DislocationRRDHHRNCT02131987
Radiological Riskfactors for Dislocation of Hip Hemiarthroplasty
An observational study of Dislocation and Femoral Neck Fracture, run by Sundsvall Hospital at 1 site in Sweden.
Trial summary
Between January 1 2006 and December 31 2013, at our department 324 patients underwent hemiarthroplasty (HA) for displaced femoral-neck fracture with a bipolar prosthesis (Variokopf, Link®, Germany) by the use of the posteriolateral approach. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dislocation, Femoral Neck Fracture
- How many people
- 324 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2006to Dec 2013
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Between January 1 2006 and December 31 2013, at our department 324 patients underwent hemiarthroplasty (HA) for displaced femoral-neck fracture with a bipolar prosthesis (Variokopf, Link®, Germany) by the use of the posteriolateral approach. Patients with pathological fractures and HA performed with anterolateral approach were excluded.
Who may be able to join
- Femoral neck fracture
- Treated with Hemiarthroplasty
- Through a posterolateral approach
Who cannot join
- Direct lateral approach
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Orthopaedic department, Sundsvall hospital
Sundsvall, Västernorrland County, 851 86
About this study
Official title: Radiological Riskfactors for Dislocation of Hip Hemiarthroplasty Through a Posterolateral Approach as Treatment for Femoral Neck Fracture
Between January 1 2006 and December 31 2013, at our department 324 patients underwent hemiarthroplasty (HA) for displaced femoral-neck fracture with a bipolar prosthesis (Variokopf, Link®, Germany) by the use of the posteriolateral approach. Patients with pathological fractures and HA performed with direct lateral approach were excluded. A retrospective cohort study were conducted. Patients with prosthetic dislocation formed one group and patients without dislocation formed the control group.
As standard, post surgery radiographs (anteroposterior and lateral) were taken. After these were performed patient started weight bearing as soon as possible. Clinical data regarding patient demographics, details of the surgical procedure and the medical comorbidities were collected by the use of patient and operative records. Radiological analysis with position evaluation was performed using the post surgery radiographs by measuring Wiberg angle, inequality of leg length and femoral offset of the prostheses and compared with non-operated hip joint using the post surgery x-ray images.
Our hypothesis were that patients with single- or recurrent dislocations had shortened postoperative leg length, decreased femoral offsed and a Wiberg angle less than 25 degrees.
- Conditions
- Dislocation, Femoral Neck Fracture
- Keywords
- Dislocation, Hemiarthroplasty, Femoral neck fracture, Femoral offset, Leg length difference, Wiberg angle
- Medical subject headings
- Joint Dislocations, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dislocation | Patients operated with hip hemiarthroplasty for a femoral neck fracture with a postoperative dislocation of the prosthesis | |
| Non-dislocated | Patents without dislocation of a hemiarthroplasty for a femoral neck fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral offset
The femoral offset is measured on the postoperative X-ray. The result are compared between the groups of dislocated and non-dislocated patients.
Measured: 6 months up to 7 years
Leg length difference
Leg length difference is measured on the postoperative X-ray. The result are compared between the groups of dislocated and non-dislocated patients.
Measured: 6 months to 7 years
Wiberg angle
Wiberg angle is measured on the postoperative X-ray. The result are compared between the groups of dislocated and non-dislocated patients.
Measured: 6 months to 7 years
Secondary outcomes (1)
1 year mortality
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startJan 2006
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DislocationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sundsvall Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arkan S Sayed-Noor, MD,PhD,FRCS, Principal investigator, Orthopaedic department, Sundsvalls sjukhus, Landstinget Västernorrland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131987
- Sponsor's protocol ID
- SMASN
- Other IDs
- SM
- Acronym
- RRDHHR
- Status last verified
- Oct 2015
- First submitted
- 28 Apr 2014
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Madanat R, Makinen TJ, Ovaska MT, Soiva M, Vahlberg T, Haapala J. Dislocation of hip hemiarthroplasty following posterolateral surgical approach: a nested case-control study. Int Orthop. 2012 May;36(5):935-40. doi: 10.1007/s00264-011-1353-0. Epub 2011 Sep 20.
PubMed 21931967Ninh CC, Sethi A, Hatahet M, Les C, Morandi M, Vaidya R. Hip dislocation after modular unipolar hemiarthroplasty. J Arthroplasty. 2009 Aug;24(5):768-74. doi: 10.1016/j.arth.2008.02.019. Epub 2008 Jun 13.
PubMed 18555648Enocson A, Pettersson H, Ponzer S, Tornkvist H, Dalen N, Tidermark J. Quality of life after dislocation of hip arthroplasty: a prospective cohort study on 319 patients with femoral neck fractures with a one-year follow-up. Qual Life Res. 2009 Nov;18(9):1177-84. doi: 10.1007/s11136-009-9531-x. Epub 2009 Aug 28.
PubMed 19714486Mukka S, Lindqvist J, Peyda S, Broden C, Mahmood S, Hassany H, Sayed-Noor A. Dislocation of bipolar hip hemiarthroplasty through a postero-lateral approach for femoral neck fractures: A cohort study. Int Orthop. 2015 Jul;39(7):1277-82. doi: 10.1007/s00264-014-2642-1. Epub 2015 Jan 6.
PubMed 25557759
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Riskfactors for Dislocation of Hip Hemiarthroplasty Through a Posterolateral Approach as Treatment for Femoral Neck Fracture
- ClinicalTrials.gov ID
- NCT02131987
- Acronym / sponsor ID
- RRDHHR / SMASN
- Conditions
- Dislocation, Femoral Neck Fracture
- Keywords
- Dislocation, Hemiarthroplasty, Femoral neck fracture, Femoral offset, Leg length difference, Wiberg angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Sundsvall HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 May 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.
Between January 1 2006 and December 31 2013, at our department 324 patients underwent hemiarthroplasty (HA) for displaced femoral-neck fracture with a bipolar prosthesis (Variokopf, Link®, Germany) by the use of the posteriolateral approach. Patients with pathological fractures and HA performed with direct lateral approach were excluded. A retrospective cohort study were conducted. Patients with prosthetic dislocation formed one group and patients without dislocation formed the control group.
As standard, post surgery radiographs (anteroposterior and lateral) were taken. After these were performed patient started weight bearing as soon as possible. Clinical data regarding patient demographics, details of the surgical procedure and the medical comorbidities were collected by the use of patient and operative records. Radiological analysis with position evaluation was performed using the post surgery radiographs by measuring Wiberg angle, inequality of leg length and femoral offset of the prostheses and compared with non-operated hip joint using the post surgery x-ray images.
Our hypothesis were that patients with single- or recurrent dislocations had shortened postoperative leg length, decreased femoral offsed and a Wiberg angle less than 25 degrees.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dislocation | – | –Patients operated with hip hemiarthroplasty for a femoral neck fracture with a postoperative dislocation of the prosthesis |
| Non-dislocated | – | –Patents without dislocation of a hemiarthroplasty for a femoral neck fracture |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between January 1 2006 and December 31 2013, at our department 324 patients underwent hemiarthroplasty (HA) for displaced femoral-neck fracture with a bipolar prosthesis (Variokopf, Link®, Germany) by the use of the posteriolateral approach. Patients with pathological fractures and HA performed with anterolateral approach were excluded.
Key inclusion criteria (3 listed)
- Femoral neck fracture
- Treated with Hemiarthroplasty
- Through a posterolateral approach
Key exclusion criteria (1 listed)
- Direct lateral approach
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Femoral offset
Time frame: 6 months up to 7 years
The femoral offset is measured on the postoperative X-ray. The result are compared between the groups of dislocated and non-dislocated patients.
Leg length difference
Time frame: 6 months to 7 years
Leg length difference is measured on the postoperative X-ray. The result are compared between the groups of dislocated and non-dislocated patients.
Wiberg angle
Time frame: 6 months to 7 years
Wiberg angle is measured on the postoperative X-ray. The result are compared between the groups of dislocated and non-dislocated patients.
1 secondary outcome
1 year mortality
Time frame: one year
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 29 Oct 2015.
- Background: PubMed 21931967Madanat R, Makinen TJ, Ovaska MT, Soiva M, Vahlberg T, Haapala J. Dislocation of hip hemiarthroplasty following posterolateral surgical approach: a nested case-control study. Int Orthop. 2012 May;36(5):935-40. doi: 10.1007/s00264-011-1353-0. Epub 2011 Sep 20.
- Background: PubMed 18555648Ninh CC, Sethi A, Hatahet M, Les C, Morandi M, Vaidya R. Hip dislocation after modular unipolar hemiarthroplasty. J Arthroplasty. 2009 Aug;24(5):768-74. doi: 10.1016/j.arth.2008.02.019. Epub 2008 Jun 13.
- Background: PubMed 19714486Enocson A, Pettersson H, Ponzer S, Tornkvist H, Dalen N, Tidermark J. Quality of life after dislocation of hip arthroplasty: a prospective cohort study on 319 patients with femoral neck fractures with a one-year follow-up. Qual Life Res. 2009 Nov;18(9):1177-84. doi: 10.1007/s11136-009-9531-x. Epub 2009 Aug 28.
- Results publication: PubMed 25557759Mukka S, Lindqvist J, Peyda S, Broden C, Mahmood S, Hassany H, Sayed-Noor A. Dislocation of bipolar hip hemiarthroplasty through a postero-lateral approach for femoral neck fractures: A cohort study. Int Orthop. 2015 Jul;39(7):1277-82. doi: 10.1007/s00264-014-2642-1. Epub 2015 Jan 6.
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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, MD,PhD,FRCS principal investigator
Orthopaedic department, Sundsvalls sjukhus, Landstinget Västernorrland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dislocation and Femoral Neck Fracture, run by Sundsvall Hospital at 1 site 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 3 inclusion and 1 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 29 Oct 2015. 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 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?
Femoral offset (time frame: 6 months up to 7 years). The study lists 3 primary outcomes in all. 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 NCT02131987, which also lists 4 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 29 Oct 2015.