Glenohumeral OsteoarthritisNCT06513559
Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis
A study testing Anatomic total shoulder replacement and Reverse total shoulder replacement in people with Glenohumeral Osteoarthritis, run by University of Utah at 1 site in United States.
Trial summary
The primary goal of the investigators prospective randomized study is to determine whether reverse total shoulder arthroplasty (RTSA) have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Glenohumeral Osteoarthritis
- What is being tested?
- Anatomic total shoulder replacement and Reverse total shoulder replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2023to 30 Oct 2024
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary glenohumeral arthritis,
- Intact rotator cuff,
- No important glenoid bone loss (cf exclusion criteria),
- Patients between 60 and 85 years old (based on indications for RTSA)
- Informed Consent as documented by signature (Appendix Informed Consent Form).
Who cannot join
- B2 glenoid with > 80% posterior humeral head subluxation or greater 25 degrees neoglenoid retroversion,
- B3 and C type glenoids,
- Full thickness rotator cuff tear,
- Acute or malunited proximal humeral fracture,
- Chronic locked dislocation
- Rheumatoid arthritis,
Show all 15Show fewer
- Revision surgery or surgical antecedents,
- Tumors,
- Axillary nerve damage,
- Non-functioning deltoid muscle,
- Glenoid vault deficiency precluding baseplate fixation,
- Infection and neuropathic joints,
- Known or suspected non-compliance, drug or alcohol abuse,
- Patients incapable of judgement or under tutelage,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for CT scan etc. of the participant,
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopedics
Salt Lake City, Utah, 84108
About this study
Official title: Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis: a Randomized Prospective Study
The primary goal of the investigators prospective randomized study is to determine whether reverse total shoulder arthroplasty (RTSA) have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion.
The secondary goals are 1) to evaluate whether RTSA eventually grants superior postoperative clinical and radiographic outcomes than anatomic TSA (superiority), 2) to determine whether RTSA is associated with fewer postoperative complications than anatomic TSA.
Read more
The devices being used in the research are an Arthrex Universe system (Arthrex Univers Reverse vs Arthrex Apex humeral stem or Eclipse stem with a polyethylene glenoid). They are FDA approved, commonly used, and used as indicated. The anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component. The reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side.
In all cases, a deltopectoral incision will be used as the procedure type.
Read the detailed description
Total anatomic shoulder arthroplasty (TSA) is an effective treatment of severe glenohumeral osteoarthritis, with significant improvement in shoulder pain and function. Concerns about glenoid loosening, associated with difficult revision procedures and disappointing outcomes, have however been raised.
Reverse total shoulder arthroplasty (RTSA) was designed to treat cuff tear arthropathy. Favorable early reports led to the expansion of using RTSA to treat other shoulder fractures as well as osteoarthritis with poor glenoid bone stock. Recent reports revealed excellent clinical results of RTSA for primary glenohumeral arthropathy with intact rotator cuff and a low rate of complications.
Retrospective studies comparing functional results - of anatomic TSA for treating glenohumeral osteoarthritis with RTSA for rotator cuff arthropathy - found equivalent or greater improvements in American Shoulder and Elbow Surgeons score (ASES) at >2-year follow-up. In a study comparing anatomic TSA to RTSA for the treatment of glenohumeral osteoarthritis with intact rotator cuffs, investigators have reported equivalent functional results at >2-year follow-up. However, this study could not eliminate biases, such that RTSA patients had higher preoperative glenoid retroversion than anatomic TSA patients.The investigators therefore hypothesize that, in patients treated for glenohumeral osteoarthritis, RTSA will render better functional outcomes than anatomic TSA, at 2 postoperative years. Many other studies have confirmed this hypothesis. Moreover, several studies revealed good long-term survivorship after RTSA.
There are no published prospective studies that compared 2-year functional outcomes of RTSA and anatomic TSA for the treatment of primary glenohumeral osteoarthritis with intact rotator cuffs and no excessive glenoid retroversion.
- Conditions
- Glenohumeral Osteoarthritis
- Being tested
- Anatomic total shoulder replacement, Reverse total shoulder replacement
- Keywords
- glenohumeral osteoarthritis, reverse total shoulder arthroplasty, anatomic replacement, reverse replacement, range of motion, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomic total shoulder replacementDevice
Also called Arthrex Eclipse stem with a polyethylene glenoid., Stryker perform stem with cortiloc glenoid, Enovis CS Edge stem with altivate anatomic glenoid, Exactech Equinoxe stem with cage anatomic glenoid
Humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component.
Reverse total shoulder replacementDevice
Also called Arthrex Universe Reverse., Stryker perform reverse, Enovis Altivate reverse, Exactech Equinoxe reverse
Polyethylene socket on the humeral side and the glenosphere going on the glenoid side.
| Study group | Role | What they receive |
|---|---|---|
| Anatomic total shoulder replacement | Experimental | Anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component. Receives: Device: Anatomic total shoulder replacement |
| Reverse total shoulder replacement | Experimental | Reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side. Receives: Device: Reverse total shoulder replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons score
Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
Measured: date of surgery
American Shoulder and Elbow Surgeons score
Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
Measured: 6 months after date of surgery
American Shoulder and Elbow Surgeons score
Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
Measured: 12 months after date of surgery
American Shoulder and Elbow Surgeons score
Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
Measured: 24 months after date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start2 Aug 2023
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Why it stopped: There was difficulty getting the study up and running with the site, staffing issues, completing a DTA and concern over sufficient patient population. The study was stopped without any enrollment. No results were obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glenohumeral OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Joyce, University of Utah
- Investigators
- Christopher Joyce, M.D., Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513559
- Sponsor's protocol ID
- 159808
- Status last verified
- Feb 2025
- First submitted
- 8 Jul 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis: a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT06513559
- Acronym / sponsor ID
- 159808
- Conditions
- Glenohumeral Osteoarthritis
- Keywords
- glenohumeral osteoarthritis, reverse total shoulder arthroplasty, anatomic replacement, reverse replacement, range of motion, pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There was difficulty getting the study up and running with the site, staffing issues, completing a DTA and concern over sufficient patient population. The study was stopped without any enrollment. No results were obtained.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 22 Jul 2024 (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 primary goal of the investigators prospective randomized study is to determine whether reverse total shoulder arthroplasty (RTSA) have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion.
The secondary goals are 1) to evaluate whether RTSA eventually grants superior postoperative clinical and radiographic outcomes than anatomic TSA (superiority), 2) to determine whether RTSA is associated with fewer postoperative complications than anatomic TSA.
The devices being used in the research are an Arthrex Universe system (Arthrex Univers Reverse vs Arthrex Apex humeral stem or Eclipse stem with a polyethylene glenoid). They are FDA approved, commonly used, and used as indicated. The anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component. The reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side.
In all cases, a deltopectoral incision will be used as the procedure type.
Detailed description
Total anatomic shoulder arthroplasty (TSA) is an effective treatment of severe glenohumeral osteoarthritis, with significant improvement in shoulder pain and function. Concerns about glenoid loosening, associated with difficult revision procedures and disappointing outcomes, have however been raised.
Reverse total shoulder arthroplasty (RTSA) was designed to treat cuff tear arthropathy. Favorable early reports led to the expansion of using RTSA to treat other shoulder fractures as well as osteoarthritis with poor glenoid bone stock. Recent reports revealed excellent clinical results of RTSA for primary glenohumeral arthropathy with intact rotator cuff and a low rate of complications.
Retrospective studies comparing functional results - of anatomic TSA for treating glenohumeral osteoarthritis with RTSA for rotator cuff arthropathy - found equivalent or greater improvements in American Shoulder and Elbow Surgeons score (ASES) at >2-year follow-up. In a study comparing anatomic TSA to RTSA for the treatment of glenohumeral osteoarthritis with intact rotator cuffs, investigators have reported equivalent functional results at >2-year follow-up. However, this study could not eliminate biases, such that RTSA patients had higher preoperative glenoid retroversion than anatomic TSA patients.The investigators therefore hypothesize that, in patients treated for glenohumeral osteoarthritis, RTSA will render better functional outcomes than anatomic TSA, at 2 postoperative years. Many other studies have confirmed this hypothesis. Moreover, several studies revealed good long-term survivorship after RTSA.
There are no published prospective studies that compared 2-year functional outcomes of RTSA and anatomic TSA for the treatment of primary glenohumeral osteoarthritis with intact rotator cuffs and no excessive glenoid retroversion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomic total shoulder replacement | Experimental | Device: Anatomic total shoulder replacementAnatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component. |
| Reverse total shoulder replacement | Experimental | Device: Reverse total shoulder replacementReverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary glenohumeral arthritis,
- Intact rotator cuff,
- No important glenoid bone loss (cf exclusion criteria),
- Patients between 60 and 85 years old (based on indications for RTSA)
- Informed Consent as documented by signature (Appendix Informed Consent Form).
Key exclusion criteria (15 listed)
- B2 glenoid with > 80% posterior humeral head subluxation or greater 25 degrees neoglenoid retroversion,
- B3 and C type glenoids,
- Full thickness rotator cuff tear,
- Acute or malunited proximal humeral fracture,
- Chronic locked dislocation
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 |
|---|---|---|
| Anatomic total shoulder replacementAlso: Arthrex Eclipse stem with a polyethylene glenoid., Stryker perform stem with cortiloc glenoid, Enovis CS Edge stem with altivate anatomic glenoid, Exactech Equinoxe stem with cage anatomic glenoidHumeral head with a metal ball and the glenoid socket with a polyethylene glenoid component. | Device | Anatomic total shoulder replacement |
| Reverse total shoulder replacementAlso: Arthrex Universe Reverse., Stryker perform reverse, Enovis Altivate reverse, Exactech Equinoxe reversePolyethylene socket on the humeral side and the glenosphere going on the glenoid side. | Device | Reverse total shoulder replacement |
Primary outcome
American Shoulder and Elbow Surgeons score
Time frame: date of surgery
Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
American Shoulder and Elbow Surgeons score
Time frame: 6 months after date of surgery
Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
American Shoulder and Elbow Surgeons score
Time frame: 12 months after date of surgery
Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
American Shoulder and Elbow Surgeons score
Time frame: 24 months after date of surgery
Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
Related trials for Glenohumeral Osteoarthritis
RecruitingPhase 4
PRP for Glenohumeral Osteoarthritis
Shoulder Osteoarthritis
Enrolling by invitationObservational study
Subscapularis-Sparing Total Shoulder Arthroplasty
Total Shoulder Arthroplasty
Active, not recruitingObservational study
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
Rotator Cuff Tears, Rheumatoid Arthritis Shoulder
Enrolling by invitation
Glenohumeral OsteoArthritis Therapy Trial
Glenohumeral Arthritis, Shoulder Arthritis Osteoarthritis
RecruitingObservational study
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
Glenohumeral Osteoarthritis, Proximal Humerus Fracture
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.
Christopher Joyce, M.D. principal investigator
University of Utah Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomic total shoulder replacement and Reverse total shoulder replacement in people with Glenohumeral Osteoarthritis, run by University of Utah 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 5 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: withdrawn, as of the sponsor's last update on 28 Feb 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
American Shoulder and Elbow Surgeons score (time frame: date of surgery). The study lists 4 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 28 Feb 2025.