- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Västernorrlands län
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Sundsvall, Västernorrlands län, Suède, 851 86
- Orthopaedic department, Sundsvall hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Femoral neck fracture
- Treated with Hemiarthroplasty
- Through a posterolateral approach
Exclusion Criteria:
- Direct lateral approach
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Femoral offset
Délai: 6 months up to 7 years
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The femoral offset 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 up to 7 years
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Leg length difference
Délai: 6 months to 7 years
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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
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Wiberg angle
Délai: 6 months to 7 years
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Wiberg angle 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
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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1 year mortality
Délai: one year
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one year
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Arkan S Sayed-Noor, MD,PhD,FRCS, Orthopaedic department, Sundsvalls sjukhus, Landstinget Västernorrland
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SMASN
- SM
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