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COSTI: COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty - A Triple Blinded, Randomized Controlled Trial Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Through a triple-blinded randomized control trial, the primary purpose of this pilot study is to assess the efficacy of administering peri-operative contralateral corticosteroid injection in patients undergoing TKA. The secondary outcome was to assess the effect of contralateral corticosteroid injection on pain and functional outcomes of patients undergoing TKA.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients 18 years of age and older

• Primary osteoarthritis diagnosis with indication for primary elective unilateral TKA

• No previous contralateral knee injections (steroids/biologics) within one year of study

• Not scheduled for bilateral TKA or a subsequent staged contralateral TKA within the next six months

• No previous or active infection or trauma (osseous/ligamentous/extensor mechanism) on the contralateral knee

• Contralateral knee pain \& symptoms - defined as a VAS of \>4/10 at initial pre-op visit

• Contralateral knee OA quantified as: Kellgren and Lawrence grade \>2-4

⁃ Assessed by PI (AK) who will not be contributing any patients to the study through examination of blinded knee radiographs (3 views: AP/lateral/Sunrise)

• Patient is able to read and understand English and provide informed consent to participation in the study

Locations
Other Locations
Canada
St. Michael's Hospital
RECRUITING
Toronto
Contact Information
Primary
Cassandra Tardif-Theriault, BKin
cassandra.tardif-theriault@unityhealth.to
416-864-6060
Time Frame
Start Date: 2025-01-24
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 60
Treatments
Experimental: Group A - Corticosteroid Injection
Corticosteroid injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL).~The patient will be brought to the regional room where a fully licensed anaesthesiologist will perform standard of care anaesthesia followed by an ultrasound guided intra-articular knee injection with steroid AFTER the spinal neuraxial blockage has already been administered.
Sham_comparator: Group B - Band-Aid Placement
The patient will be brought to the regional room where a fellowship trained interventional pain/regional anaesthesiologist will perform standard of care anaesthesia followed by the application of a band-aid.
Sponsors
Leads: Unity Health Toronto

This content was sourced from clinicaltrials.gov