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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Ascorbic Acid and N-acetylcysteine

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

Group Type EXPERIMENTAL

Ascorbic acid

Intervention Type DRUG

Vitamin C (solution) 500 mg IV q4h for 4 doses PO d0 Vitamin C (tablet) 100mg 5 tab PO BID for 45 days

N-acetyl cysteine

Intervention Type DRUG

NAC (effervescent) 600mg 1 tab PO OD for 45 days

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

pharmacologically inactive substance

Interventions

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Ascorbic acid

Vitamin C (solution) 500 mg IV q4h for 4 doses PO d0 Vitamin C (tablet) 100mg 5 tab PO BID for 45 days

Intervention Type DRUG

N-acetyl cysteine

NAC (effervescent) 600mg 1 tab PO OD for 45 days

Intervention Type DRUG

placebo

pharmacologically inactive substance

Intervention Type OTHER

Other Intervention Names

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Vitamin C NAC

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No