Overview

This trial is active, not recruiting.

Condition femoral neck fracture
Treatment anterolateral approach
Sponsor Sundsvall Hospital
Start date February 2012
End date June 2015
Trial size 160 participants
Trial identifier NCT01486641, Sebastian-12

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
anterolateral approach Anterolateral approach according to Gammer.
Anterolateral approach acording to Gammer for hip arthroplasty.
(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.

Primary Outcomes

Measure
Womac
time frame: 1 year postoperatively

Secondary Outcomes

Measure
EQ5D
time frame: 1 year postoperatively
Harris Hip Score
time frame: 1 year postoperatively

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: - Age > 65 years - Displaced femoral neck fracture (Garden 3-4) - Independent walker with or without help Exclusion Criteria: - Pathologic fracture - Not independent walker - Contradiction to arthroplasty by other condition (opened wound, ASA > 4, severe blood clotting deficiency). - Not Swedish speaker - Not living in Västernorrlands county

Additional Information

Official title Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty - a Change in Approach at Sundsvall Hospital.
Description The purpose of this study is to compare the anterolateral- to posterolateral approaches in patients suffering a displaced femoral neck fracture operated with an hip arthroplasty. Our hypothesis is that the anterolateral approach gives equal or better clinical function, health related quality of life and less complication and reoperations.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Sundsvall Hospital.