A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation
ConditionTotal Knee Replacement
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50-85
SponsorChristian Candrian
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Contraindications to steroids.
Revision TKA.
Active steroid therapy.
Women who are pregnant or breast feeding.
Trial design
Design model
Parallel
Treatments tested in this trial
Dexamethasone Sodium Phosphate 4 mg/ml intravenous
DrugPerioperative intravenous injection of 3 ml of solution (9mg of dexamethasone)
Dexamethasone Sodium Phosphate 4 mg/ml intra-articular
DrugPerioperative intra-articular injection of 3 ml of solution (9mg of dexamethasone)
Treatment groups
159 Participants
are divided into 3 treatment groupsGroup A: arm-A Intra-venous dexamethasoneExperimental treatment 1 intervention
Group B: arm-B intra-articular dexamethasoneExperimental treatment 1 intervention
Group C: arm-C routineNo intervention 0 interventions
Trial outcomes
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.
Time frame
3 days after surgerySecondary outcomes
1
Post-operative knee pain during the first 6 weeks after surgery on a 0-10 numeric rating scale
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.
Time frame
6 weeks after surgery2
Post-operative knee pain during the first 10 years after surgery
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.
Time frame
10 years3
Post-operative function during the first 6 weeks after surgery
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.
Time frame
6 weeks4
Post-operative knee function during the first 10 years after surgery
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.
Time frame
10 yearsOther outcomes
1
Number of patients with treatment-related adverse events
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.
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Christian Candrian
Lead sponsor
Ente Ospedaliero Cantonale, Bellinzona
Sponsor institution
Source ClinicalTrials.gov