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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01486641
Other study ID # Sebastian-12
Secondary ID
Status Completed
Phase N/A
First received December 2, 2011
Last updated July 31, 2017
Start date February 2012
Est. completion date June 2015

Study information

Verified date April 2014
Source Sundsvall Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Age > 65 years

- Displaced femoral neck fracture

Exclusion Criteria:

- Pathologic fracture

- Not Swedish speaker

- Not living in Västernorrlands county

Study Design


Intervention

Procedure:
Anterolateral approach
Anterolateral approach acording to Gammer for hip arthroplasty.

Locations

Country Name City State
Sweden Department of orthopedic surgery Sundsvall Hospital Sundsvall
Sweden Sundsvall Hospital Sundsvall Västernorrlands län

Sponsors (1)

Lead Sponsor Collaborator
Sundsvall Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View Citation

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. — View Citation

Sköldenberg O, Ekman A, Salemyr M, Bodén 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Womac 1 year postoperatively
Secondary EQ5D 1 year postoperatively
Secondary Harris Hip Score 1 year postoperatively
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