- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Västernorrlands län
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Sundsvall, Västernorrlands län, Sweden, 851 86
- Orthopaedic department, Sundsvall hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Femoral neck fracture
- Treated with Hemiarthroplasty
- Through a posterolateral approach
Exclusion Criteria:
- Direct lateral approach
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Femoral offset
Time Frame: 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
Time Frame: 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
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1 year mortality
Time Frame: one year
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one year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arkan S Sayed-Noor, MD,PhD,FRCS, Orthopaedic department, Sundsvalls sjukhus, Landstinget Västernorrland
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMASN
- SM
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