Prospective Randomized Study Evaluating Clinical Effectiveness of Post-op Treatment With Hyaluronic Acid Injections in Degenerative Joint Disease & Meniscal Tears
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Tegner Activity Level Scale Score
研究概览
简要总结
This study will look at patients with post-operative treatment of a meniscal tear or degenerative joint disease (degenerative arthritis). They will be randomized into one of three groups: Euflexxa injection, saline (placebo) injection, or no injection. Those who are randomized into the injection group will receive a series of three injections (one a week for 3 weeks), then a "booster" injection at 6 months post-op. Several questionnaires will be given after the first set of injections, then again at a one year follow-up.
The hypothesis is that patients receiving hyaluronic acid injections will have better pain and function scores as compared with placebo and no further treatment at all time points.
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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in post-op stage of treatment for meniscal tears or chondropathy/DJD
- •Over 40 years of age
- •A daily knee pain above 20mm on a 100mm visual analogue scale
排除标准
- •Previous recipient of viscosupplementation injections
- •Had rheumatoid arthritis or other inflammatory arthritis
- •Had intra-articular steroid injections within the previous 2 months
- •Invasive knee procedures within the past 6 months
- •Contraindications to hyaluronate (an allergy)
- •Medications that could interfere with the planned interventions
研究组 & 干预措施
Viscosupplementation
Hyaluronic acid injection
干预措施: Euflexxa (Device)
Saline injection
干预措施: Saline (Other)
结局指标
主要结局
Tegner Activity Level Scale Score
时间窗: 1 yr postop
The Tegner Scoring system is a numeric scale range from 1 to 10, with each value indicating the ability to perform a specific activity. The scoring system is ordinal in nature and reflects lower to higher levels of activity participation, with higher numbers indicating a higher level of function.
次要结局
未报告次要终点