Does the Femoral Head Size Can Predict the Cup Size?

NCT ID: NCT02093832

Last Updated: 2014-03-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 83 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-02-28

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..

Conditions

Total Hip Arthroplasty

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Total hip arthroplasty

There are no specific Intervention

Intervention Type: OTHER

are no specific Intervention

Interventions

There are no specific Intervention

are no specific Intervention

Intervention Type: OTHER

Other Intervention Names

are no specific Intervention

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HeEmek medical center

Afula, , Israel

Orthopedic department, HaEmek medical center

Afula, , Israel

Countries

Israel

Other Identifiers

0067-13-EMC

Identifier Type: -

Identifier Source: org_study_id