Clinical trial NCT06384833: Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair
Official title: Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair: A Triple-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Rotator Cuff Tears
Keywords: Ascorbic acid
Acetylcysteine
Rotator cuff repair
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: ASES score
timeFrame: 6 months after surgery
Secondary outcomes:
measure: UCLA shoulder scale
timeFrame: 6 months after surgery
measure: WORC index
timeFrame: 6 months after surgery
measure: Tendon healing at 6 months postoperatively
timeFrame: 6 months after surgery
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.
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.