Osteo Arthritis ShouldersrTSANCT03617107
Reverse Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing Reverse Total Shoulder Arthroplasty
An observational study of Osteo Arthritis Shoulders and Proximal Humeral Fracture, run by The Orthopaedic Research & Innovation Foundation at 1 site in United States.
Trial summary
The purpose of this study is to evaluate reverse total shoulder arthroplasty patients preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Shoulders, Proximal Humeral Fracture, Rotator Cuff Tear
- What is being tested?
- reverse total shoulder arthroplasty
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2017to 31 Dec 2020
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All eligible patients of principal investigator receiving rTSA for any indication at St. Elizabeth Healthcare between January 1, 2010 and October 31, 2017 will be evaluated and included in the data analysis.
Who may be able to join
- English speaking
- >18 years of age
- Reverse TSA performed by principal investigator
Who cannot join
- Non-English speaking
- <18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
The Orthopaedic Research & Innovation Foundation
Edgewood, Kentucky, 41017
About this study
The purpose of this study is to evaluate reverse total shoulder arthroplasty patients preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.
- Conditions
- Osteo Arthritis Shoulders, Proximal Humeral Fracture, Rotator Cuff Tear, Rotator Cuff Tear Arthropathy
- Being tested
- reverse total shoulder arthroplasty
- Medical subject headings
- Shoulder Fractures, Rotator Cuff Injuries, Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reverse total shoulder arthroplastyOther
reverse total shoulder arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
total operative time
minutes
Measured: preoperative to up to 8 years postoperative
amount of blood loss
mls
Measured: preoperative to up to 8 years postoperative
Secondary outcomes (2)
Patient Outcomes
American Shoulder and Elbow Surgeon score to measure shoulder function and pain. Scale of 0-100, 100 being the best possible score
Measured: preoperative to up to 8 years postoperative
Patient Outcomes
Simple Shoulder Test score to measure shoulder function. Scale from 0-12, 12 being the most functional.
Measured: preoperative to up to 8 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start15 Dec 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis ShouldersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Orthopaedic Research & Innovation Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- R M Greiwe, MD, Principal investigator, The Orthopaedic Research & Innovation Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617107
- Sponsor's protocol ID
- ORIF.004
- Acronym
- rTSA
- Status last verified
- Oct 2019
- First submitted
- 24 Jul 2018
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing Reverse Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT03617107
- Acronym / sponsor ID
- rTSA / ORIF.004
- Conditions
- Osteo Arthritis Shoulders, Proximal Humeral Fracture, Rotator Cuff Tear, Rotator Cuff Tear Arthropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Orthopaedic Research & Innovation FoundationUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 6 Aug 2018 (actual)
- 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 purpose of this study is to evaluate reverse total shoulder arthroplasty patients preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients of principal investigator receiving rTSA for any indication at St. Elizabeth Healthcare between January 1, 2010 and October 31, 2017 will be evaluated and included in the data analysis.
Key inclusion criteria (3 listed)
- English speaking
- >18 years of age
- Reverse TSA performed by principal investigator
Key exclusion criteria (2 listed)
- Non-English speaking
- <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 |
|---|---|---|
| reverse total shoulder arthroplastyreverse total shoulder arthroplasty | Other | – |
Primary outcome
total operative time
Time frame: preoperative to up to 8 years postoperative
minutes
amount of blood loss
Time frame: preoperative to up to 8 years postoperative
mls
2 secondary outcomes
Patient Outcomes
Time frame: preoperative to up to 8 years postoperative
Patient Outcomes
Time frame: preoperative to up to 8 years postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
R M Greiwe, MD principal investigator
The Orthopaedic Research & Innovation Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteo Arthritis Shoulders and Proximal Humeral Fracture, run by The Orthopaedic Research & Innovation Foundation 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 3 inclusion and 2 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 25 Oct 2019. 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?
Results are not available in the source record.
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?
total operative time (time frame: preoperative to up to 8 years postoperative). 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 25 Oct 2019.