A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation

STATUS

Recruiting
End date

Sep 1, 2032
participants needed

159
sponsor

Christian Candrian

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Updated on 19 February 2024

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anesthesia

osteoarthritis

total knee replacement

dexamethasone

dexamethasone sodium phosphate

Summary

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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.

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.

Details

Condition	Repair of knee joint, knee surgery, knee surgery
Age	50years - 85years
Treatment	Dexamethasone Sodium Phosphate 4 mg/ml intravenous, Dexamethasone Sodium Phosphate 4 mg/ml intra-articular
Clinical Study Identifier	NCT04432012
Sponsor	Christian Candrian
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation