NCT01486641

Brief Summary

The purpose of this study is to determine whether the anterolateral in comparison to posterolateral approach to the hip arthroplasty gives an equal or better clinical results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

December 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 2, 2017

Status Verified

April 1, 2014

Enrollment Period

3.3 years

First QC Date

December 2, 2011

Last Update Submit

July 31, 2017

Conditions

Keywords

femoral neck fracturearthroplastysurgical approachanterolateralposterolateral

Outcome Measures

Primary Outcomes (1)

  • Womac

    1 year postoperatively

Secondary Outcomes (2)

  • EQ5D

    1 year postoperatively

  • Harris Hip Score

    1 year postoperatively

Study Arms (2)

Anterolateral approach

ACTIVE COMPARATOR

Patients with a displaced femoral neck fracture operated through the anterolateral approach to the hip arthroplasty. Lubinus total hip arthroplasty or varikopf hemiarthroplasty.

Procedure: Anterolateral approach

Posterolateral approach

NO INTERVENTION

Patients with a displaced femoral neck fracture operated through the posterolateral approach to the hip arthroplasty. Lubinus total hip arthroplasty or varikopf hemiarthroplasty.

Interventions

Anterolateral approach acording to Gammer for hip arthroplasty.

Also known as: Anterolateral approach according to Gammer., Lubinus total hip arthroplasty or varikopf hemiarthroplasty.
Anterolateral approach

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age \> 65 years
  • Displaced femoral neck fracture

You may not qualify if:

  • Pathologic fracture
  • Not Swedish speaker
  • Not living in Västernorrlands county

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sundsvall Hospital

Sundsvall, Västernorrland County, 851 86, Sweden

Location

Department of orthopedic surgery Sundsvall Hospital

Sundsvall, 851 86, Sweden

Location

Related Publications (3)

  • Ritter MA, Harty LD, Keating ME, Faris PM, Meding JB. A clinical comparison of the anterolateral and posterolateral approaches to the hip. Clin Orthop Relat Res. 2001 Apr;(385):95-9. doi: 10.1097/00003086-200104000-00016.

    PMID: 11302333BACKGROUND
  • Gore DR, Murray MP, Sepic SB, Gardner GM. Anterolateral compared to posterior approach in total hip arthroplasty: differences in component positioning, hip strength, and hip motion. Clin Orthop Relat Res. 1982 May;(165):180-7.

    PMID: 7075057BACKGROUND
  • 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

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Arkan S Sayed-Noor

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2011

First Posted

December 6, 2011

Study Start

February 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 2, 2017

Record last verified: 2014-04

Data Sharing

IPD Sharing
Will share

Publication in an international peer-review journal.

Time Frame
Publishing resultat in 2017
Access Criteria
Open Access

Locations