Perioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty
NCT ID: NCT06123715
Last Updated: 2025-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2024-04-16
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Intervention
Preoperative Vitamin C capsules
Vitamin C
Drug: Patients in the intervention group will receive 2g Vitamin C orally within 4 hours of the start of the surgery followed by 500 mg of Vitamin C to be taken orally twice a day from post-op day1 to day 56.
Placebo
Preoperative placebo capsules
Placebo
Drug: Patients in the placebo group will receive identical placebo capsules taken orally within 4 hours of the start of the surgery followed by placebo capsules taken orally twice a day from post-op day 1 to day 56.
Interventions
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Vitamin C
Drug: Patients in the intervention group will receive 2g Vitamin C orally within 4 hours of the start of the surgery followed by 500 mg of Vitamin C to be taken orally twice a day from post-op day1 to day 56.
Placebo
Drug: Patients in the placebo group will receive identical placebo capsules taken orally within 4 hours of the start of the surgery followed by placebo capsules taken orally twice a day from post-op day 1 to day 56.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing a unilateral or bilateral primary total knee arthroplasty for advanced osteoarthritis of the knee
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
The Arthritis Society, Canada
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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James Khan, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network; Department of Anesthesia and Pain Medicine
Raman Mundi, MD
Role: PRINCIPAL_INVESTIGATOR
Holland Orthopedic and Arthritic Centre
Harman Chaudhry, MD
Role: PRINCIPAL_INVESTIGATOR
Holland Orthopedic and Arthritic Centre
Jesse Wolfstadt, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Hospital; Department of Surgery
Locations
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Sunnybrook - Holland Centre
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-5642
Identifier Type: -
Identifier Source: org_study_id
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