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

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00789048
First received: November 9, 2008
Last updated: April 27, 2011
Last verified: November 2008
  Purpose

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.

Condition Intervention
Hip Osteoarthritis
Other: radiograph

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Influence of "Operating Table Position Simulating Radiographs" on Acetabular Cup Angle During Primary Total Hip Replacement

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • acetabular cup angle [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Surgeon doesn't see
The surgeon doesn't see the radiograph prior to surgery
Experimental: Surgeon does see
The surgeon can see the radiograph prior to surgery
Other: radiograph
One radiograph with the patient lying on his contralateral side

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:

  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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789048

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Leonid Kandel, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00789048     History of Changes
Other Study ID Numbers: cupangle-HMO-CTIL
Study First Received: November 9, 2008
Last Updated: April 27, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
hip
arthroplasty
radiograph

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014