NCT02131987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

7.9 years

First QC Date

April 28, 2014

Last Update Submit

October 28, 2015

Conditions

Keywords

DislocationHemiarthroplastyFemoral neck fractureFemoral offsetLeg length differenceWiberg angle

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (1)

  • 1 year mortality

    one year

Study Arms (2)

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

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Direct lateral approach

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic department, Sundsvall hospital

Sundsvall, Västernorrland County, 851 86, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 21931967BACKGROUND
  • 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.

    PMID: 18555648BACKGROUND
  • 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.

    PMID: 19714486BACKGROUND
  • 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.

MeSH Terms

Conditions

Joint DislocationsFemoral Neck Fractures

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip FracturesFemoral FracturesFractures, BoneHip InjuriesLeg Injuries

Study Officials

  • Arkan S Sayed-Noor, MD,PhD,FRCS

    Orthopaedic department, Sundsvalls sjukhus, Landstinget Västernorrland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 6, 2014

Study Start

January 1, 2006

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations