Total Shoulder ArthoplastyNCT04827277
TSA Versus RSA in Patients >75
A study testing Reverse Total Shoulder Replacement and Anatomic Total Shoulder Replacement in people with Total Shoulder Arthoplasty, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Total shoulder arthroplasty (TSA) has proven to be a predictable and successful operation for the treatment of symptomatic glenohumeral osteoarthritis (GHOA) with an intact rotator cuff. Results after TSA have not been as good in cases with rotator cuff dysfunction, however. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Shoulder Arthoplasty
- What is being tested?
- Reverse Total Shoulder Replacement and Anatomic Total Shoulder Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 15 Apr 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- All patients (75 years of age) at the time of surgery
- Patient is willing to participate by complying with pre and postoperative visit requirements
- Patient is willing to consent for enrollment
- Patient has advanced imaging (CT or MRI) that demonstrates an intact rotator cuff
Who cannot join
- Patients under the age of 75
- Need for any structural graft for repair of the shoulder during surgery
- Current infection of the proximal humerus or scapula
- Proximal humerus fracture
- Inadequate or malformed bone that precludes adequate support for prosthesis (B2, B3, C Glenoid morphology)
- Neuromuscular disorder that does not allow control of the shoulder joint
Show all 15Show fewer
- Significant injury to the brachial plexus
- Diagnosis of inflammatory arthropathy
- Preoperative diagnosis of full thickness rotator cuff tear
- >Goutallier Stage 1 rotator cuff atrophy
- Prior shoulder arthroplasty
- Non-functioning deltoid muscle
- Patients who are known drug or alcohol abuser, or have a psychological disorder as defined by the DSM4 that could affect follow-up care
- Patient is a prisoner
- Patients who are currently involved in any personal injury litigation, or worker's compensation claims.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Prospective Randomized Clinical Trial Comparing Total Shoulder Arthroplasty vs Reverse Shoulder Arthroplasty in Patients >75 Years of Age
Total shoulder arthroplasty (TSA) has proven to be a predictable and successful operation for the treatment of symptomatic glenohumeral osteoarthritis (GHOA) with an intact rotator cuff. Results after TSA have not been as good in cases with rotator cuff dysfunction, however. Early glenoid loosening, shoulder pain and the need for revision surgery has been all associated with rotator cuff deficiency. Even in cases without tears, fatty infiltration of the rotator cuff has been associated with inferior outcomes in TSA.
Advanced age has been shown to be associated with increased fatty infiltration of the rotator cuff in shoulders with primary osteoarthritis. Because of this, one may propose that surgeons should avoid the potential complications with TSA and perform RSA for patients with advanced age. It is thus the purpose of this study to evaluate the patient reported outcomes (PROs) of total shoulder arthroplasty (TSA) compared with reverse shoulder arthroplasty (RSA) in patients >75 years of age
- Conditions
- Total Shoulder Arthoplasty
- Being tested
- Reverse Total Shoulder Replacement, Anatomic Total Shoulder Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse Total Shoulder ReplacementProcedure or surgery
Participants will be randomized to a reverse total shoulder replacement
Anatomic Total Shoulder ReplacementProcedure or surgery
Participants will be randomized to an anatomic total shoulder replacement
| Study group | Role | What they receive |
|---|---|---|
| Reverse total shoulder replacement | Active comparator | Participants will receive a reverse total shoulder arthroplasty Receives: Procedure: Reverse Total Shoulder Replacement |
| Anatomic total shoulder replacement | Active comparator | Participants will receive an anatomic total shoulder arthroplasty Receives: Procedure: Anatomic Total Shoulder Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative satisfaction
Investigators will be measuring whether there is an increase in participants satisfaction after surgery as assessed by the American Shoulder and Elbow Score (ASES)
Measured: 2 years
Postoperative Satisfaction
Investigators will be measuring whether there is an increase in participants satisfaction after surgery as assessed by the Simple Shoulder Test (SST)
Measured: 2 years
Postoperative Pain
Investigators will be measuring whether there is an increase in participants satisfaction after surgery as assessed by the Visual Analog Scale (VAS)
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 posted1 Apr 2021
- Study start15 Apr 2021 (estimated)
- Primary completion15 Apr 2022 (estimated)
- Study completion15 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Shoulder ArthoplastyStudies 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
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827277
- Sponsor's protocol ID
- JABB20D.949
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial Comparing Total Shoulder Arthroplasty vs Reverse Shoulder Arthroplasty in Patients >75 Years of Age
- ClinicalTrials.gov ID
- NCT04827277
- Acronym / sponsor ID
- JABB20D.949
- Conditions
- Total Shoulder Arthoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 15 Apr 2021 (estimated)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 15 Apr 2022 (estimated)
- First posted
- 1 Apr 2021 (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.
Total shoulder arthroplasty (TSA) has proven to be a predictable and successful operation for the treatment of symptomatic glenohumeral osteoarthritis (GHOA) with an intact rotator cuff. Results after TSA have not been as good in cases with rotator cuff dysfunction, however. Early glenoid loosening, shoulder pain and the need for revision surgery has been all associated with rotator cuff deficiency. Even in cases without tears, fatty infiltration of the rotator cuff has been associated with inferior outcomes in TSA.
Advanced age has been shown to be associated with increased fatty infiltration of the rotator cuff in shoulders with primary osteoarthritis. Because of this, one may propose that surgeons should avoid the potential complications with TSA and perform RSA for patients with advanced age. It is thus the purpose of this study to evaluate the patient reported outcomes (PROs) of total shoulder arthroplasty (TSA) compared with reverse shoulder arthroplasty (RSA) in patients >75 years of age
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reverse total shoulder replacement | Active comparator | Procedure: Reverse Total Shoulder ReplacementParticipants will receive a reverse total shoulder arthroplasty |
| Anatomic total shoulder replacement | Active comparator | Procedure: Anatomic Total Shoulder ReplacementParticipants will receive an anatomic total shoulder arthroplasty |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- All patients (75 years of age) at the time of surgery
- Patient is willing to participate by complying with pre and postoperative visit requirements
- Patient is willing to consent for enrollment
- Patient has advanced imaging (CT or MRI) that demonstrates an intact rotator cuff
Key exclusion criteria (15 listed)
- Patients under the age of 75
- Need for any structural graft for repair of the shoulder during surgery
- Current infection of the proximal humerus or scapula
- Proximal humerus fracture
- Inadequate or malformed bone that precludes adequate support for prosthesis (B2, B3, C Glenoid morphology)
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 ReplacementParticipants will be randomized to a reverse total shoulder replacement | Procedure or surgery | Reverse total shoulder replacement |
| Anatomic Total Shoulder ReplacementParticipants will be randomized to an anatomic total shoulder replacement | Procedure or surgery | Anatomic total shoulder replacement |
Primary outcome
Postoperative satisfaction
Time frame: 2 years
Investigators will be measuring whether there is an increase in participants satisfaction after surgery as assessed by the American Shoulder and Elbow Score (ASES)
Postoperative Satisfaction
Time frame: 2 years
Investigators will be measuring whether there is an increase in participants satisfaction after surgery as assessed by the Simple Shoulder Test (SST)
Postoperative Pain
Time frame: 2 years
Investigators will be measuring whether there is an increase in participants satisfaction after surgery as assessed by the Visual Analog Scale (VAS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reverse Total Shoulder Replacement and Anatomic Total Shoulder Replacement in people with Total Shoulder Arthoplasty, run by Rothman Institute Orthopaedics 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 15 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 1 Apr 2021. 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?
Postoperative satisfaction (time frame: 2 years). The study lists 3 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 1 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.