Osteoarthritis of the ShoulderTMGlenoidNCT01539122
Clinical Experience With the Zimmer Trabecular Metal (TM) Glenoid in Total Shoulder Arthroplasty
A study testing Zimmer TM Glenoid and Cemented Glenoid in people with Osteoarthritis of the Shoulder, run by Joint Preservation Centre of BC at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis of the Shoulder
- What is being tested?
- Zimmer TM Glenoid and Cemented Glenoid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 6 sitesCanada
- Study dates
- Apr 2012to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Inability to speak or read English
- Psychiatric illness or cognitive deficit that precluded informed consent
- Unwillingness to be followed up for 5 years
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Kelowna General Hospital
Kelowna, British Columbia
Richmond General Hospital
Richmond, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1N1
University of British Columbia Hospital
Vancouver, British Columbia, V6T 2B5
Royal Jubilee Hospital
Victoria, British Columbia, V8R 1J8
Victoria General Hospital
Victoria, British Columbia, V8Z 6R5
About this study
Official title: A Multi-Centre, Randomized Controlled Study on the Zimmer TM Glenoid Component Compared to Cemented Glenoid Component
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.
Read the 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.
- Conditions
- Osteoarthritis of the Shoulder
- Being tested
- Zimmer TM Glenoid, Cemented Glenoid
- Keywords
- osteoarthritis, shoulder replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimmer TM GlenoidDevice
Also called Zimmer Trabecular Metal Glenoid
The Zimmer TM glenoid will be used for the glenoid shoulder replacement component.
Cemented GlenoidDevice
Also called Cemented all-polyethylene glenoid component (Zimmer)
A cemented glenoid will be used for the glenoid component of the total shoulder replacement.
| Study group | Role | What they receive |
|---|---|---|
| TM Glenoid | Active comparator | Zimmer TM glenoid shoulder replacement component will be used for the glenoid component of the total shoulder replacement. Receives: Device: Zimmer TM Glenoid |
| Cemented Glenoid | Active comparator | Cemented glenoid shoulder replacement component Receives: Device: Cemented Glenoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The ASES will be done at 6 weeks, 3 months, 6 months and yearly post-op to compare with the baseline pre-op score.
Measured: 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)
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.
Measured: 6 weeks, 3 mo, 6 mo, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr post-op
Change in Health Resource Utilization Instrument
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.
Measured: 6 weeks, 3 mo, 6 mo, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr post-op
Change in Radiographic evaluation
Grashey A-P and axillary views to assess component position, metallic debris, and radiolucency in 6 zones post op.
Measured: post-op day 0 or 1, 6 weeks, 3 months, 6 months, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joint Preservation Centre of BC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Chin, Joint Preservation Centre of BC
- Investigators
- Patrick Chin, MD,FRCSC,MBA, Principal investigator, Joint Preservation Centre of BC/University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539122
- Sponsor's protocol ID
- TMGlenoid H12-00323
- Acronym
- TMGlenoid
- Status last verified
- Jul 2023
- First submitted
- 13 Feb 2012
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Randomized Controlled Study on the Zimmer TM Glenoid Component Compared to Cemented Glenoid Component
- ClinicalTrials.gov ID
- NCT01539122
- Acronym / sponsor ID
- TMGlenoid / TMGlenoid H12-00323
- Conditions
- Osteoarthritis of the Shoulder
- Keywords
- osteoarthritis, shoulder replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Joint Preservation Centre of BCUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TM Glenoid | Active comparator | Device: Zimmer TM GlenoidZimmer TM glenoid shoulder replacement component will be used for the glenoid component of the total shoulder replacement. |
| Cemented Glenoid | Active comparator | Device: Cemented GlenoidCemented glenoid shoulder replacement component |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zimmer TM GlenoidAlso: Zimmer Trabecular Metal GlenoidThe Zimmer TM glenoid will be used for the glenoid shoulder replacement component. | Device | TM Glenoid |
| Cemented GlenoidAlso: Cemented all-polyethylene glenoid component (Zimmer)A cemented glenoid will be used for the glenoid component of the total shoulder replacement. | Device | Cemented Glenoid |
Primary outcome
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.
4 secondary outcomes
Change in ASES score
Time frame: 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)
Time frame: 6 weeks, 3 mo, 6 mo, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr post-op
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Chin, MD,FRCSC,MBA principal investigator
Joint Preservation Centre of BC/University of British Columbia
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zimmer TM Glenoid and Cemented Glenoid in people with Osteoarthritis of the Shoulder, run by Joint Preservation Centre of BC at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.