Clinical trial NCT04432012: A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Total Knee Replacement
Keywords: Knee
surgery
replacement
arthroplasty
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 159
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Mean daily pain at rest during the first 3 days on a 0-10 numeric rating scale
timeFrame: 3 days after surgery
Secondary outcomes:
measure: Post-operative knee pain during the first 6 weeks after surgery on a 0-10 numeric rating scale
timeFrame: 6 weeks after surgery
measure: Post-operative knee pain during the first 10 years after surgery
timeFrame: 10 years
measure: Post-operative function during the first 6 weeks after surgery
timeFrame: 6 weeks
measure: Post-operative knee function during the first 10 years after surgery
timeFrame: 10 years
measure: Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 10 years
measure: Knee conditions on Knee society score (KSS)
timeFrame: 10 years
measure: Quality of pain on PainDETECT questionnaire
timeFrame: 10 years
measure: Patient satisfaction: numeric rating scale (NRS)
timeFrame: 10 years
measure: Post-operative nausea incidence
timeFrame: During Hospitalization, approximately 3 days
measure: Post-operative nausea intensity
timeFrame: During Hospitalization, approximately 3 days
measure: Post-operative opioids and analgesic drugs consumption
timeFrame: During Hospitalization, approximately 3 days
measure: Post-operative C-Reactive Protein (CRP)
timeFrame: every days 3 days from surgery
measure: Post-operative erythrocyte sedimentation rate (ESR)
timeFrame: every days 3 days from surgery
measure: Time from surgery to first mobilization
timeFrame: During Hospitalization, approximately 1 days
measure: Time needed for climbing stairs the first time
timeFrame: approximately 1 week
measure: Length of hospital stay
timeFrame: approximately 1 week
Other outcomes:
measure: Number of patients with treatment-related adverse events
timeFrame: 10 years
Locations:
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano Civico e Italiano
Study officials:
affiliation: EOC
name: Christian Candrian, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: