Radiological Riskfactors for Dislocation of Hip Hemiarthroplasty

Femoral Neck Fracture Clinical Trial

— RRDHHR  

Official title:

Radiological Riskfactors for Dislocation of Hip Hemiarthroplasty Through a Posterolateral Approach as Treatment for Femoral Neck Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131987
• Other study ID #: SMASN
• Secondary ID: SM
• Status: Completed
• Phase: N/A
• First received: April 28, 2014
• Last updated: October 28, 2015
• Start date: January 2006
• Est. completion date: December 2013

Study information

• Verified date: October 2015
• Source: Sundsvall Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Femoral neck fracture

• Treated with Hemiarthroplasty

• Through a posterolateral approach

Exclusion Criteria:

• Direct lateral approach

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dislocation
• Dislocations
• Femoral Neck Fracture
• Femoral Neck Fractures
• Hip Dislocation

Locations

Country	Name	City	State
Sweden	Orthopaedic department, Sundsvall hospital	Sundsvall	Västernorrlands län

Sponsors (1)

Lead Sponsor	Collaborator
Sundsvall Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Enocson A, Pettersson H, Ponzer S, Törnkvist H, Dalén 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. — View Citation

Madanat R, Mäkinen 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. — View Citation

Mukka S, Lindqvist J, Peyda S, Brodén 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Femoral offset	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	No
Primary	Leg length difference	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	No
Primary	Wiberg angle	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	No
Secondary	1 year mortality		one year	No