The Influence of "Operating Table Position Simulating Radiographs" on Acetabular Cup Angle During Primary Total Hip Replacement

Hip Osteoarthritis Clinical Trial

Official title:

The Influence of "Operating Table Position Simulating Radiographs" on Acetabular Cup Angle During Primary Total Hip Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789048
• Other study ID #: cupangle-HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: November 9, 2008
• Last updated: April 27, 2011
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: November 2008
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

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:

1. Age>18

2. Candidate for primary total hip replacement

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age>18

2. Candidate for primary total hip replacement

3. Agrees to participate in the study

Exclusion Criteria:

1. Patient doesn't agree to participate in the study

2. Dysplastic hip, Crowe>1

3. After previous hip surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Other:
• radiograph
One radiograph with the patient lying on his contralateral side

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acetabular cup angle		3 days	No