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

• ClinicalTrials.gov Identifier: NCT01539122
• Recruitment Status: Active, not recruiting
• First Posted: February 27, 2012
• Last Update Posted: February 15, 2019
• Sponsor: Joint Preservation Centre of BC
• Information provided by (Responsible Party): Patrick Chin, Joint Preservation Centre of BC

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis of the Shoulder	Device: Zimmer TM Glenoid; Device: Cemented Glenoid	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

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

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

• Responsible Party: Patrick Chin, Principal Investigator, Joint Preservation Centre of BC
• ClinicalTrials.gov Identifier: NCT01539122
• Other Study ID Numbers: TMGlenoid H12-00323
• First Posted: February 27, 2012
• Last Update Posted: February 15, 2019
• Last Verified: February 2019

Keywords provided by Patrick Chin, Joint Preservation Centre of BC:

osteoarthritis; shoulder replacement

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases