Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair

Mahidol University

Status and phase: Not yet enrolling; Phase 4

Conditions: Rotator Cuff Tears

Treatments: Drug: N-acetyl cysteine; Other: placebo; Drug: Ascorbic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06384833

Rama

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

110 participants in 2 patient groups, including a placebo group

Ascorbic Acid and N-acetylcysteine

Experimental group

Description:

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

Treatment:

Drug: Ascorbic acid

Drug: N-acetyl cysteine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo