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
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.
Exclusion Criteria:
• 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
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Christian Candrian