ArthritisPhase 3NCT02305966
Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty
A Phase 3 study testing surgery and 0.8 mm diameter Tantalum marker beads in people with Arthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
Reverse total shoulder replacement surgery (RTSA) is performed for individuals with advanced arthritis of the shoulder who also have tears in their rotator cuff muscles. A metal hemisphere is placed in the shoulder blade, and a plastic cup on a stem is placed in the upper arm. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Arthritis
- What is being tested?
- surgery and 0.8 mm diameter Tantalum marker beads
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to Nov 2019
- Phase
- Phase 3
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- will be any patient with cuff tear arthropathy requiring reverse shoulder arthroplasty.
Who cannot join
- will be any patient with a previous RTSA or TSA (i.e. no revision surgery) or anyone unable to return for RSA imaging (e.g. living >100 km outside of London).
Trial locations and contacts
No sites are listed yet.
About this study
Reverse total shoulder replacement surgery (RTSA) is performed for individuals with advanced arthritis of the shoulder who also have tears in their rotator cuff muscles. A metal hemisphere is placed in the shoulder blade, and a plastic cup on a stem is placed in the upper arm. This orientation is opposite to the normal anatomy, giving rise to the term "reverse" shoulder replacement. While RTSA has a good clinical track record, no studies have examined how well fixed the implanted components are within patients.
- Conditions
- Arthritis
- Being tested
- surgery, 0.8 mm diameter Tantalum marker beads
- Keywords
- advanced arthritis, shoulder
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
All patients will receive a Delta XTEND reverse shoulder implant
0.8 mm diameter Tantalum marker beadsDevice
At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant,
| Study group | Role | What they receive |
|---|---|---|
| pressfit humerus & non-lateralized glenoid | Active comparator | All patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented). Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component.Therefore, 4 randomization groups will be created and one of them is -pressfit humerus \& non-lateralized glenoid. Receives: Procedure: surgery; Device: 0.8 mm diameter Tantalum marker beads |
| pressfit humerus & lateralized glenoid | Active comparator | All patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented). Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component.Therefore, 4 randomization groups will be created and one of them is - pressfit humerus \& lateralized glenoid. Receives: Procedure: surgery; Device: 0.8 mm diameter Tantalum marker beads |
| cemented humerus & non-lateralized glenoid | Active comparator | All patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented).Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component. Therefore, 4 randomization groups will be created and one of them is cemented humerus \& non-lateralized glenoid Receives: Procedure: surgery; Device: 0.8 mm diameter Tantalum marker beads |
| cemented humerus & lateralized glenoid. | Active comparator | All patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented).Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component.Therefore, 4 randomization groups will be created and one of them is cemented humerus \& lateralized glenoid. Receives: Procedure: surgery; Device: 0.8 mm diameter Tantalum marker beads |
What is being measured
The primary outcome is the main question the study is designed to answer.
migration between cemented and press-fit RTSA humeral components detected by Radiostereometric analysis
Measured: 24 months
Secondary outcomes (1)
difference in component migration between conventional and lateralized glenoid components detected by Radiostereometric analysis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study start1 Aug 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Athwal, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305966
- Sponsor's protocol ID
- 7519
- Status last verified
- Mar 2017
- First submitted
- 30 Oct 2014
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT02305966
- Acronym / sponsor ID
- 7519
- Conditions
- Arthritis
- Keywords
- advanced arthritis, shoulder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 3 Dec 2014 (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.
Reverse total shoulder replacement surgery (RTSA) is performed for individuals with advanced arthritis of the shoulder who also have tears in their rotator cuff muscles. A metal hemisphere is placed in the shoulder blade, and a plastic cup on a stem is placed in the upper arm. This orientation is opposite to the normal anatomy, giving rise to the term "reverse" shoulder replacement. While RTSA has a good clinical track record, no studies have examined how well fixed the implanted components are within patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| pressfit humerus & non-lateralized glenoid | Active comparator | Procedure: surgery, Device: 0.8 mm diameter Tantalum marker beadsAll patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented). Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component.Therefore, 4 randomization groups will be created and one of them is -pressfit humerus \& non-lateralized glenoid. |
| pressfit humerus & lateralized glenoid | Active comparator | Procedure: surgery, Device: 0.8 mm diameter Tantalum marker beadsAll patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented). Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component.Therefore, 4 randomization groups will be created and one of them is - pressfit humerus \& lateralized glenoid. |
| cemented humerus & non-lateralized glenoid | Active comparator | Procedure: surgery, Device: 0.8 mm diameter Tantalum marker beadsAll patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented).Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component. Therefore, 4 randomization groups will be created and one of them is cemented humerus \& non-lateralized glenoid |
| cemented humerus & lateralized glenoid. | Active comparator | Procedure: surgery, Device: 0.8 mm diameter Tantalum marker beadsAll patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented).Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component.Therefore, 4 randomization groups will be created and one of them is cemented humerus \& lateralized glenoid. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- will be any patient with cuff tear arthropathy requiring reverse shoulder arthroplasty.
Key exclusion criteria (1 listed)
- will be any patient with a previous RTSA or TSA (i.e. no revision surgery) or anyone unable to return for RSA imaging (e.g. living >100 km outside of London).
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 |
|---|---|---|
| surgeryAll patients will receive a Delta XTEND reverse shoulder implant | Procedure or surgery | cemented humerus & lateralized glenoid., cemented humerus & non-lateralized glenoid, pressfit humerus & lateralized glenoid, pressfit humerus & non-lateralized glenoid |
| 0.8 mm diameter Tantalum marker beadsAt the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, | Device | cemented humerus & lateralized glenoid., cemented humerus & non-lateralized glenoid, pressfit humerus & lateralized glenoid, pressfit humerus & non-lateralized glenoid |
Primary outcome
migration between cemented and press-fit RTSA humeral components detected by Radiostereometric analysis
Time frame: 24 months
1 secondary outcome
difference in component migration between conventional and lateralized glenoid components detected by Radiostereometric analysis
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing surgery and 0.8 mm diameter Tantalum marker beads in people with Arthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kate Kelly, M.Sc,MPH/Gero (519-646-6100 ext. 64640, Kate.Kelly@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
migration between cemented and press-fit RTSA humeral components detected by Radiostereometric analysis (time frame: 24 months). 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 24 Mar 2017.