Total Hip ArthroplastyNCT02093832
Does the Femoral Head Size Can Predict the Cup Size?
An observational study of Total Hip Arthroplasty, run by HaEmek Medical Center, Israel at 2 sites in Israel.
Trial summary
This study had four aims: 1. To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery. 2. To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter. 3. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- There are no specific Intervention
- How many people
- 83 participants
- Where
- 2 sitesIsrael
- Study dates
- Jul 2013to Feb 2014
- Phase
- Observational
- 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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that underwent primary Total hip arthroplasty due to end-stage primary osteoarthritis; Males and females between 15-90 years of age.
Who may be able to join
- Patients that underwent primary Total hip arthroplasty due to end-stage primary osteoarthritis;
Who cannot join
- Significant distortion in the femoral head.
- Previous reconstructive surgery - radial osteotomy and hip socket.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
HeEmek medical center
Afula, 18101
Orthopedic department, HaEmek medical center
Afula, 18101
About this study
Official title: Does the Femoral Head Size Can Predict the Cup Size? Retrospective Study.
This study had four aims:
- To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery.
- To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter.
- To examine the absolute difference between the planned cup size diameter and the actual femoral head size diameter
- To suggest an additional online monitoring tool on the accuracy of the preoperative process and implant selection. We hypothesized that high accuracy rates will be found between the preoperative planned cup size and the actual implanted cup size. Furthermore, we hypothesized that strong correlations will be found between the planned and actual implanted cup size and the actual femoral head diameter size.
Read the detailed description
Methods This is a retrospective study , that will include patients who underwent primary cementless THA due to end-stage hip osteoarthritis during 2011 and 2013 . Inclusion criteria were: Patients that underwent primary THA due to end-stage primary osteoarthritis; Males and females between 15-90 years of age.
Data collection The following data will be collected: patients' characteristic including gender, age at surgery and side of surgery; implant information including cup model, planed cup size, actual cup size, shell type and outer diameter size (mm); actual femoral head diameter size (mm); the difference between the planned cup size and the actual cup size that was used; the difference between the actual femoral head diameter size measured at the end of surgery and the cementless implanted cup outer diameter size; the difference between the actual femoral head diameter size and the planed cup size..
- Conditions
- Total Hip Arthroplasty
- Being tested
- There are no specific Intervention
- Keywords
- femoral head size, cup size, Total hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There are no specific InterventionOther
Also called are no specific Intervention
are no specific Intervention
| Study group | Role | What they receive |
|---|---|---|
| Total hip arthroplasty | Not described Receives: Other: There are no specific Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery.
Measured: up to one year
Secondary outcomes (1)
To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter.
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093832
- Sponsor's protocol ID
- 0067-13-EMC
- Status last verified
- Mar 2014
- First submitted
- 11 Mar 2014
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Femoral Head Size Can Predict the Cup Size? Retrospective Study.
- ClinicalTrials.gov ID
- NCT02093832
- Acronym / sponsor ID
- 0067-13-EMC
- Conditions
- Total Hip Arthroplasty
- Keywords
- femoral head size, cup size, Total hip arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Mar 2014 (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.
This study had four aims:
- To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery.
- To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter.
- To examine the absolute difference between the planned cup size diameter and the actual femoral head size diameter
- To suggest an additional online monitoring tool on the accuracy of the preoperative process and implant selection. We hypothesized that high accuracy rates will be found between the preoperative planned cup size and the actual implanted cup size. Furthermore, we hypothesized that strong correlations will be found between the planned and actual implanted cup size and the actual femoral head diameter size.
Detailed description
Methods This is a retrospective study , that will include patients who underwent primary cementless THA due to end-stage hip osteoarthritis during 2011 and 2013 . Inclusion criteria were: Patients that underwent primary THA due to end-stage primary osteoarthritis; Males and females between 15-90 years of age.
Data collection The following data will be collected: patients' characteristic including gender, age at surgery and side of surgery; implant information including cup model, planed cup size, actual cup size, shell type and outer diameter size (mm); actual femoral head diameter size (mm); the difference between the planned cup size and the actual cup size that was used; the difference between the actual femoral head diameter size measured at the end of surgery and the cementless implanted cup outer diameter size; the difference between the actual femoral head diameter size and the planed cup size..
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total hip arthroplasty | – | Other: There are no specific Intervention |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that underwent primary Total hip arthroplasty due to end-stage primary osteoarthritis; Males and females between 15-90 years of age.
Key inclusion criteria (1 listed)
- Patients that underwent primary Total hip arthroplasty due to end-stage primary osteoarthritis;
Key exclusion criteria (2 listed)
- Significant distortion in the femoral head.
- Previous reconstructive surgery - radial osteotomy and hip socket.
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 |
|---|---|---|
| There are no specific InterventionAlso: are no specific Interventionare no specific Intervention | Other | Total hip arthroplasty |
Primary outcome
To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery.
Time frame: up to one year
1 secondary outcome
To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter.
Time frame: up to one year
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 21 Mar 2014.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty, run by HaEmek Medical Center, Israel at 2 sites 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 1 inclusion and 2 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 21 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery. (time frame: up to one year). 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 21 Mar 2014.