A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexamethasone Sodium Phosphate 4 mg/ml intravenous, Dexamethasone Sodium Phosphate 4 mg/ml intra-articular.
- Who it may be relevant to
- Registry conditions: Total Knee Replacement. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Perioperative Intravenous vs Periarticular Dexamethasone vs no Steroid Supplementation in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications in Patients Undergoing Primary Total Knee Arthroplasty for Knee Osteoarthritis - A Randomized Controlled Trial Clinical Study Protocol
Overview
We are going to evaluate the difference between perioperative intravenous steroid supplementation, perioperative periarticular steroid supplementation, and standard anaesthesia protocols. We'll evaluate the outcome of patients with knee osteoarthritis who are undergoing Total Knee Arthroplasty to understand which of the three treatments give more benefits to the patient.
Detailed description
A total of 159 patients will be needed (53 patients per arm, 3 arms in total). Dexamethasone (brand name: Mephameson) is the steroid drug that we perioperative administer in two different ways: intra-venous (IV) dexamethasone (9mg) in arm-A, intra-articular (IA) dexamethasone (9mg) in arm-B. No steroid supplementation will be provided in the control group (arm-C).
The primary objective of the study is to compare the effect on post-operative pain of I.V. and I.A. perioperative dexamethasone supplementation for total knee arthroplasty (TKA).
The secondary objectives of the studies will be the comparison between I.V. and I.A. peri-operative dexamethasone supplementation in terms of post-operative pain and function, opioids and analgesic drugs consumption, knee range of motion, systemic inflammatory response, time to mobilisation, length of stay, and patient satisfaction.
Moreover, both I.V. and I.A. steroid supplementation protocols will be compared to routine analgesia protocol (no steroid supplementation group) in order to document their advantages over the absence of steroid supplementation.
The safety of I.V. and I.A. peri-operative dexamethasone will be evaluated and compared recording all the steroid supplementation related complications. In particular, the risk of hyperglycaemia-related complications and post-operative infections will be documented. The safety of both I.V. and I.A. steroid supplementation protocols will be verified comparing them to the no-treatment group in terms of incidence of complications.
Overall study duration will be 12 years: 2 years to enroll all the patients and 10 years to complete the last follow-up. Primary data analysis is planned after the completion of the 1-year follow-up visits.
Interventions
- Drug Dexamethasone Sodium Phosphate 4 mg/ml intravenous
Perioperative intravenous injection of 3 ml of solution (9mg of dexamethasone) - Drug Dexamethasone Sodium Phosphate 4 mg/ml intra-articular
Perioperative intra-articular injection of 3 ml of solution (9mg of dexamethasone)
Primary outcome measures
- Mean daily pain at rest during the first 3 days on a 0-10 numeric rating scale [Time frame: 3 days after surgery]
Secondary outcome measures (12)
- Post-operative knee pain during the first 6 weeks after surgery on a 0-10 numeric rating scale [Time frame: 6 weeks after surgery]
- Post-operative knee pain during the first 10 years after surgery [Time frame: 10 years]
- Post-operative function during the first 6 weeks after surgery [Time frame: 6 weeks]
- Post-operative knee function during the first 10 years after surgery [Time frame: 10 years]
- Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index (WOMAC) [Time frame: 10 years]
- Knee conditions on Knee society score (KSS) [Time frame: 10 years]
- Quality of pain on PainDETECT questionnaire [Time frame: 10 years]
- Patient satisfaction: numeric rating scale (NRS) [Time frame: 10 years]
- Post-operative nausea incidence [Time frame: During Hospitalization, approximately 3 days]
- Post-operative nausea intensity [Time frame: During Hospitalization, approximately 3 days]
- Post-operative opioids and analgesic drugs consumption [Time frame: During Hospitalization, approximately 3 days]
- Post-operative C-Reactive Protein (CRP) [Time frame: every days 3 days from surgery]
Eligibility criteria
Inclusion criteria
- Patients undergoing unilateral primary TKA at the Ospedale Regionale di Lugano.
- 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 (Appendix Informed Consent Form).
Exclusion criteria
- Contraindications to steroids.
- Revision TKA.
- Active steroid therapy.
- Women who are pregnant or breast feeding.
- Presence of other clinically significant concomitant disease states (ASA IV).
- Uncontrolled diabetes mellitus
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Ospedale Regionale di Lugano Civico e Italiano — Lugano
Identifiers
NCT: NCT04432012 · ORL-ORT-013