Hadassah Medical Organization
Jerusalem, Israel
NCT Number: NCT00789048
Goal of the research
1. To check the viability of "Operating Table Position Simulating Radiographs", while positioned on the contralateral side. 2. 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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Jerusalem, Israel
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
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One radiograph with the patient lying on his contralateral side
Time frame: 3 days
Hadassah Medical Organization
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07595510
Arthritis, Bone Diseases
Kalisz, Greater Poland Voivodeship, Poland
View Trial DetailsNCT04057651
Arthritis, Hip Osteoarthritis
Lille, France
View Trial DetailsNCT05647629
Arthritis, Arthropathy of Hip
Valencia, Spain
View Trial DetailsNCT06744582
Arthritis, Hip Osteoarthritis
Bournemouth, Dorset, United Kingdom
View Trial Details