Rotator Cuff Tear ArthropathyNCT03111147
Impact of Humeral Component Version on Outcomes Following RTSA
A study testing 0 degrees humeral component version and 30 degrees humeral component retroversion in people with Rotator Cuff Tear Arthropathy, run by Corewell Health East at 1 site in United States.
Trial summary
The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear Arthropathy
- What is being tested?
- 0 degrees humeral component version and 30 degrees humeral component retroversion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2017to 23 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary reverse total shoulder arthroplasty
- Diagnosis of cuff tear arthropathy or primary OA with RCT
- Intact posterior rotator cuff and subscapularis preoperatively, as determined by surgeon-administered physical exam
- 18 years or older
Who cannot join
- Revision arthroplasty
- Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
- Minors (under 18 years of age)
- Prior open shoulder surgery
- Concomitant latissimus dorsi transfer
- Patients not undergoing a standard of care physical therapy protocol
- Pregnant, patient-reported
- Cognitively impaired
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Humeral Component Version on Outcomes Following Reverse Total Shoulder Arthroplasty: A Prospective Randomized Controlled Trial
The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.
Read the detailed description
Retrospective clinical evidence suggests that increasing humeral component retroversion does not affect measured internal or external rotation, however patients with neutral version may experience better function with daily activities requiring internal rotation compared to those with 30 degrees of retroversion. Prospective data on clinical outcomes comparing different humeral component versions in RTSA is currently lacking. The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.
- Conditions
- Rotator Cuff Tear Arthropathy
- Being tested
- 0 degrees humeral component version, 30 degrees humeral component retroversion
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 degrees humeral component versionDevice
RTSA with humeral component positioned in 0 degrees of version
30 degrees humeral component retroversionDevice
RTSA with humeral component positioned in 30 degrees of retroversion
| Study group | Role | What they receive |
|---|---|---|
| 0 degrees humeral component version | Experimental | Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version Receives: Device: 0 degrees humeral component version |
| 30 degrees humeral component retroversion | Experimental | Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion Receives: Device: 30 degrees humeral component retroversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative External Range of Motion (ROM)
External range of motion measurements of the shoulder in degrees
Measured: 2 years
Postoperative Internal Range of Motion (ROM)
Internal range of motion measurements of the shoulder in degrees
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start12 May 2017
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rotator Cuff Tear ArthropathyStudies 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Wiater, Corewell Health East
- Investigators
- J. Michael Wiater, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111147
- Sponsor's protocol ID
- 2017-057
- Status last verified
- Feb 2024
- First submitted
- 7 Apr 2017
- Last updated
- 5 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Humeral Component Version on Outcomes Following Reverse Total Shoulder Arthroplasty: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03111147
- Acronym / sponsor ID
- 2017-057
- Conditions
- Rotator Cuff Tear Arthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 5 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.
Detailed description
Retrospective clinical evidence suggests that increasing humeral component retroversion does not affect measured internal or external rotation, however patients with neutral version may experience better function with daily activities requiring internal rotation compared to those with 30 degrees of retroversion. Prospective data on clinical outcomes comparing different humeral component versions in RTSA is currently lacking. The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0 degrees humeral component version | Experimental | Device: 0 degrees humeral component versionReverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version |
| 30 degrees humeral component retroversion | Experimental | Device: 30 degrees humeral component retroversionReverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing primary reverse total shoulder arthroplasty
- Diagnosis of cuff tear arthropathy or primary OA with RCT
- Intact posterior rotator cuff and subscapularis preoperatively, as determined by surgeon-administered physical exam
- 18 years or older
Key exclusion criteria (8 listed)
- Revision arthroplasty
- Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
- Minors (under 18 years of age)
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 |
|---|---|---|
| 0 degrees humeral component versionRTSA with humeral component positioned in 0 degrees of version | Device | 0 degrees humeral component version |
| 30 degrees humeral component retroversionRTSA with humeral component positioned in 30 degrees of retroversion | Device | 30 degrees humeral component retroversion |
Primary outcome
Postoperative External Range of Motion (ROM)
Time frame: 2 years
External range of motion measurements of the shoulder in degrees
Postoperative Internal Range of Motion (ROM)
Time frame: 2 years
Internal range of motion measurements of the shoulder in degrees
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
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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.
J. Michael Wiater, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0 degrees humeral component version and 30 degrees humeral component retroversion in people with Rotator Cuff Tear Arthropathy, run by Corewell Health East at 1 site in United States.
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 4 inclusion and 8 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 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 5 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative External Range of Motion (ROM) (time frame: 2 years). The study lists 2 primary outcomes in all. 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 5 Mar 2024.