The Influence of "Operating Table Position Simulating Radiographs" on Acetabular Cup Angle During Primary Total Hip Replacement
Primary Purpose
Hip Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
radiograph
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring hip, arthroplasty, radiograph
Eligibility Criteria
Inclusion Criteria:
- Age>18
- Candidate for primary total hip replacement
- Agrees to participate in the study
Exclusion Criteria:
- Patient doesn't agree to participate in the study
- Dysplastic hip, Crowe>1
- After previous hip surgery
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Surgeon doesn't see
Surgeon does see
Arm Description
The surgeon doesn't see the radiograph prior to surgery
The surgeon can see the radiograph prior to surgery
Outcomes
Primary Outcome Measures
acetabular cup angle
Secondary Outcome Measures
Full Information
NCT ID
NCT00789048
First Posted
November 9, 2008
Last Updated
April 27, 2011
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00789048
Brief Title
The Influence of "Operating Table Position Simulating Radiographs" on Acetabular Cup Angle During Primary Total Hip Replacement
Official Title
The Influence of "Operating Table Position Simulating Radiographs" on Acetabular Cup Angle During Primary Total Hip Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Goal of the research
To check the viability of "Operating Table Position Simulating Radiographs", while positioned on the contralateral side.
To determine whether knowledge about the angles displayed on this radiograph (pelvic tilt) influences the accurate positioning of the acetabular cup during the Total Hip Replacement procedure.
Detailed Description
Type of research:
A prospective study.
Population:
A power study has been calculated in order to define the sample size. The results indicated that the following sample size will suffice:
Study group: 50 consecutive patients undergoing a primary total hip replacement procedure
Control group: 50 consecutive patients undergoing a primary total hip replacement procedure
Inclusion criteria:
Age>18
Candidate for primary total hip replacement
Agrees to participate in the study
Exclusion criteria:
1. Patient doesn't agree to participate in the study
Protocol:
Patients included in the research group and in the control group will undergo an "Operating Table Position Simulating " radiograph of the pelvis. The radiograph will be done in the following manner: the patient will be potisioned on the non-operated side in such way that his pelvis is perpendicular to the table. The legs are flexed in 30 degrees at the hip joints and 30 degrees at the knees. The plate with a grid will be placed behind the pelvis in a device with notches (which can be used to measure the angles later). After the total hip replacement the patients will undergo an A-P radiograph of the hip joints while lying on the back with the hip joints bent to 30 degrees to overcome the forward tilt of the pelvis. All of the radiographs will be performed in the presence of an orthopedic surgeon.
The control group will be the first group of patients. Their radiographs will be stored in a standalone file with controlled access rather than the general PACS system. The file will be opened only when the study is over. The radiologist will control the file and be responsible for this stage.
The study group will be the next group of patients. In this group the radiographs will be saved in the general PACS system. The radiographs with measurement of the lateral inclination of the pelvis, while lying in an "Operating Table Position" will be shown to the chief surgeon on the day of surgery or one day prior to it.
Both chief surgeons will not know about the study until the end of it. At the end of the study, a comparison of both groups' acetabular cup angles will be done. The angles will be measured twice. The first measurement will be done by a senior orthopedic surgeon specializing in joint replacement operations. The second one will be done by a senior radiologist specialized in skeletal radiology. If a difference of 5 degrees or more is found between the two measurements, a third measurement will be done by a third examiner.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
hip, arthroplasty, radiograph
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgeon doesn't see
Arm Type
No Intervention
Arm Description
The surgeon doesn't see the radiograph prior to surgery
Arm Title
Surgeon does see
Arm Type
Experimental
Arm Description
The surgeon can see the radiograph prior to surgery
Intervention Type
Other
Intervention Name(s)
radiograph
Intervention Description
One radiograph with the patient lying on his contralateral side
Primary Outcome Measure Information:
Title
acetabular cup angle
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age>18
Candidate for primary total hip replacement
Agrees to participate in the study
Exclusion Criteria:
Patient doesn't agree to participate in the study
Dysplastic hip, Crowe>1
After previous hip surgery
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Influence of "Operating Table Position Simulating Radiographs" on Acetabular Cup Angle During Primary Total Hip Replacement
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