Perioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty

NCT06123715 | Recruiting Phase 2

• 1 other identifier: 23-5642
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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 in patients undergoing total knee arthroplasty surgery.

Conditions

Chronic Pain; Knee Pain Chronic; Post Operative Pain

Outcome Measures

Primary Outcomes (3)

• Study will determine feasibility of enrolling, recruiting, and follow-up with patients.

  The study will assess the feasibility of enrolling, recruiting, and following-up with patients undergoing a primary total knee arthroplasty (TKA) through active monitoring of recruitment/enrollment rates on a monthly basis for a total of one year using excel trackers. The follow-up rate of patients will be assessed at 12 months based on completion of all 12 month questionnaires.

  12 months

• Clinical site compliance

  Clinical site compliance with trial protocol will be determined based on number of protocol deviations at each site as logged on the deviation logs. This will be assessed on a monthly basis for a full year to maintain active monitoring of compliance.

  12 months

• Resource Assessment

  This pilot study will help determine the resources required for larger definitive trial based on critical analysis of recruitment trackers to assess time spent on recruitment/enrollment.

  12 months

Secondary Outcomes (10)

• Prevalence of persistent pain

  3 months and 12 months

• Qualities and characteristics of persistent pain

  3 months and 12 months

• Persistent Neuropathic Pain

  3 months and 12 months

• Acute and chronic analgesic consumption

  Day of surgery, post-operative day 1-3, 3 months, and 12 months

• Development of Complex Regional Pain Syndrome (CRPS)

  3 months and 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Preoperative Vitamin C capsules

Drug: Vitamin C

Placebo

PLACEBO COMPARATOR

Preoperative placebo capsules

Drug: Placebo

Interventions

Vitamin C DRUG

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.

Also known as: Ascorbic Acid

Intervention

Placebo DRUG

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.

Also known as: Lactose (Monohydrate)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 years old
• Undergoing a unilateral or bilateral primary total knee arthroplasty for advanced osteoarthritis of the knee

You may not qualify if:

• 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
• Any allergy or sensitivity to milk
• Pregnant or planning to become pregnant during the study

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Arthritis Society, Canada: collaborator

Study Sites (3)

Sunnybrook - Holland Centre

Toronto, Ontario, M4Y 1H1, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Pain, Postoperative

Interventions

Ascorbic Acid; Lactose

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Disaccharides; Oligosaccharides; Polysaccharides; Sugars

Study Officials

• James Khan, MD

  University Health Network; Department of Anesthesia and Pain Medicine

  PRINCIPAL INVESTIGATOR

• Raman Mundi, MD

  Holland Orthopedic and Arthritic Centre

  PRINCIPAL INVESTIGATOR

• Harman Chaudhry, MD

  Holland Orthopedic and Arthritic Centre

  PRINCIPAL INVESTIGATOR

• Jesse Wolfstadt, MD

  Mount Sinai Hospital; Department of Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Khan, MD

CONTACT

416-340-4800; James.Khan@medportal.ca

Nour Ayach

CONTACT

(416) 340 4800; Nour.Ayach@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: November 9, 2023
• Study Start: April 16, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)