NCT02220478

Signature Acetabular Posterior/Lateral Data Collection

A Prospective Controlled Study on Signature Anterior Posterior/Lateral Acetabular Cup Placement System in Total Hip Arthroplasty

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this pilot study is to evaluate the accuracy of cup placement between two instrumentation technologies: Cutting Guide and Conventional Instrumentation.

Detailed description

Using a more advanced surgical technique may assist surgeons and patients in a variety of ways including identifying a specific-size for the prosthesis prior to surgery, increasing operating room efficiency, and reducing the number of traditional instruments needed. This may reduce cost associated with the instrument inventory and instrument sterilization. Operating time may also be reduced, potentially decreasing the patient's risk of infection. However, before these hypotheses can be tested, it is important to fully understand the efficacy and accuracy of Signature Custom Guides and their use in Total Hip Arthroplasty.

Conditions

• Noninflammatory Degenerative Joint Disease
• Avascular Necrosis
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	Posterior Lateral Approach Total Hip Arthroplasty	All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2014-08-20
• Last updated: 2022-10-25
• Results posted: 2022-10-25