- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02131987
Radiological Riskfactors for Dislocation of Hip Hemiarthroplasty (RRDHHR)
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
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Västernorrlands län
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Sundsvall, Västernorrlands län, Zweden, 851 86
- Orthopaedic department, Sundsvall hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Femoral neck fracture
- Treated with Hemiarthroplasty
- Through a posterolateral approach
Exclusion Criteria:
- Direct lateral approach
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
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Dislocation
Patients operated with hip hemiarthroplasty for a femoral neck fracture with a postoperative dislocation of the prosthesis
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Non-dislocated
Patents without dislocation of a hemiarthroplasty for a femoral neck fracture
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Femoral offset
Tijdsspanne: 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.
|
6 months up to 7 years
|
|
Leg length difference
Tijdsspanne: 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.
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6 months to 7 years
|
|
Wiberg angle
Tijdsspanne: 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.
|
6 months to 7 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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1 year mortality
Tijdsspanne: one year
|
one year
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Arkan S Sayed-Noor, MD,PhD,FRCS, Orthopaedic department, Sundsvalls sjukhus, Landstinget Västernorrland
Publicaties en nuttige links
Algemene publicaties
- 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.
- Ninh 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.
- Enocson 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.
- Mukka 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SMASN
- SM
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