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

Christian Candrian

Status and phase: Enrolling; Phase 4

Conditions: Total Knee Replacement

Treatments: Drug: Dexamethasone Sodium Phosphate 4 mg/ml intra-articular; Drug: Dexamethasone Sodium Phosphate 4 mg/ml intravenous

Study type: Interventional

Funder types: Other

Identifiers

NCT04432012

ORL-ORT-013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 159 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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159 participants in 3 patient groups

arm-A Intra-venous dexamethasone

Experimental group

Description:

9 mg of Intra-venous dexamethasone

Treatment:

Drug: Dexamethasone Sodium Phosphate 4 mg/ml intravenous

arm-B intra-articular dexamethasone

Experimental group

Description:

9 mg of intra-articular dexamethasone

Treatment:

Drug: Dexamethasone Sodium Phosphate 4 mg/ml intra-articular

arm-C routine

No Intervention group

Description:

No steroid supplementation or other drugs will be added to the routinely performed anaesthesia protocol in the control group