Clinical trial NCT02131987: Radiological Riskfactors for Dislocation of Hip Hemiarthroplasty
Official title: Radiological Riskfactors for Dislocation of Hip Hemiarthroplasty Through a Posterolateral Approach as Treatment for Femoral Neck Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dislocation
Femoral Neck Fracture
Keywords: Dislocation
Hemiarthroplasty
Femoral neck fracture
Femoral offset
Leg length difference
Wiberg angle
Lead sponsor: Sundsvall Hospital
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 324
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Femoral neck fracture
* Treated with Hemiarthroplasty
* Through a posterolateral approach

Exclusion Criteria:

* Direct lateral approach

Primary outcomes:
measure: Femoral offset
timeFrame: 6 months up to 7 years
measure: Leg length difference
timeFrame: 6 months to 7 years
measure: Wiberg angle
timeFrame: 6 months to 7 years
Secondary outcomes:
measure: 1 year mortality
timeFrame: one year
Other outcomes:
Locations:
city: Sundsvall
country: Sweden
facility: Orthopaedic department, Sundsvall hospital
state: Västernorrlands län
Study officials:
affiliation: Orthopaedic department, Sundsvalls sjukhus, Landstinget Västernorrland
name: Arkan S Sayed-Noor, MD,PhD,FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.