Does the Femoral Head Size Can Predict the Cup Size?

Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093832
• Other study ID #: 0067-13-EMC
• Status: Completed
• Phase: N/A
• First received: March 11, 2014
• Last updated: March 19, 2014
• Start date: July 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 90 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Other:
• There are no specific Intervention
are no specific Intervention

Locations

Country	Name	City	State
Israel	HeEmek medical center	Afula
Israel	Orthopedic department, HaEmek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To examine the absolute difference between the planned cup size diameter and the actual femoral head size diameter		up to one year	No
Primary	To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery.		up to one year	No
Secondary	To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter.		up to one year	No