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Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty (APAF)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01486641
First Posted: December 6, 2011
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sundsvall Hospital
  Purpose
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.

Condition Intervention
Femoral Neck Fracture Procedure: Anterolateral approach

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty - a Change in Approach at Sundsvall Hospital.

Resource links provided by NLM:


Further study details as provided by Sundsvall Hospital:

Primary Outcome Measures:
  • Womac [ Time Frame: 1 year postoperatively ]

Secondary Outcome Measures:
  • EQ5D [ Time Frame: 1 year postoperatively ]
  • Harris Hip Score [ Time Frame: 1 year postoperatively ]

Estimated Enrollment: 160
Study Start Date: February 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anterolateral approach

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
Anterolateral approach acording to Gammer for hip arthroplasty.
Other Names:
  • Anterolateral approach according to Gammer.
  • Lubinus total hip arthroplasty or varikopf hemiarthroplasty.
No Intervention: Posterolateral approach

Patients with a displaced femoral neck fracture operated through the posterolateral approach to the hip arthroplasty.

Lubinus total hip arthroplasty or varikopf hemiarthroplasty.


Detailed 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 65 years
  • Displaced femoral neck fracture

Exclusion Criteria:

  • Pathologic fracture
  • Not Swedish speaker
  • Not living in Västernorrlands county
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486641


Locations
Sweden
Sundsvall Hospital
Sundsvall, Västernorrlands län, Sweden, 851 86
Department of orthopedic surgery Sundsvall Hospital
Sundsvall, Sweden, 851 86
Sponsors and Collaborators
Sundsvall Hospital
Investigators
Principal Investigator: Arkan S Sayed-Noor Umeå University
  More Information

Publications:
Responsible Party: Sundsvall Hospital
ClinicalTrials.gov Identifier: NCT01486641     History of Changes
Other Study ID Numbers: Sebastian-12
First Submitted: December 2, 2011
First Posted: December 6, 2011
Last Update Posted: August 2, 2017
Last Verified: April 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication in an international peer-review journal.
Time Frame: Publishing resultat in 2017
Access Criteria: Open Access

Keywords provided by Sundsvall Hospital:
femoral neck fracture
arthroplasty
surgical approach
anterolateral
posterolateral

Additional relevant MeSH terms:
Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries