Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Hadassah Medical Organization |
---|---|
Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00789048 |
Goal of the research
Condition | Intervention |
---|---|
Hip Osteoarthritis |
Other: radiograph |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Influence of "Operating Table Position Simulating Radiographs" on Acetabular Cup Angle During Primary Total Hip Replacement |
Estimated Enrollment: | 100 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Surgeon doesn't see: No Intervention
The surgeon doesn't see the radiograph prior to surgery
|
|
Surgeon does see: Experimental
The surgeon can see the radiograph prior to surgery
|
Other: radiograph
One radiograph with the patient lying on his contralateral side
|
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:
Inclusion criteria:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: LEONID kANDEL, md | 00972507874328 | kandel@hadassah.org.il |
Israel | |
Hadassah Medical Organization | |
Jerusalem, Israel |
Responsible Party: | Hadassah Medical Organization ( Leonid Kandel ) |
Study ID Numbers: | cupangle-HMO-CTIL |
Study First Received: | November 9, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00789048 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
hip arthroplasty radiograph |
Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Rheumatic Diseases Osteoarthritis, Hip |