- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Västernorrlands län
-
Sundsvall, Västernorrlands län, Sverige, 851 86
- Orthopaedic department, Sundsvall hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Femoral neck fracture
- Treated with Hemiarthroplasty
- Through a posterolateral approach
Exclusion Criteria:
- Direct lateral approach
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Femoral offset
Tidsramme: 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
Tidsramme: 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.
|
6 months to 7 years
|
|
Wiberg angle
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
1 year mortality
Tidsramme: one year
|
one year
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Arkan S Sayed-Noor, MD,PhD,FRCS, Orthopaedic department, Sundsvalls sjukhus, Landstinget Västernorrland
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SMASN
- SM
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