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

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ClinicalTrials.gov Identifier: NCT01486641
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Sundsvall Hospital

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.

Condition or disease Intervention/treatment Phase
Femoral Neck Fracture Procedure: Anterolateral approach Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
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.
Study Start Date : February 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.




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

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


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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

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

Publications:
Responsible Party: Sundsvall Hospital
ClinicalTrials.gov Identifier: NCT01486641     History of Changes
Other Study ID Numbers: Sebastian-12
First Posted: December 6, 2011    Key Record Dates
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