Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair
- Conditions
- Rotator Cuff Tears
- Interventions
- Registration Number
- NCT06384833
- Lead Sponsor
- Mahidol University
- Brief Summary
The goal of this clinical trial is to learn if vitamin C and N-acetylcysteine work to improve shoulder functional score after rotator cuff repair. It will also learn about the safety of vitamin C and N-acetylcysteine. The main questions it aims to answer are:
Do vitamin C and N-acetylcysteine improve the shoulder functional score of participants? Do vitamin C and N-acetylcysteine improve healing of rotator tendon? Researchers will compare vitamin C and N-acetylcysteine to a placebo (a look-alike substance that contains no drug) to see if vitamin C and N-acetylcysteine works to improve shoulder functional score after rotator cuff repair.
Participants will:
Take vitamin C and N-acetylcysteine or a placebo every day for 45 days. Visit the OPD three times at 2 week, 6 month and 12 month after surgery for checkups and tests.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 110
- All patient who undergone arthroscopic primary rotator cuff complete repair.
- Clinical history and symptom consistent with rotator cuff tear.
- MRI confirmation of rotator cuff tear.
- Non-reparable or partial rotator cuff repair.
- High grade fatty degeneration of the rotator cuff (Goutallier III, IV)
- At least one torn tendon with retraction to the glenoid (stage 3 of Patte classification)
- Rotator cuff retear.
- Isolated subscapularis tear.
- Patient who loss follow up.
- Patent who cannot respond questionnaire.
- Patient who allergy to vitamin C or N-acetylcysteine.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ascorbic Acid and N-acetylcysteine N-acetyl cysteine Vitamin C 500 mg IV q4h for 4 doses PO d0 N-acetylcysteine 600mg 1 tab PO OD for 45 days Vitamin C 100mg 5 tab PO BID for 45 days Placebo placebo Placebo of vitamin C (0.9%NaCl) 100 ml IV q4h for 4 doses PO day0 Placebo of N-acetylcysteine 1 tab PO OD for 45 days Placebo of Vitamin C 5 tab PO BID for 45 days Ascorbic Acid and N-acetylcysteine Ascorbic acid Vitamin C 500 mg IV q4h for 4 doses PO d0 N-acetylcysteine 600mg 1 tab PO OD for 45 days Vitamin C 100mg 5 tab PO BID for 45 days
- Primary Outcome Measures
Name Time Method ASES score 6 months after surgery American Shoulder and Elbow Surgeons (ASES) Shoulder Score
- Secondary Outcome Measures
Name Time Method UCLA shoulder scale 6 months after surgery The University of California-Los Angeles (UCLA) shoulder scale
WORC index 6 months after surgery Western Ontario Rotator Cuff Index
Tendon healing at 6 months postoperatively 6 months after surgery Sugaya ultrasound classification