Does the Femoral Head Size Can Predict the Cup Size?

Completed

• Conditions: Total Hip Arthroplasty
• Interventions: Other: There are no specific Intervention

• Registration Number: NCT02093832
• Lead Sponsor: HaEmek Medical Center, Israel

Brief 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. 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.

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 Timeline

• Study Start: 2013-07
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-03
• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-03-19
• Last Update Submitted: 2014-03-19
• Study First Posted: 2014-03-21
• Last Update Posted: 2014-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total hip arthroplasty	There are no specific Intervention	-

Primary Outcome Measures

Name	Time	Method
To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery.	up to one year

Secondary Outcome Measures

Name	Time	Method
To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter.	up to one year

Trial Locations

Locations (2)

HeEmek medical center; 🇮🇱 Afula, Israel

Orthopedic department, HaEmek medical center; 🇮🇱 Afula, Israel