Early Viscosupplementation After Partial Meniscectomy: a Double Blind, Placebo Controlled Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in IKDC (International Knee Documentation Committee) score
研究概览
简要总结
The rational of intra-articular viscosupplementation is based on both the biological and mechanical properties of HA, which exerts positive effects on the modulation of the entire joint environment.
The aim of the present double blind controlled study was to evaluate the effects in terms of pain control and functional recovery provided by a single intra-operative injection of HA performed at the end of arthroscopic partial meniscectomy.
Patients included in this trial were randomized in two treatment groups: the first one received a single injection of HA (Hymovis 24 mg/3ml, Fidia Farmaceutici Spa, Padova, Italy) at the end of the arthroscopic meniscectomy, whereas the second group was treated by surgery alone.
All patients were evaluated basally, 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.
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 50 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
- •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.
研究组 & 干预措施
meniscectomy alone
Arthroscopic meniscectomy alone
干预措施: meniscectomy alone (Procedure)
Hyaluronic acid group
Single injection of 3 ml HA (Hymovis, Fidia Farmaceutici SpA, Padova, Italy) at the end of the arthroscopic meniscectomy
干预措施: hyaluronic acid (Biological)
结局指标
主要结局
Change in IKDC (International Knee Documentation Committee) score
时间窗: basal, 15,30,60,180 days
次要结局
- Change in Tegner Score(basal, 15,30,60,180 days)
- Change in KOOS (Knee Injury and Osteoarthritis Outcome Score)(basal, 15,30,60,180 days)
- Change in VAS (Visual Analogue Scale) for pain(basal, 15,30,60,180 days)
- Change in EQ-VAS for general health(basal, 15,30,60,180 days)
- Change in transpatellar circumference over time(basal, 15,30,60,180 days)
- Change in active and passive ROM(basal, 15,30,60,180 days)
- Adverse events report(60 days)
- Adverse events report(15 days)
- Adverse events report(30 days)
研究者
Federica Balboni
BScD
Istituto Ortopedico Rizzoli