
EQ5D
Measured: 1 year postoperatively
Harris Hip Score
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completionJun 2015
- Study completionJun 2015
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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sundsvall Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arkan S Sayed-Noor, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486641
- Sponsor's protocol ID
- Sebastian-12
- Acronym
- APAF
- Status last verified
- Apr 2014
- First submitted
- 2 Dec 2011
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Publication in an international peer-review journal.
Publications
Ritter MA, Harty LD, Keating ME, Faris PM, Meding JB. A clinical comparison of the anterolateral and posterolateral approaches to the hip. Clin Orthop Relat Res. 2001 Apr;(385):95-9. doi: 10.1097/00003086-200104000-00016.
PubMed 11302333Gore DR, Murray MP, Sepic SB, Gardner GM. Anterolateral compared to posterior approach in total hip arthroplasty: differences in component positioning, hip strength, and hip motion. Clin Orthop Relat Res. 1982 May;(165):180-7.
PubMed 7075057Skoldenberg O, Ekman A, Salemyr M, Boden H. Reduced dislocation rate after hip arthroplasty for femoral neck fractures when changing from posterolateral to anterolateral approach. Acta Orthop. 2010 Oct;81(5):583-7. doi: 10.3109/17453674.2010.519170.
PubMed 20860452
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty - a Change in Approach at Sundsvall Hospital.
- ClinicalTrials.gov ID
- NCT01486641
- Acronym / sponsor ID
- APAF / Sebastian-12
- Conditions
- Femoral Neck Fracture
- Keywords
- femoral neck fracture, arthroplasty, surgical approach, anterolateral, posterolateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sundsvall HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Dec 2011 (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.
The purpose of this study is to determine whether the anterolateral in comparison to posterolateral approach to the hip arthroplasty gives an equal or better clinical results.
Detailed description
The purpose of this study is to compare the anterolateral- to posterolateral approaches in patients suffering a displaced femoral neck fracture operated with an hip arthroplasty. Our hypothesis is that the anterolateral approach gives equal or better clinical function, health related quality of life and less complication and reoperations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterolateral approach | Active comparator | Procedure: Anterolateral approachPatients with a displaced femoral neck fracture operated through the anterolateral approach to the hip arthroplasty. Lubinus total hip arthroplasty or varikopf hemiarthroplasty. |
| Posterolateral approach | No intervention | –Patients with a displaced femoral neck fracture operated through the posterolateral approach to the hip arthroplasty. Lubinus total hip arthroplasty or varikopf hemiarthroplasty. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age > 65 years
- Displaced femoral neck fracture
Key exclusion criteria (3 listed)
- Pathologic fracture
- Not Swedish speaker
- Not living in Västernorrlands county
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 |
|---|---|---|
| Anterolateral approachAlso: Anterolateral approach according to Gammer., Lubinus total hip arthroplasty or varikopf hemiarthroplasty.Anterolateral approach acording to Gammer for hip arthroplasty. | Procedure or surgery | Anterolateral approach |
Primary outcome
Womac
Time frame: 1 year postoperatively
2 secondary outcomes
EQ5D
Time frame: 1 year postoperatively
Harris Hip Score
Time frame: 1 year postoperatively
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 2 Aug 2017.
- Background: PubMed 11302333Ritter MA, Harty LD, Keating ME, Faris PM, Meding JB. A clinical comparison of the anterolateral and posterolateral approaches to the hip. Clin Orthop Relat Res. 2001 Apr;(385):95-9. doi: 10.1097/00003086-200104000-00016.
- Background: PubMed 7075057Gore DR, Murray MP, Sepic SB, Gardner GM. Anterolateral compared to posterior approach in total hip arthroplasty: differences in component positioning, hip strength, and hip motion. Clin Orthop Relat Res. 1982 May;(165):180-7.
- Background: PubMed 20860452Skoldenberg O, Ekman A, Salemyr M, Boden H. Reduced dislocation rate after hip arthroplasty for femoral neck fractures when changing from posterolateral to anterolateral approach. Acta Orthop. 2010 Oct;81(5):583-7. doi: 10.3109/17453674.2010.519170.
- Individual participant dataSharing planned: Yes. Publication in an international peer-review journal.
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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.
Arkan S Sayed-Noor principal investigator
Umeå University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterolateral approach in people with Femoral Neck Fracture, run by Sundsvall Hospital at 2 sites in Sweden.
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 2 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: finished, as of the sponsor's last update on 2 Aug 2017. 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 Sweden. 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?
Womac (time frame: 1 year postoperatively). 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 NCT01486641, 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 2 Aug 2017.