NCT01763684

Oxford Signature vs. Conventional Global Study

A Global Comparison of Signature Guides and Conventional Instrumentation in the Oxford Partial Knee

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study will compare alignment criteria in the Oxford Partial Knee using conventional instrumentation and Signature Custom Guides in order to determine if the use of the Signature Custom Guides results in a higher percentage of knees achieving optimal alignment. The study will also examine outcomes with high volume surgeons (\>30 cases/year) and low volume surgeons (\<10 cases/year).

Detailed description

The primary objectives of this global clinical study are to collect data to assess the following clinical evidence parameters that were gathered from Biomet team members and KOL globally for this product: 1. Evaluate the performance \& accuracy of the Oxford Partial Knee System with Signature Knee Guide in comparison to conventional instrumentation. 2. Compare the accuracy of Signature Guides between two user profiles: high volume surgeons \& low volume surgeons in a global mix. 3. Assess potential economic \& efficiency advantages in the short term and long-term: OR efficiency, patient quality of life and activity, clinical outcomes.

Conditions

• Osteoarthritis
• Osteoarthritis, Knee
• Osteonecrosis

Interventions

Type	Name	Description
DEVICE	Signature Custom Guides	Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
PROCEDURE	Conventional Instrumentation	Traditional partial knee arthroplasty without the use of Signature technology.

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2013-01-09
• Last updated: 2021-04-23
• Results posted: 2021-04-23

Locations

7 sites across 1 country: United States