- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02093832
Does the Femoral Head Size Can Predict the Cup Size?
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Afula, Israel, 18101
- Orthopedic department, HaEmek medical center
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Afula, Israel, 18101
- HeEmek medical center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients that underwent primary Total hip arthroplasty due to end-stage primary osteoarthritis;
Exclusion Criteria:
- Significant distortion in the femoral head.
- Previous reconstructive surgery - radial osteotomy and hip socket.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Total hip arthroplasty
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are no specific Intervention
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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up to one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter.
Time Frame: up to one year
|
up to one year
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To examine the absolute difference between the planned cup size diameter and the actual femoral head size diameter
Time Frame: up to one year
|
up to one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0067-13-EMC
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