Hip OsteoarthritisNCT00789048
The Influence of "Operating Table Position Simulating Radiographs" on Acetabular Cup Angle During Primary Total Hip Replacement
A study testing radiograph in people with Hip Osteoarthritis, run by Hadassah Medical Organization at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- radiograph
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18
- Candidate for primary total hip replacement
- Agrees to participate in the study
Who cannot join
- Patient doesn't agree to participate in the study
- Dysplastic hip, Crowe>1
- After previous hip surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- radiograph
- Keywords
- hip, arthroplasty, radiograph
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiographOther
One radiograph with the patient lying on his contralateral side
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: radiograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
acetabular cup angle
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789048
- Sponsor's protocol ID
- cupangle-HMO-CTIL
- Status last verified
- Nov 2008
- First submitted
- 9 Nov 2008
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of "Operating Table Position Simulating Radiographs" on Acetabular Cup Angle During Primary Total Hip Replacement
- ClinicalTrials.gov ID
- NCT00789048
- Acronym / sponsor ID
- cupangle-HMO-CTIL
- Conditions
- Hip Osteoarthritis
- Keywords
- hip, arthroplasty, radiograph
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgeon doesn't see | No intervention | –The surgeon doesn't see the radiograph prior to surgery |
| Surgeon does see | Experimental | Other: radiographThe surgeon can see the radiograph prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>18
- Candidate for primary total hip replacement
- Agrees to participate in the study
Key exclusion criteria (3 listed)
- Patient doesn't agree to participate in the study
- Dysplastic hip, Crowe>1
- After previous hip surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiographOne radiograph with the patient lying on his contralateral side | Other | Surgeon does see |
Primary outcome
acetabular cup angle
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiograph in people with Hip Osteoarthritis, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acetabular cup angle (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2011.