Status:
RECRUITING
Perioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
The Arthritis Society, Canada
Conditions:
Chronic Pain
Knee Pain Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase II Multicentre, pilot, parallel-group, blinded, 1:1 randomized controlled trial to determine the feasibility of conducting a larger definitive trail of using vitamin C to reduce persistent pain ...
Detailed Description
PROVISION is a multicentre, pilot, parallel-group, blinded, randomized controlled trial of 300 patients undergoing total knee arthroplasty surgery. Consented eligible patients will be randomized to re...
Eligibility Criteria
Inclusion
- Patients \>18 years old
- Undergoing a unilateral or bilateral primary total knee arthroplasty for advanced osteoarthritis of the knee
Exclusion
- TKA for infection (septic joint), fracture, ankylosing spondylitis, lupus, or psoriatic arthritis
- History of kidney stones, acute or chronic renal failure, hemochromatosis, or glucose-6-phosphate deficiency
- Unlikely to comply with follow-up (e.g., no fixed address, plans to move out of town)
- Language difficulties that would impede valid completion of questionnaires
- Planned staged bilateral TKA
- Treating surgeon deems patient inappropriate for inclusion in trial
- Any allergy or sensitivity to milk
- Pregnant or planning to become pregnant during the study
Key Trial Info
Start Date :
April 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06123715
Start Date
April 16 2024
End Date
December 31 2026
Last Update
April 25 2025
Active Locations (3)
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1
Sunnybrook - Holland Centre
Toronto, Ontario, Canada, M4Y 1H1
2
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
3
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8