Back to resultsAnterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty (APAF)
Primary Purpose
Femoral Neck Fracture
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Anterolateral approach
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fracture focused on measuring femoral neck fracture, arthroplasty, surgical approach, anterolateral, posterolateral
Eligibility Criteria
Inclusion Criteria:
- Age > 65 years
- Displaced femoral neck fracture
Exclusion Criteria:
- Pathologic fracture
- Not Swedish speaker
- Not living in Västernorrlands county
Sites / Locations
- Sundsvall Hospital
- Department of orthopedic surgery Sundsvall Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Anterolateral approach
Posterolateral approach
Arm Description
Patients with a displaced femoral neck fracture operated through the anterolateral approach to the hip arthroplasty. Lubinus total hip arthroplasty or varikopf hemiarthroplasty.
Patients with a displaced femoral neck fracture operated through the posterolateral approach to the hip arthroplasty. Lubinus total hip arthroplasty or varikopf hemiarthroplasty.
Outcomes
Primary Outcome Measures
Womac
Secondary Outcome Measures
EQ5D
Harris Hip Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01486641
Brief Title
Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty
Acronym
APAF
Official Title
Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty - a Change in Approach at Sundsvall Hospital.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sundsvall Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fracture
Keywords
femoral neck fracture, arthroplasty, surgical approach, anterolateral, posterolateral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anterolateral approach
Arm Type
Active Comparator
Arm Description
Patients with a displaced femoral neck fracture operated through the anterolateral approach to the hip arthroplasty.
Lubinus total hip arthroplasty or varikopf hemiarthroplasty.
Arm Title
Posterolateral approach
Arm Type
No Intervention
Arm Description
Patients with a displaced femoral neck fracture operated through the posterolateral approach to the hip arthroplasty.
Lubinus total hip arthroplasty or varikopf hemiarthroplasty.
Intervention Type
Procedure
Intervention Name(s)
Anterolateral approach
Other Intervention Name(s)
Anterolateral approach according to Gammer., Lubinus total hip arthroplasty or varikopf hemiarthroplasty.
Intervention Description
Anterolateral approach acording to Gammer for hip arthroplasty.
Primary Outcome Measure Information:
Title
Womac
Time Frame
1 year postoperatively
Secondary Outcome Measure Information:
Title
EQ5D
Time Frame
1 year postoperatively
Title
Harris Hip Score
Time Frame
1 year postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 65 years
Displaced femoral neck fracture
Exclusion Criteria:
Pathologic fracture
Not Swedish speaker
Not living in Västernorrlands county
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arkan S Sayed-Noor
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sundsvall Hospital
City
Sundsvall
State/Province
Västernorrlands län
ZIP/Postal Code
851 86
Country
Sweden
Facility Name
Department of orthopedic surgery Sundsvall Hospital
City
Sundsvall
ZIP/Postal Code
851 86
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication in an international peer-review journal.
IPD Sharing Time Frame
Publishing resultat in 2017
IPD Sharing Access Criteria
Open Access
Citations:
PubMed Identifier
11302333
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. doi: 10.1097/00003086-200104000-00016.
Results Reference
background
PubMed Identifier
7075057
Citation
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.
Results Reference
background
PubMed Identifier
20860452
Citation
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.
Results Reference
background
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Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty
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