Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair: A Triple-blinded, Randomized Controlled Trial

Rama

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.

2024-05-01

2025-09-01

2026-05-01

Not yet recruiting

Early phase I

110

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}

2024-04-25