Does the Femoral Head Size Can Predict the Cup Size?

NCT02093832 | Completed DMC

• 1 other identifier: 0067-13-EMC
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 2

Brief Summary

This study had four aims:

1. 1.To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery.
2. 2.To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter.
3. 3.To examine the absolute difference between the planned cup size diameter and the actual femoral head size diameter
4. 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.

Conditions

Total Hip Arthroplasty

Keywords

femoral head size; cup size; Total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  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

  up to one year

Study Arms (1)

Total hip arthroplasty

Other: There are no specific Intervention

Interventions

There are no specific Intervention OTHER

are no specific Intervention

Also known as: are no specific Intervention

Total hip arthroplasty

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients that underwent primary Total hip arthroplasty due to end-stage primary osteoarthritis;

You may not qualify if:

• Significant distortion in the femoral head.
• Previous reconstructive surgery - radial osteotomy and hip socket.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (2)

HeEmek medical center

Afula, 18101, Israel

Location

Orthopedic department, HaEmek medical center

Afula, 18101, Israel

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 21, 2014
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 21, 2014

Record last verified: 2014-03

Locations

IL (2)