Arthroplasty, Replacement, ShoulderPhase 4NCT04507412
Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty
A Phase 4 study testing dexamethasone in people with Arthroplasty, Replacement, Shoulder, run by Christian Candrian at 1 site in Switzerland.
Trial summary
The aim of the study is to evaluate if intravenous steroid supplementation can provide advantages over routine analgesia protocols in terms of post-operative symptoms (pain and nausea), length of hospital stay, shoulder range of motion, function and patient satisfaction Read more about this study
- Who is it for?
- Ages 58 to 85 years
- Conditions the study is for
- Arthroplasty, Replacement, Shoulder
- What is being tested?
- dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Sep 2020to 31 Aug 2032
- Phase
- Phase 4
- 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 58 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral primary total anatomical or reverse shoulder arthroplasty (Total Shoulder Arthroplasty)
- Patients with a BMI >18.5 and <35
- Patients able to provide informed consent and follow all the study procedures as indicated by the protocol
- Informed Consent as documented by signature
Who cannot join
- Contraindications to steroids
- Revision and post-traumatic TSA
- Active steroid or immunosuppressive therapy in the last 30 days before the operation
- Pregnant or breast-feeding women
- Presence of other clinically significant concomitant disease states (ASA IV)
- Uncontrolled diabetes mellitus
Show all 13Show fewer
- Contraindications to Non-steroidal anti-inflammatory drugs
- Chronic systemic diseases as immunodeficiency, autoimmune disease (Systemic Lupus Erythematosus), gout, rheumatic arthritis
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Previous enrolment into the current study
- 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
Christian Candrian
Lugano, 6900
Christian Candrian, Prof.Dr.med, +41 (0) 91 811 61 23, christian.candrian@eoc.ch
Gianluigi Capone, Dr., gianluigi.capone@eoc.ch
About this study
Official title: Effect of Perioperative Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty for Osteoarthritis, in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications
The aim of the study is to evaluate if intravenous steroid supplementation can provide advantages over routine analgesia protocols in terms of post-operative symptoms (pain and nausea), length of hospital stay, shoulder range of motion, function and patient satisfaction
Read the detailed description
The purpose of this study is to detect the efficacy of intravenous perioperative steroid supplementation for total shoulder arthroplasty (TSA) surgeries in terms of short-term and long-term clinical outcomes and to demonstrate its advantages over the routine anaesthesia protocol. The comparison will be evaluated in terms of post- operative pain and function, opioids and analgesic drugs consumption, patient satisfaction, patient reported outcome measures (validated clinical scores), clinician-assessed clinical scores, systemic inflammatory response, length of hospital stay and long-term outcomes. Moreover, to confirm the safety of steroid supplementation all treatment related adverse events- and reactions are going to be recorded and reported, as well as post-operative glycaemia will be monitored.
The primary objective of the study is to show the efficacy on post-operative pain of intravenous perioperative dexamethasone supplementation for TSA.
The secondary objectives of the study are to show superiority by comparison of the intravenous peri- operative dexamethasone supplementation group to the routine analgesia protocol (no steroid supplementation group), in terms of post-operative pain and function, patient satisfaction, shoulder active- and passive range of motion, quantification with validated clinician- and patient reported outcome measures as the Constant, ASES and SSV Scores for function and EQ-5D-3L Score for health-related quality of life, opioids and analgesic drugs consumption, systemic inflammatory response, time until first mobilization and until the patient first slept through at night, the length of hospital stay and presence or absence of a frozen shoulder at the postoperative follow-up, as well as adverse events and reactions, in order to document the advantage over the absence of steroid supplementation in the short-, mid- term- and long-term follow up.
- Conditions
- Arthroplasty, Replacement, Shoulder
- Being tested
- dexamethasone
- Keywords
- Total Shoulder Arthroplasty, steroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
Also called Steroids
perioperatively 9 mg i.v subministration
| Study group | Role | What they receive |
|---|---|---|
| arm A | Experimental | • 9 mg of i.v. dexamethasone Receives: Drug: dexamethasone |
| arm B | No intervention | • no steroid supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean post-operative daily pain at rest
0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful
Measured: first 3 days after surgery
Secondary outcomes (15)
Post-operative shoulder pain
0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful
Measured: first 3 months after surgery
Post-operative shoulder pain
0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful
Measured: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
Post-operative global shoulder function score
0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most functional
Measured: daily during the first 3 months
Post-operative global shoulder function score
0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most functional
Measured: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
The clinician assessed Constant score
The Constant Score questionnaire consists of 8 questions (giving a score of 0 -100, with 100 being the best score) evaluating pain, activity level and range of motion
Measured: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES Score)
The ASES Score is a patient reported outcome measure (PROM), a validated score evaluating pain and function for daily living and leisure activity. A maximum of 100 points means maximum (normal) functionality and no pain. MCID is 13.6 ± 2.3 points after total shoulder prosthesis
Measured: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
The Subjective Shoulder Value (SSV)
The SSV is a percent of the subjective value of the shoulder given from the patient from 0-100%.
Measured: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
European Quality of Life-5 Dimensions-3 Level
"Health-Related Quality-of-Life Score" and is preferred evaluating cost utility analysis and changes in general health after surgical operations. It contains 5 questions and the maximum (best) score is 1. MCID is 0.07 units
Measured: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
PainDETECT
PainDETECT consists of seven questions that address the quality of pain symptoms; it is completed by the patient and no physical examination is required. A score ≤12 indicates that pain is unlikely to have a neuropathic component (< 15%), while a score of ≥19 suggests that pain is likely to have a neuropathic component (> 90%). An intermediate score (≥13, ≤18) indicates a possible neuropathic component.
Measured: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
Patient satisfaction
0-10 numeric rating scale (NRS)
Measured: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
Post-operative nausea
incidence and intensity (on a 0-10 NRS) will be evaluated. The 0-10 NRS is a valid and reliable instrument used for the self- assessment of symptoms: it consists in a single 11-point numeric scale, with 0 indicating no nausea and 10 reflecting the worst possible nausea
Measured: first 3 days post-operative days during hospitalisation
Post-operative opioids and analgesic drugs consumption
Medication Quantification Scale (MQS) score. It is calculated for each medication by taking a consensus-based detriment weight for a given pharmacologic class and multiplying it by a score for dosage. The calculated values for each medication are then summed for a total MQS score. The score can provide a useful point measure of medication usage for any pain medication regime
Measured: first 3 days post-operative days during hospitalisation
Postoperative inflammatory response
This outcome will be evaluated in terms of hematic C-Reactive Protein (CRP) and erythrocyte sedimentation rate (ESR) (the medical chart will be evaluated)
Measured: preoperatively and first 3 days post-operative days during hospitalisation
Time from surgery to first mobilization
Time from surgery to first mobilization
Measured: During Hospitalization, approximately 1 days
Rate of frozen shoulders
This is considered a complication occurring up to 11% and is induced by postoperative inflammatory processes that can lead to adhesive capsulitis
Measured: 1 week post-operative during hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start9 Sep 2020
- Primary completion31 Jul 2032 (estimated)
- Study completion31 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a 2-arm randomized controlled trial comparing i.v. dexamethasone supplementation (arm-A) and no steroid supplementation (arm-B) for total shoulder arthroplasty
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Candrian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Candrian, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Christian Candrian, Prof.Dr.med, Principal investigator, EOC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507412
- Sponsor's protocol ID
- ORL-ORT- 020
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2020
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not foreseen
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty for Osteoarthritis, in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications
- ClinicalTrials.gov ID
- NCT04507412
- Acronym / sponsor ID
- ORL-ORT- 020
- Conditions
- Arthroplasty, Replacement, Shoulder
- Keywords
- Total Shoulder Arthroplasty, steroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Christian CandrianUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 31 Jul 2032 (estimated)
- Study completion
- 31 Aug 2032 (estimated)
- First posted
- 11 Aug 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.
The aim of the study is to evaluate if intravenous steroid supplementation can provide advantages over routine analgesia protocols in terms of post-operative symptoms (pain and nausea), length of hospital stay, shoulder range of motion, function and patient satisfaction
Detailed description
The purpose of this study is to detect the efficacy of intravenous perioperative steroid supplementation for total shoulder arthroplasty (TSA) surgeries in terms of short-term and long-term clinical outcomes and to demonstrate its advantages over the routine anaesthesia protocol. The comparison will be evaluated in terms of post- operative pain and function, opioids and analgesic drugs consumption, patient satisfaction, patient reported outcome measures (validated clinical scores), clinician-assessed clinical scores, systemic inflammatory response, length of hospital stay and long-term outcomes. Moreover, to confirm the safety of steroid supplementation all treatment related adverse events- and reactions are going to be recorded and reported, as well as post-operative glycaemia will be monitored.
The primary objective of the study is to show the efficacy on post-operative pain of intravenous perioperative dexamethasone supplementation for TSA.
The secondary objectives of the study are to show superiority by comparison of the intravenous peri- operative dexamethasone supplementation group to the routine analgesia protocol (no steroid supplementation group), in terms of post-operative pain and function, patient satisfaction, shoulder active- and passive range of motion, quantification with validated clinician- and patient reported outcome measures as the Constant, ASES and SSV Scores for function and EQ-5D-3L Score for health-related quality of life, opioids and analgesic drugs consumption, systemic inflammatory response, time until first mobilization and until the patient first slept through at night, the length of hospital stay and presence or absence of a frozen shoulder at the postoperative follow-up, as well as adverse events and reactions, in order to document the advantage over the absence of steroid supplementation in the short-, mid- term- and long-term follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a 2-arm randomized controlled trial comparing i.v. dexamethasone supplementation (arm-A) and no steroid supplementation (arm-B) for total shoulder arthroplasty
| Arm | Type | Receives |
|---|---|---|
| arm A | Experimental | Drug: dexamethasone• 9 mg of i.v. dexamethasone |
| arm B | No intervention | –• no steroid supplementation |
Who may qualify
- Ages
- 58 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing unilateral primary total anatomical or reverse shoulder arthroplasty (Total Shoulder Arthroplasty)
- Patients with a BMI >18.5 and <35
- Patients able to provide informed consent and follow all the study procedures as indicated by the protocol
- Informed Consent as documented by signature
Key exclusion criteria (13 listed)
- Contraindications to steroids
- Revision and post-traumatic TSA
- Active steroid or immunosuppressive therapy in the last 30 days before the operation
- Pregnant or breast-feeding women
- Presence of other clinically significant concomitant disease states (ASA IV)
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 |
|---|---|---|
| dexamethasoneAlso: Steroidsperioperatively 9 mg i.v subministration | Drug | arm A |
Primary outcome
mean post-operative daily pain at rest
Time frame: first 3 days after surgery
0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful
15 secondary outcomes
Post-operative shoulder pain
Time frame: first 3 months after surgery
Post-operative shoulder pain
Time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
Post-operative global shoulder function score
Time frame: daily during the first 3 months
Post-operative global shoulder function score
Time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
The clinician assessed Constant score
Time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES Score)
Time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
The Subjective Shoulder Value (SSV)
Time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
European Quality of Life-5 Dimensions-3 Level
Time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
PainDETECT
Time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
Patient satisfaction
Time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
Post-operative nausea
Time frame: first 3 days post-operative days during hospitalisation
Post-operative opioids and analgesic drugs consumption
Time frame: first 3 days post-operative days during hospitalisation
Postoperative inflammatory response
Time frame: preoperatively and first 3 days post-operative days during hospitalisation
Time from surgery to first mobilization
Time frame: During Hospitalization, approximately 1 days
Rate of frozen shoulders
Time frame: 1 week post-operative during hospitalisation
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 9 Sep 2026.
- Individual participant dataSharing planned: No. not foreseen
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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.
Christian Candrian, Prof.Dr.med principal investigator
EOC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexamethasone in people with Arthroplasty, Replacement, Shoulder, run by Christian Candrian 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 4 inclusion and 13 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 9 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Christian Candrian, Prof.Dr.med (+41 (0) 91 811 61 23, christian.candrian@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean post-operative daily pain at rest (time frame: first 3 days after surgery). 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 9 Sep 2026.