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

NCT01539122 | Completed

• 1 other identifier: TMGlenoid H12-00323
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 6

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.

Conditions

Osteoarthritis of the Shoulder

Keywords

osteoarthritis; shoulder replacement

Outcome Measures

Primary Outcomes (1)

• Change in Western Ontario Arthritis of the Shoulder Index (WOOS)

  The WOOS will be done at 6 weeks, 3 months, 6 months and yearly post-op to compare with the baseline pre-op score.

  6 weeks, 3 mo, 6 mo, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr post-op

Secondary Outcomes (4)

• Change in ASES score

  6 weeks, 3 mo, 6 mo, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr post-op

• Change in Short Form 12 (SF-12)

  6 weeks, 3 mo, 6 mo, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr post-op

• Change in Health Resource Utilization Instrument

  6 weeks, 3 mo, 6 mo, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr post-op

• Change in Radiographic evaluation

  post-op day 0 or 1, 6 weeks, 3 months, 6 months, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr post-op

Study Arms (2)

TM Glenoid

ACTIVE COMPARATOR

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

Device: Zimmer TM Glenoid

Cemented Glenoid

ACTIVE COMPARATOR

Cemented glenoid shoulder replacement component

Device: Cemented Glenoid

Interventions

Zimmer TM Glenoid DEVICE

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

Also known as: Zimmer Trabecular Metal Glenoid

TM Glenoid

Cemented Glenoid DEVICE

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

Also known as: Cemented all-polyethylene glenoid component (Zimmer)

Cemented Glenoid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joint Preservation Centre of BC: lead

Study Sites (6)

Kelowna General Hospital

Kelowna, British Columbia, Canada

Location

Richmond General Hospital

Richmond, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1N1, Canada

Location

University of British Columbia Hospital

Vancouver, British Columbia, V6T 2B5, Canada

Location

Royal Jubilee Hospital

Victoria, British Columbia, V8R 1J8, Canada

Location

Victoria General Hospital

Victoria, British Columbia, V8Z 6R5, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Patrick Chin, MD,FRCSC,MBA

  Joint Preservation Centre of BC/University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: February 27, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 2, 2023

Record last verified: 2023-07

Locations

CA (6)