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NCT06384833 Clinical Trial

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

Rotator Cuff Tears Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06384833
Other study ID # Rama
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date May 1, 2024
Est. completion date May 1, 2026

Study information
Verified date April 2024
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 110
Est. completion date May 1, 2026
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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
• N-acetyl cysteine
NAC (effervescent) 600mg 1 tab PO OD for 45 days
Other:
• placebo
pharmacologically inactive substance

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

References & Publications (3)

Gilat R, Atoun E, Cohen O, Tsvieli O, Rath E, Lakstein D, Levy O. Recurrent rotator cuff tear: is ultrasound imaging reliable? J Shoulder Elbow Surg. 2018 Jul;27(7):1263-1267. doi: 10.1016/j.jse.2017.12.017. Epub 2018 Feb 3. — View Citation

Martel M, Laumonerie P, Girard M, Dauzere F, Mansat P, Bonnevialle N. Does vitamin C supplementation improve rotator cuff healing? A preliminary study. Eur J Orthop Surg Traumatol. 2022 Jan;32(1):63-70. doi: 10.1007/s00590-021-02926-0. Epub 2021 Mar 16. — View Citation

Uehara H, Itoigawa Y, Morikawa D, Koga A, Tsurukami H, Maruyama Y, Ishijima M. The Effect of Vitamin C and N-Acetylcysteine on Tendon-to-Bone Healing in a Rodent Model of Rotator Cuff Repair. Am J Sports Med. 2023 May;51(6):1596-1607. doi: 10.1177/03635465231160772. Epub 2023 Apr 5. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary ASES score American Shoulder and Elbow Surgeons (ASES) Shoulder Score 6 months after surgery
Secondary UCLA shoulder scale The University of California-Los Angeles (UCLA) shoulder scale 6 months after surgery
Secondary WORC index Western Ontario Rotator Cuff Index 6 months after surgery
Secondary Tendon healing at 6 months postoperatively Sugaya ultrasound classification 6 months after surgery
See also
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Completed NCT04710966 - Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears N/A
Recruiting NCT06192459 - Effect of the Muscle Strength and Range of Motion Training for Post-platelet Rich Plasma Injection in People With Rotator Cuff Partial Tear N/A
Recruiting NCT05925881 - Lower Trapezius Transfer vs Bridging Reconstruction N/A
Recruiting NCT05988541 - Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair. N/A
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