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Completed

NCT Number: NCT02093832

Does the Femoral Head Size Can Predict the Cup Size?

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.

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Key information

Conditions

Total Hip Arthroplasty

Age range

15 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HeEmek medical center, Afula, Israel

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About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

There are no specific Intervention

Other

are no specific Intervention

Other names: are no specific Intervention

Primary outcomes

  1. 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

Secondary outcomes

  1. To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter.

    Time frame: up to one year

Other outcomes

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

    Time frame: up to one year

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 21, 2014
Registry last updated
Mar 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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