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NCT Number: NCT04432012

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

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.

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Key information

Conditions

Total Knee Replacement

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ospedale Regionale di Lugano Civico e Italiano

Lugano, 6900, Switzerland

Location status: Recruiting

Location contact

Christian Candrian, MD, Prof

CONTACT

[email protected]

+41 (0)91 811 7029

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone Sodium Phosphate 4 mg/ml intravenous

Drug

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

Other names: Mephameson

Dexamethasone Sodium Phosphate 4 mg/ml intra-articular

Drug

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

Other names: Mephameson

Primary outcomes

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

    Time frame: 3 days after surgery

    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.

Secondary outcomes

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

    Time frame: 6 weeks after surgery

    Pain reported on 0-10 numeric rating scale (NRS) during the first 6 weeks and documented with a mobile application (developed at our Institution) that will ask the patients to report pain twice a day (once in the morning, once in the evening). Comparison will be performed in terms of mean daily pain during the first 6 weeks and mean daily pain during every single week.

    The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no pain and 10 reflecting the worst possible pain.

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

    Time frame: 10 years

    reported on 0-10 NRS at 3, 6, 12, 24, 60 and 120 months using a questionnaire. 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. Post-operative function during the first 6 weeks after surgery

    Time frame: 6 weeks

    reported on 0-10 NRS 8see above) during the first 6 weeks, documented with a mobile application developed by our institution that will ask the patients to report pain twice a day (once in the morning, once in the evening). Comparison will be performed in terms of mean daily pain during the first 6 weeks and mean daily pain during every single week. Furthermore, pain trajectories will be created.

    The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating the worst possible function and 10 reflecting the best possible function.

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

    Time frame: 10 years

    reported on 0-10 NRS at 3, 6, 12, 24, 60 and 120 months using a questionnaire. The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating the worst possible function and 10 reflecting the best possible function.

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

    Time frame: 10 years

    Questionnaire at 2 and 6 weeks, and at 3, 6, 12, 24, 60 and 120 months. The WOMAC questionnaire is composed of 3 sub-scores that evaluate pain (5 questions, 0-20 points), stiffness (2 questions, 0-8 points), and function (17 questions, 0-68 points) and is a validated patient-reported outcome measure (PROM) to evaluate knee osteoarthritis.

    Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  6. Knee conditions on Knee society score (KSS)

    Time frame: 10 years

    Questionnaire at 2 and 6 weeks, and at 3, 6, 12, 24, 60 and 120 months. The original KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.

  7. Quality of pain on PainDETECT questionnaire

    Time frame: 10 years

    Questionnaire at 2 and 6 weeks, and at 3, 6, 12, 24, 60 and 120 months. PainDETECT consists of seven questions that address the quality of pain symptoms; it is completed by the patient and no physical examination is required. A score ≤12 indicates that pain is unlikely to have a neuropathic component (< 15%), while a score of ≥19 suggests that pain is likely to have a neuropathic component (> 90%). An intermediate score (≥13, ≤18) indicates a possible neuropathic component .

  8. Patient satisfaction: numeric rating scale (NRS)

    Time frame: 10 years

    Patient satisfaction reported on 0-10 numeric rating scale (NRS) at 3, 6, 12, 24, 60 and 120 months using a questionnaire.

    The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating that patient is not satisfied at all and 10 reflecting that patient is totally satisfied.

  9. Post-operative nausea incidence

    Time frame: During Hospitalization, approximately 3 days

    incidence (on a 0-10 NRS) of nausea will be evaluated in the first post-operative days.

    The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no nausea and 10 reflecting the maximum intensity of nausea.

  10. Post-operative nausea intensity

    Time frame: During Hospitalization, approximately 3 days

    intensity (on a 0-10 NRS) of nausea will be evaluated in the first post-operative days.

    The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no nausea and 10 reflecting the maximum intensity of nausea.

  11. Post-operative opioids and analgesic drugs consumption

    Time frame: During Hospitalization, approximately 3 days

    Medication Quantification Scale (MQS) score will be used to evaluate analgesic drug consumption.

    Medication Quantification Scale (MQS) scor is calculated for each medication by taking a consensus-based detriment weight for a given pharmacologic class and multiplying it by a score for dosage. The calculated values for each medication are then summed for a total MQS score. The score can provide a useful point measure of medication usage for any pain medication regimen.

  12. Post-operative C-Reactive Protein (CRP)

    Time frame: every days 3 days from surgery

    Hematic C-Reactive Protein in mg/L will be evaluated as index of post-operative inflammatory response.

  13. Post-operative erythrocyte sedimentation rate (ESR)

    Time frame: every days 3 days from surgery

    Erythrocyte sedimentation rate (mm/h) will be evaluated as index of post-operative inflammatory response.

  14. Time from surgery to first mobilization

    Time frame: During Hospitalization, approximately 1 days

  15. Time needed for climbing stairs the first time

    Time frame: approximately 1 week

  16. Length of hospital stay

    Time frame: approximately 1 week

Other outcomes

  1. Number of patients with treatment-related adverse events

    Time frame: 10 years

    The safety of I.V. and I.A. dexamethasone supplementation will be evaluated in terms of: rate of serious adverse events related to steroid supplementation, rate of prosthetic joint infections, rate of wound infections, rate of wound healing problems.

    Furthermore, glycaemia will be evaluated daily during the first three days after surgery.

    To delineate a complete safety profile of dexamethasone supplementation, all treatment related adverse events will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Candrian, MD, Prof

CONTACT

[email protected]

+41 (0) 91 811 61 23

Marco Delcogliano, MD

CONTACT

[email protected]

+41 (0)91 811 66 56

Sponsors and collaborators

Lead sponsor

Christian Candrian

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2026
Study completion
2033
First posted
Jun 16, 2020
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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