A Phase 4 interventional study of dexamethasone in Arthroplasty, Replacement, Shoulder, sponsored by Christian Candrian. Recruiting at 1 site in Switzerland. Open to participants aged 58 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Christian Candrian · Phase 4, Interventional, and Treatment
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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
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.
Christian Candrian is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
• 9 mg of i.v. dexamethasone
Drug: dexamethasone
• no steroid supplementation
perioperatively 9 mg i.v subministration
Also known as: Steroids
mean post-operative daily pain at rest
0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful
Time frame: first 3 days after surgery
Post-operative shoulder pain
0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful
Time frame: first 3 months after surgery
Post-operative shoulder pain
0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful
Time frame: 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
Time frame: 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
Time frame: 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
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)
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
Time frame: 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%.
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
"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
Time frame: 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.
Time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
Patient satisfaction
0-10 numeric rating scale (NRS)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: preoperatively and first 3 days post-operative days during hospitalisation
Time from surgery to first mobilization
Time from surgery to first mobilization
Time frame: 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
Time frame: 1 week post-operative during hospitalisation
Rate of serious adverse events related to steroid supplementation
Rate of serious adverse events related to steroid supplementation
Time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
Rate of prosthetic joint infections
Rate of prosthetic joint infections
Time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
Rate of wound infections
Rate of wound infections
Time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
Rate of wound healing problems
Rate of wound healing problems
Time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
Plan to share: No — not foreseen
No publications or documents are linked to this record.
Started Sep 2020 (actual). Primary completion is estimated for Jul 2032, 142 months after the start.
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Studies of the drug tested here: Dexamethasone
Christian Candrian