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Oxford Signature vs. Conventional Global Study

NCT01763684 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2021-04-23

Study results available
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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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Russell Schenck, Ph.D. · Zimmer Biomet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01763684 on ClinicalTrials.gov