Clinical Experience With the Zimmer Trabecular Metal (TM) Glenoid in Total Shoulder Arthroplasty
Condition: Osteoarthritis of the Shoulder
MeSH terms: Osteoarthritis
Study type: Interventional

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.
    

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.
    

Intervention name(s): Zimmer TM Glenoid; Cemented Glenoid
Intervention type(s): Device; Device
Intervention description(s): The Zimmer TM glenoid will be used for the glenoid shoulder replacement component.; A cemented glenoid will be used for the glenoid component of the total shoulder replacement.
Other intervention name(s): Zimmer Trabecular Metal Glenoid; Cemented all-polyethylene glenoid component (Zimmer)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: osteoarthritis; shoulder replacement