NCT03355651已完成不适用
Prospective Study for Assess Efficacy and Tolerability of an Oral Supplement Based on Collagen, HC-15 and Plasmatic Proteins, in the Recovery of ACL After Surgery: a Multicenter, Randomized, Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Pain improvement
研究概览
简要总结
This was a prospective, multicenter, randomized, open-label, phase IV trial to compare the efficacy of supplementation with plasma proteins, hydrolyzed collagen (CH), a complex of HA-CS (HC-15), and vitamin C combined with a standard rehabilitation protocol versus the standard rehabilitation protocol only after arthroscopically-assisted functional ACL reconstruction with hamstrings.
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
- Single (Outcomes Assessor)
盲法说明
ACL parasagittal cuts were performed in T1 sequences and analyzed by a blinded musculoskeletal radiologist to improve the quality of the study
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 18 and 55 years with partial or complete anterior cruciate ligament (ACL) rupture, diagnosed clinically and by Magnetic Resonance Imaging (MRI), requiring reconstructive surgery.
- •Patients with symptoms of acute or subacute ACL rupture (such as inflammation of the knee and pain with leg movement) or chronic ACL tear, including instability of the knee.
- •Patients with ACL ruptures without osteochondral lesions requiring additional surgery.
- •Patients with a medical history of therapeutic benefit using analgesic agents.
排除标准
- •Patients with concomitant osteochondral pathology.
- •Patients treated with intra-articular injections of corticosteroids and/or platelet-rich plasma, or with oral glucosamine, CS, HA or CH in the two months prior to surgery.
- •Patients with systemic diseases, those treated with antibiotics or other drugs that might alter the healing process, and those who had undergone arthroscopic lavage in the 90 days prior to surgery.
研究组 & 干预措施
PROGEN Group
Active Comparator
PROGEN + Standard Rehabilitation + ACL reconstruction
干预措施: PROGEN (Dietary Supplement)
Control Group
No Intervention
Standard Rehabilitation + ACL reconstruction
结局指标
主要结局
Pain improvement
时间窗: 90 days
Assessed using a 100-mm Visual Analog Scale (VAS)
次要结局
- Number of rehabilitation sessions required(90 days)
- Maduration of the graft(Day 0, day 90)
- Knee function(90 days)
- Analgesic consumption(90 days)
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