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

NCT04432012 | Recruiting Phase 4

• 1 other identifier: ORL-ORT-013
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Replacement

Keywords

Knee; surgery; replacement; arthroplasty

Outcome Measures

Primary Outcomes (1)

• Mean daily pain at rest during the first 3 days on a 0-10 numeric rating scale

  Mean daily pain at rest during the first 3 days reported on a 0-10 numeric rating scale (NRS) by the patients. The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no pain and 10 reflecting the worst possible pain.

  3 days after surgery

Secondary Outcomes (16)

• Post-operative knee pain during the first 6 weeks after surgery on a 0-10 numeric rating scale

  6 weeks after surgery

• Post-operative knee pain during the first 10 years after surgery

  10 years

• Post-operative function during the first 6 weeks after surgery

  6 weeks

• Post-operative knee function during the first 10 years after surgery

  10 years

• Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  10 years

Other Outcomes (1)

• Number of patients with treatment-related adverse events

  10 years

Study Arms (3)

arm-A Intra-venous dexamethasone

EXPERIMENTAL

9 mg of Intra-venous dexamethasone

Drug: Dexamethasone Sodium Phosphate 4 mg/ml intravenous

arm-B intra-articular dexamethasone

EXPERIMENTAL

9 mg of intra-articular dexamethasone

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

arm-C routine

NO INTERVENTION

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

Interventions

Dexamethasone Sodium Phosphate 4 mg/ml intravenous DRUG

Perioperative intravenous injection of 3 ml of solution (9mg of dexamethasone)

Also known as: Mephameson

arm-A Intra-venous dexamethasone

Dexamethasone Sodium Phosphate 4 mg/ml intra-articular DRUG

Perioperative intra-articular injection of 3 ml of solution (9mg of dexamethasone)

Also known as: Mephameson

arm-B intra-articular dexamethasone

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christian Candrian: lead

Study Sites (1)

Ospedale Regionale di Lugano Civico e Italiano

Lugano, 6900, Switzerland

RECRUITING

MeSH Terms

Interventions

dexamethasone 21-phosphate

Study Officials

• Christian Candrian, MD, Prof.

  EOC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Candrian, MD, Prof

CONTACT

+41 (0) 91 811 61 23; christian.candrian@eoc.ch

Marco Delcogliano, MD

CONTACT

+41 (0)91 811 66 56; marco.delcogliano@eoc.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The present study will be double blinded: both participants and assessor will be blinded to the assigned treatment. Only the surgeons and the anaesthetists taking part to surgery will be aware of the group to which the patient was assigned but they will not take part to the follow-up visits.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 16, 2020
• Study Start: July 1, 2020
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2033
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)