Rotator Cuff Tears
Conditions
Keywords
Ascorbic acid, Acetylcysteine, Rotator cuff repair
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.
Interventions
DRUGAscorbic acid
Vitamin C (solution) 500 mg IV q4h for 4 doses PO d0 Vitamin C (tablet) 100mg 5 tab PO BID for 45 days
DRUGN-acetyl cysteine
NAC (effervescent) 600mg 1 tab PO OD for 45 days
OTHERplacebo
pharmacologically inactive substance
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ASES score | 6 months after surgery | American Shoulder and Elbow Surgeons (ASES) Shoulder Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed