Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair: A Triple-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- ASES score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Ascorbic acid (Drug)
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
干预措施: N-acetyl cysteine (Drug)
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
干预措施: placebo (Other)
结局指标
主要结局
ASES score
时间窗: 6 months after surgery
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
次要结局
- UCLA shoulder scale(6 months after surgery)
- WORC index(6 months after surgery)
- Tendon healing at 6 months postoperatively(6 months after surgery)