Arthritis ShoulderNCT04629391
Anatomic TSA vs RTSA for Glenohumeral Arthritis
A study testing Total shoulder arthroplasty in people with Arthritis Shoulder, run by La Tour Hospital at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Arthritis Shoulder
- What is being tested?
- Total shoulder arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2020to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Primary glenohumeral arthritis,
- Intact rotator cuff,
- No important glenoid bone loss (cf exclusion criteria),
- Patients between 65 and 85 years old
- 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 16Show 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,
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
La Tour Hospital
Meyrin, 1217
Alexandre Lädermann, MD, +41 22 719 75 55, alexandre.laedermann@gmail.com
About this study
Official title: Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis. A Randomized Prospective Study
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. The primary goal of our prospective randomized study is to determine whether 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 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 with a medialized center of rotation to treat cuff tear arthropathy. Favorable early reports led to the expansion of primary indications of RTSA to proximal humeral 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, Steen et al. reported equivalent functional results at >2-year follow-up. The retrospective matched cohort study could, however, not eliminate biases, such that RTSA patients had higher preoperative glenoid retroversion than anatomic TSA patients. The authors therefore hypothesize that, in patients treated for glenohumeral osteoarthritis without excessive glenoid retroversion, RTSA will render better functional outcomes than anatomic TSA, at 2 postoperative years. Many other studies confirmed in 2019 Steen's 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. The primary goal of our prospective randomized study is to determine whether 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.
- Conditions
- Arthritis Shoulder
- Being tested
- Total shoulder arthroplasty
- Keywords
- shoulder, primary osteoarthritis, Range of motion, clinical outcomes, radiographic outcomes, anatomic prosthesis, reverse prosthesis, Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total shoulder arthroplastyDevice
A prosthesis (either anatomic or reverse) will be implanted in shoulders patients that suffer from primary glenohumeral arthritis.
| Study group | Role | What they receive |
|---|---|---|
| Anatomic TSA | Active comparator | The control group will receive through a deltopectoral approach an anatomic total shoulder arthroplasty (TSA) for a primary glenohumeral arthritis Receives: Device: Total shoulder arthroplasty |
| RTSA | Experimental | The experimental group will receive through a deltopectoral approach a reverse total shoulder arthroplasty RTSA for a primary glenohumeral arthritis Receives: Device: Total shoulder arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in American Shoulder and Elbow Surgeons score (ASES)
General clinical score (0-100, with 100 being the best score possible)
Measured: Between baseline and 2 postoperative years
Secondary outcomes (7)
Change in Subjective Shoulder Value (SSV)
General clinical score (0-100, with 100 being the best score possible)
Measured: Between baseline and 2 postoperative years
Change in Range of motion in degrees
(anterior forward flexion, external rotation at the side, internal rotation to nearest spinal level)
Measured: Between baseline and 2 postoperative years
Complication rates
Measured: 2 postoperative years.
Change in pain on visual analogic scale (pVAS)
General clinical score (0-10, with 10 the worst score possible)
Measured: Between baseline and 2 postoperative years
Change in Constant score
General clinical score (0-100, with 100 being the best score possible)
Measured: Between baseline and 2 postoperative years
Change in Short Form -12 (SF-12)
General clinical score (0-100, with 100 being the best score possible)
Measured: Between baseline and 2 postoperative years
Radiographic outcomes
Rates of aseptic loosening, implant migration, implant tilt, scapular notching, glenoid bone loss as defined previously by the investigator
Measured: 2 postoperative years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Sep 2020
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis ShoulderStudies 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
- Outcomes assessor
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- La Tour Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alexandre Lädermann, La Tour Hospital
- Investigators
- Alexandre Lädermann, MD, Principal investigator, La Tour Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629391
- Sponsor's protocol ID
- 2019-02471
- Other IDs
- 2019
- Status last verified
- May 2026
- First submitted
- 25 Aug 2020
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. 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
- NCT04629391
- Acronym / sponsor ID
- 2019-02471
- Conditions
- Arthritis Shoulder
- Keywords
- shoulder, primary osteoarthritis, Range of motion, clinical outcomes, radiographic outcomes, anatomic prosthesis, reverse prosthesis, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- La Tour HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 16 Nov 2020 (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.
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. The primary goal of our prospective randomized study is to determine whether 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.
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 with a medialized center of rotation to treat cuff tear arthropathy. Favorable early reports led to the expansion of primary indications of RTSA to proximal humeral 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, Steen et al. reported equivalent functional results at >2-year follow-up. The retrospective matched cohort study could, however, not eliminate biases, such that RTSA patients had higher preoperative glenoid retroversion than anatomic TSA patients. The authors therefore hypothesize that, in patients treated for glenohumeral osteoarthritis without excessive glenoid retroversion, RTSA will render better functional outcomes than anatomic TSA, at 2 postoperative years. Many other studies confirmed in 2019 Steen's 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. The primary goal of our prospective randomized study is to determine whether 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomic TSA | Active comparator | Device: Total shoulder arthroplastyThe control group will receive through a deltopectoral approach an anatomic total shoulder arthroplasty (TSA) for a primary glenohumeral arthritis |
| RTSA | Experimental | Device: Total shoulder arthroplastyThe experimental group will receive through a deltopectoral approach a reverse total shoulder arthroplasty RTSA for a primary glenohumeral arthritis |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Primary glenohumeral arthritis,
- Intact rotator cuff,
- No important glenoid bone loss (cf exclusion criteria),
- Patients between 65 and 85 years old
- Informed Consent as documented by signature (Appendix Informed Consent Form).
Key exclusion criteria (16 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 |
|---|---|---|
| Total shoulder arthroplastyA prosthesis (either anatomic or reverse) will be implanted in shoulders patients that suffer from primary glenohumeral arthritis. | Device | Anatomic TSA, RTSA |
Primary outcome
Change in American Shoulder and Elbow Surgeons score (ASES)
Time frame: Between baseline and 2 postoperative years
General clinical score (0-100, with 100 being the best score possible)
7 secondary outcomes
Change in Subjective Shoulder Value (SSV)
Time frame: Between baseline and 2 postoperative years
Change in Range of motion in degrees
Time frame: Between baseline and 2 postoperative years
Complication rates
Time frame: 2 postoperative years.
Change in pain on visual analogic scale (pVAS)
Time frame: Between baseline and 2 postoperative years
Change in Constant score
Time frame: Between baseline and 2 postoperative years
Change in Short Form -12 (SF-12)
Time frame: Between baseline and 2 postoperative years
Radiographic outcomes
Time frame: 2 postoperative years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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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.
Alexandre Lädermann, MD principal investigator
La Tour Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total shoulder arthroplasty in people with Arthritis Shoulder, run by La Tour Hospital at 1 site in Switzerland.
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 16 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Lädermann, MD (+41 22 719 75 55, alexandre.laedermann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in American Shoulder and Elbow Surgeons score (ASES) (time frame: Between baseline and 2 postoperative years). 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 22 May 2026.