Clinical Experience With the Zimmer Trabecular Metal (TM) Glenoid in Total Shoulder Arthroplasty (TMGlenoid)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01539122|
Recruitment Status : Active, not recruiting
First Posted : February 27, 2012
Last Update Posted : March 20, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of the Shoulder||Device: Zimmer TM Glenoid Device: Cemented Glenoid||Not Applicable|
Total shoulder arthroplasty is successful in relieving pain and restoring function to the joint, but chronic loosening of the glenoid implant remains a common complication. The Zimmer Trabecular Metal (TM) Glenoid is a monoblock implant for reconstructive total shoulder arthroplasty. To date, no published clinical data is available to confirm evidence on the effectiveness of this specific product.
The purpose of this prospective study is to obtain both short and long-term clinical outcomes data on the Zimmer TM Glenoid by analysis of standard scoring systems and radiographic analysis. The TM Glenoid Component is intended to function within Zimmer, Inc.'s Bigliani/Flatow (B/F) Complete Shoulder Solution. The device is a monoblock glenoid component comprised of a Trabecular Metal base, and is designed to interface and articulate with Zimmer, Inc.'s B/F humeral components. The Trabecular Metal Glenoid is designed with an articular surface that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The base of the implant has a cruciate TM keel that provides stability and initial fixation using a press-fit between the implant and the bone. Long-term fixation is provided by biological ingrowth into the TM material. Surgical fixation of the trabecular metal device will be obtained via press-fit. Surgical fixation of the comparison all-polyethylene glenoid component will be with Palacos/CoPal bone cement
This is a multi-centre, randomized controlled study to evaluate the clinical and radiological performance of the TM Glenoid in a series of patients with adequate glenoid bone stock receiving a total shoulder replacement. The comparison group will be a consecutive series of randomized patients with implanted cemented all-polyethylene glenoid component. This study will be descriptive in nature and seeks to demonstrate the superiority (or non-inferiority) of the TM Glenoid over cemented all-polyethylene glenoid components.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Centre, Randomized Controlled Study on the Zimmer TM Glenoid Component Compared to Cemented Glenoid Component|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||June 2022|
Active Comparator: TM Glenoid
Zimmer TM glenoid shoulder replacement component will be used for the glenoid component of the total shoulder replacement.
Device: Zimmer TM Glenoid
The Zimmer TM glenoid will be used for the glenoid shoulder replacement component.
Other Name: Zimmer Trabecular Metal Glenoid
Active Comparator: Cemented Glenoid
Cemented glenoid shoulder replacement component
Device: Cemented Glenoid
A cemented glenoid will be used for the glenoid component of the total shoulder replacement.
Other Name: Cemented all-polyethylene glenoid component (Zimmer)
- Change in Western Ontario Arthritis of the Shoulder Index (WOOS) [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr post-op ]The WOOS will be done at 6 weeks, 3 months, 6 months and yearly post-op to compare with the baseline pre-op score.
- Change in ASES score [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr post-op ]The ASES will be done at 6 weeks, 3 months, 6 months and yearly post-op to compare with the baseline pre-op score.
- Change in Short Form 12 (SF-12) [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr post-op ]The SF-12 will be done at 6 weeks, 3 months, 6 months and yearly post-op to compare with the baseline pre-op score.
- Change in Health Resource Utilization Instrument [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr post-op ]The Health Resource Utilization Instrument will be done at 6 weeks, 3 months, 6 months and yearly post-op to gather data on the associated costs of the respective surgeries.
- Change in Radiographic evaluation [ Time Frame: post-op day 0 or 1, 6 weeks, 3 months, 6 months, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr post-op ]Grashey A-P and axillary views to assess component position, metallic debris, and radiolucency in 6 zones post op.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539122
|Canada, British Columbia|
|Kelowna General Hospital|
|Kelowna, British Columbia, Canada|
|Richmond General Hospital|
|Richmond, British Columbia, Canada|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z 1N1|
|University of British Columbia Hospital|
|Vancouver, British Columbia, Canada, V6T 2B5|
|Royal Jubilee Hospital|
|Victoria, British Columbia, Canada, V8R 1J8|
|Victoria General Hospital|
|Victoria, British Columbia, Canada, V8Z 6R5|
|Principal Investigator:||Patrick Chin, MD,FRCSC,MBA||Joint Preservation Centre of BC/University of British Columbia|