Intra-operative ACP Injection Following Partial Meniscectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in IKDC (International Knee Documentation Committee) score over the various follow-up times
研究概览
简要总结
The aim of the present double blind controlled study is to evaluate the effects in terms of pain control and functional recovery provided by a single intra-operative injection of ACP performed at the end of arthroscopic partial meniscectomy.
Patients included in this trial will be randomized in two treatment groups: the first one will receive a single injection of 3-5 cc of ACP (using a dedicated centrifuge) at the end of the arthroscopic meniscectomy, whereas the second group will be treated by surgery alone. In order to ensure the double blinding of the trial all the patients enrolled will undergo blood harvesting before anesthesia, and acp will be produced just for the patients included in ACP group.
All patients will be evaluated basally, and then at 15, 30, 60, and 180 days after surgery by the following evaluation tools: IKDC (International Knee Documentation Committee) subjective, VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the operated and contralateral knee were documented; also in addition, the trans-patellar circumference of both knees was registered to assess the trend of knee swelling over time.
Drugs assumption during the follow-up period will be recorded for each patient. All eventual adverse events occurred during the follow-up period will be registered.
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
- Double (Participant, Outcomes Assessor)
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
- •chronic symptomatic meniscal tears requiring partial resection;
- •healthy contra-lateral knee (i.e. no pain or functional limitation in the contra-lateral joint);
排除标准
- •meniscal lesions requiring suture;
- •previous surgery on the index knee;
- •other concurrent articular lesion requiring surgical treatment (e.g.: cartilage or ligament injuries);
- •history of knee infectious arthritis;
- •concurrent rheumatic, metabolic or severe systemic disease;
- •Body Mass Index (BMI) > 30;
- •known hypersensibility or allergy to/towards HA ;
- •alcohol or other substances abuse/excess.
结局指标
主要结局
Change in IKDC (International Knee Documentation Committee) score over the various follow-up times
时间窗: basal, 15,30,60,180 days
Change in VAS( Visual Analogue score) for pain over the various follow-up times
时间窗: basal, 15,30,60,180 days
次要结局
- Change in transpatellar circumference over time(basal, 15,30,60,180 days)
- Change in Tegner Score over the various follow-up times(basal, 30,60,180 days)
- Change in active and passive ROM(basal, 15,30,60,180 days)
- Adverse events report(180 days after surgery)
- Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) over the various follow-up times(basal, 15,30,60,180 days)
- Change in VAS for general health status(basal, 30,60,180 days)