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

This study is not yet open for participant recruitment.
Verified February 2012 by Joint Preservation Centre of BC
Sponsor:
Information provided by (Responsible Party):
Joint Preservation Centre of BC
ClinicalTrials.gov Identifier:
NCT01539122
First received: February 13, 2012
Last updated: February 24, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Osteoarthritis of the Shoulder
 Device: Zimmer TM Glenoid
Device: Cemented Glenoid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Centre, Randomized Controlled Study on the Zimmer TM Glenoid Component Compared to Cemented Glenoid Component

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Joint Preservation Centre of BC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The WOOS will be done at 6 weeks, 3 months, 6 months and yearly post-op to compare with the baseline pre-op score.


Secondary Outcome Measures:
  • Change in ASES score [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr post-op ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Grashey A-P and axillary views to assess component position and radiolucency in 6 zones post op.


Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age - 18 years minimum and 80 years of age maximum.
  • Gender - male and female.
  • Primary Diagnosis: Primary Glenohumeral Osteoarthritis
  • Informed Consent - patient has signed a 'Patient Informed Consent form'
  • Surgery date: Beginning on January 1, 2012
  • KEY Inclusion Criteria: The critical inclusion criteria for patient selection for TM or Cemented glenoid prosthesis are based on adequacy of glenoid bone stock/quality at time of implantation. Pre-operative CT scans and intra-operative decision of the surgeon at time of surgery will determine the issue of bone stock/quality.

Exclusion Criteria:

  • Age > 80 years
  • Significant Bone Loss (classified as concentric vs eccentric; contained vs uncontained) on pre-operative CT scan requiring cemented prosthesis.
  • Evidence of major joint trauma, infection, avascular necrosis, cuff tear arthropathy, inflammatory arthropathy, chronic dislocation, massive rotator cuff tear or previous shoulder surgery (other than arthroscopic debridement)
  • Preoperative computed tomography scans of the shoulder that showed insufficient glenoid bone stock to allow for implantation of a glenoid prosthesis
  • Active joint or systematic infection, significant muscle paralysis, or Charcot arthropathy
  • Life expectancy of less than 2 years or unacceptably high operative risk
  • Inability to speak or read English
  • Psychiatric illness or cognitive deficit that precluded informed consent
  • Unwillingness to be followed up for 5 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539122

Contacts
Contact: Katrina Bruckschwaiger, BS, MPAS 604-827-5184 katrina.jpc@gmail.com

Locations
Canada, British Columbia
Royal Inland Hospital Not yet recruiting
Kamloops, British Columbia, Canada, V2C 2T1
Sub-Investigator: Derek Plausinis, MD, FRCS(C)            
University of British Columbia Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Contact: Katrina     604-827-5184     katrina.jpc@gmail.com    
Principal Investigator: Patrick Chin, MD,FRCSC,MBA            
Sub-Investigator: William Regan, MD, FRCS(C)            
Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1N1
Principal Investigator: Patrick Chin, MD,FRCSC,MBA            
Sub-Investigator: William Regan, MD, FRCS(C)            
Royal Jubilee Hospital Not yet recruiting
Victoria, British Columbia, Canada, V8R 1J8
Sub-Investigator: Zane Zarzour, MD, FRCS(C)            
Victoria General Hospital Not yet recruiting
Victoria, British Columbia, Canada, V8Z 6R5
Sub-Investigator: Zane Zarzour, MD, FRCS(C)            
Sponsors and Collaborators
Joint Preservation Centre of BC
Investigators
Principal Investigator: Patrick Chin, MD,FRCSC,MBA Joint Preservation Centre of BC/University of British Columbia
  More Information

No publications provided

Responsible Party: Joint Preservation Centre of BC
ClinicalTrials.gov Identifier: NCT01539122     History of Changes
Other Study ID Numbers: TMGlenoid H12-00323
Study First Received: February 13, 2012
Last Updated: February 24, 2012
Health Authority: Canada: Health Canada

Keywords provided by Joint Preservation Centre of BC:
osteoarthritis
shoulder replacement

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013