Anterolateral Watson Jones Approach Versus Transgluteal Approach for Uncemented Hemi- Arthroplasty in Displaced Femoral Neck Fracture
Primary Purpose
Femoral Neck Fracture
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
hemiarthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fracture focused on measuring Femoral Neck Fracture, Anterolateral approach, Trans-gluteal approach, Watson Jones approach, Hardinge approach
Eligibility Criteria
Inclusion Criteria: Patients 70- 85 Years of Age -
Exclusion Criteria:
Dementia, Infection Not Suitable for Hemiarthroplasty
-
Sites / Locations
- Sorlandet Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Anterolateral Approach
Trans-gluteal Approach
Arm Description
Patient Operated with Watson Jones Approach
Patient operated with Trans-gluteal Hardinge Approach
Outcomes
Primary Outcome Measures
Visual Analogue Scale Pain and Patient Satisfaction
Secondary Outcome Measures
Timed up and go
TUG test- Timed up and Go
Harris Hip Score
Hip Osteoarthritis Disability Score
EuroQol
Full Information
NCT ID
NCT02028468
First Posted
January 3, 2014
Last Updated
November 9, 2022
Sponsor
Sorlandet Hospital HF
1. Study Identification
Unique Protocol Identification Number
NCT02028468
Brief Title
Anterolateral Watson Jones Approach Versus Transgluteal Approach for Uncemented Hemi- Arthroplasty in Displaced Femoral Neck Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF
4. Oversight
5. Study Description
Brief Summary
Hemiarthroplasty is a well established treatment of Femoral Neck Fractures in the Elderly. During the last decade the use of Minimal Invasive Surgical( MIS) approaches have been increasing. Our hypothesis is that Patients with a Femoral Neck Fracture may benefit from a MIS approach.
Detailed Description
The study's main objective: The purpose of the study is to test the following hypothesis. Patients 70 to 90 years with a displaced femoral neck fracture, operated with a hemiarthroplasty through an anterolateral approach, have less pain and better patient satisfaction as measured by PROMs than patients operated through the lateral approach.
The study's subsidiary objectives. We aim to shed light on the following subsidiary hypotheses.
A hemiarthroplasty inserted through an anterolateral approach gives less bone resorption, as measured by DEXA around the stem, than a hemiarthroplasty inserted via a direct lateral approach.
A hemiarthroplasty inserted through an anterolateral approach causes lesser degree of muscle damage, as measured by CK, than a direct lateral approach
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, Anterolateral approach, Trans-gluteal approach, Watson Jones approach, Hardinge approach
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anterolateral Approach
Arm Type
Active Comparator
Arm Description
Patient Operated with Watson Jones Approach
Arm Title
Trans-gluteal Approach
Arm Type
Active Comparator
Arm Description
Patient operated with Trans-gluteal Hardinge Approach
Intervention Type
Procedure
Intervention Name(s)
hemiarthroplasty
Primary Outcome Measure Information:
Title
Visual Analogue Scale Pain and Patient Satisfaction
Time Frame
Pre and postoperative, 3 and 12 Months
Secondary Outcome Measure Information:
Title
Timed up and go
Description
TUG test- Timed up and Go
Time Frame
postoperative, 3 and 12 Monthes
Title
Harris Hip Score
Time Frame
Pre / Postoperative, 3 and 12 Months
Title
Hip Osteoarthritis Disability Score
Time Frame
Postoperative, 3 and 12 Months
Title
EuroQol
Time Frame
Postoperative, 3 and 12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients 70- 85 Years of Age -
Exclusion Criteria:
Dementia, Infection Not Suitable for Hemiarthroplasty
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Nordsletten, Professor
Organizational Affiliation
University of Oslo Ullevål
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sorlandet Hospital
City
Kristiansand
ZIP/Postal Code
4604
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
29789919
Citation
Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg OH, Pripp AH, Nordsletten L. Biomarkers of muscle damage increased in anterolateral compared to direct lateral approach to the hip in hemiarthroplasty: no correlation with clinical outcome : Short-term analysis of secondary outcomes from a randomized clinical trial in patients with a displaced femoral neck fracture. Osteoporos Int. 2018 Aug;29(8):1853-1860. doi: 10.1007/s00198-018-4557-y. Epub 2018 May 22.
Results Reference
derived
Learn more about this trial
Anterolateral Watson Jones Approach Versus Transgluteal Approach for Uncemented Hemi- Arthroplasty in Displaced Femoral Neck Fracture
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