NCT02247661

Brief Summary

A prospective cohort study to compare the direct lateral and poster-lateral approach concerning abductor function. Patients admitted with a femoral neck fracture operated with a hemiarthroplasty through a direct lateral or a poster-lateral approach were screened for inclusion. Patients with altered mental status SPMSQ \>7, pathological fractures, non-walkers were excluded. Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 1 year postoperatively by clinical examination. Sample size were estimated to 30 patient in each group. Primary outcome variables were trendelenburg test, abductor strength measured with dynamometry, trochanteric tenderness measured with algometry and palptation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Typical duration 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

February 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

3 years

First QC Date

September 20, 2014

Last Update Submit

October 13, 2015

Conditions

Keywords

Femoral neck fracture,surgical approach, limp, abductor strenght, trochanteric pain

Outcome Measures

Primary Outcomes (1)

  • Trendelenburg Test

    30 seconds standing on the operated leg

    1 year

Secondary Outcomes (3)

  • Abductor strenght

    1 year

  • Trochanteric tenderness

    1 year

  • Trochanteric tenderness

    1 year

Study Arms (2)

Direct lateral approach

Total or hemiarthroplasty operated with direct-lateral approach.

Postero-lateral approach

Total or hemiarthroplasty operated with postero-lateral approach.

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to Sundsvall hospital with a displaced femoral neck fracture operated with either a total or hemiarthroplasty.

You may qualify if:

  • Displaced femoral neck fracture
  • Walker
  • Hemarthroplasty
  • Preiffer test \>7/10

You may not qualify if:

  • Pathological fracture
  • Non-walker
  • Pfeiffer test \<7/10 indicating mental alteration.

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 (3)

  • Skoldenberg O, Ekman A, Salemyr M, Boden H. Reduced dislocation rate after hip arthroplasty for femoral neck fractures when changing from posterolateral to anterolateral approach. Acta Orthop. 2010 Oct;81(5):583-7. doi: 10.3109/17453674.2010.519170.

    PMID: 20860452BACKGROUND
  • Pai VS. Significance of the Trendelenburg test in total hip arthroplasty. Influence of lateral approaches. J Arthroplasty. 1996 Feb;11(2):174-9. doi: 10.1016/s0883-5403(05)80013-0.

    PMID: 8648312BACKGROUND
  • Kiyama T, Naito M, Shinoda T, Maeyama A. Hip abductor strengths after total hip arthroplasty via the lateral and posterolateral approaches. J Arthroplasty. 2010 Jan;25(1):76-80. doi: 10.1016/j.arth.2008.11.001. Epub 2009 Apr 8.

    PMID: 19359133BACKGROUND

MeSH Terms

Conditions

Femoral Neck FracturesIntermittent Claudication

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPeripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head FoU

Study Record Dates

First Submitted

September 20, 2014

First Posted

September 25, 2014

Study Start

February 1, 2012

Primary Completion

February 1, 2015

Study Completion

May 1, 2015

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations