Does the Femoral Head Size Can Predict the Cup Size?

March 19, 2014 updated by: HaEmek Medical Center, Israel

Does the Femoral Head Size Can Predict the Cup Size? Retrospective Study.

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. To examine the absolute difference between the planned cup size diameter and the actual femoral head size diameter
  4. 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

Completed

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

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Afula, Israel, 18101
        • Orthopedic department, HaEmek medical center
      • Afula, Israel, 18101
        • HeEmek medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients that underwent primary Total hip arthroplasty due to end-stage primary osteoarthritis; Males and females between 15-90 years of age.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Total hip arthroplasty
are no specific Intervention
Other Names:
  • are no specific Intervention

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
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Estimate)

March 21, 2014

Last Update Submitted That Met QC Criteria

March 19, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 0067-13-EMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Total Hip Arthroplasty

Clinical Trials on There are no specific Intervention

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