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Clinical Experience With the Zimmer Trabecular Metal (TM) Glenoid in Total Shoulder Arthroplasty

NCT01539122 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2023-08-02

No results posted yet for this study

Summary

The objective of this randomized controlled study is to obtain outcomes data on the Zimmer TM glenoid component by analysis of standard scoring systems and radiographs in comparison to the cemented glenoid component. In addition, the investigators plan to provide cost analysis based on the economic data collected to justify the cost difference between both implants.

Patients with acceptable glenoid bone stock will be randomized into two groups to be treated with either a TM Glenoid or cemented glenoid component with minimum 2 years follow-up; maximum 10 years follow-up.

Hypothesis: The early and long-term clinical outcomes and radiographic analysis of the TM glenoid components are superior to the cemented glenoid components in total shoulder arthroplasty patients.

Conditions

  • Osteoarthritis of the Shoulder

Interventions

DEVICE

Zimmer TM Glenoid

The Zimmer TM glenoid will be used for the glenoid shoulder replacement component.

DEVICE

Cemented Glenoid

A cemented glenoid will be used for the glenoid component of the total shoulder replacement.

Sponsors & Collaborators

  • Joint Preservation Centre of BC

    lead OTHER

Principal Investigators

  • Patrick Chin, MD,FRCSC,MBA · Joint Preservation Centre of BC/University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Canada

Study Locations

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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 NCT01539122 on ClinicalTrials.gov