Design of a Randomized Controlled Trial Examining the Effects of Arthroscopic Debridement on Chondral Lesions in Patients Undergoing Partial Meniscectomy: The ChAMP (Chondral Lesions And Meniscus Procedures) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Self-reported knee pain
研究概览
简要总结
The purpose of this randomized controlled trial is to determine the effectiveness of treating cartilage lesions found during knee arthroscopy.
详细描述
Normal wear-and-tear on the knee can cause tissue, or cartilage, in the knee to soften over time forming chondral lesions. Worn out cartilage is often found during knee surgery for other conditions. Typically, surgeons will remove any worn out cartilage that is found using a procedure called debridement. However, the investigators do not know if surgically treating the worn out cartilage is better than leaving the tissue untreated, so it is necessary to compare the two. Patients who are found to have worn out cartilage during arthroscopy, will be randomly assigned to either receive treatment (debridement) or non-treatment (observation) of their cartilage. Patients without worn out cartilage will also be included in this study and observed postoperatively.
The primary objective of this study is to examine the effects of treatment of worn out cartilage (versus non-treatment of worn out cartilage and versus patients without worn out cartilage), on self-reported knee pain following arthroscopic meniscectomy using a double-blinded randomized controlled trial design. Secondary objectives of this study include examining the effects of treating worn out cartilage on other outcomes (subjective knee and general health scores and knee measurements including range of motion, presence of effusion and quadriceps circumference) and also to calculate the intra-operative costs associated with treatment, including the amount of time and instruments needed for debridement.
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
- 30 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo a meniscectomy
- •Patients with chondral lesions found during meniscectomy
- •Patients without chondral lesions are not eligible for randomization to one of the study arms, but will still be included in the study and observed after surgery
排除标准
- •Osteochondritis dissecans
- •Large chondral flaps judged to be impending loose bodies
- •Joint space loss of affected compartment greater than 50% compared to opposite side
- •Visible osteophytes of the medial or lateral compartment
- •Previous knee surgery on the affected side
- •Previous major knee trauma
- •History of inflammatory joint disease, gout, or chondrocalcinosis
- •Presence of worker's compensation claim
- •Patients undergoing meniscal repair
- •Patients undergoing microfracture for contained grade IV chondral lesions
- •Presence of significant ligamentous instability in the operative knee (i.e., complete acruciate ligament (ACL) or posterior cruciate ligament (PCL) tear, grade III medial or lateral side instability)
- •Major neurologic deficit
- •Serious medical illness with limited life expectancy or that poses high intraoperative risk
- •Pregnancy
研究组 & 干预措施
Control Group
Worn out cartilage will be observed, but will not be treated surgically.
Treatment Group
Worn out cartilage will be surgically treated.
干预措施: Arthroscopic debridement (Procedure)
结局指标
主要结局
Self-reported knee pain
时间窗: 1-year after surgery
次要结局
- Intra-operative costs associated with debridement (i.e., time and instruments needed to debride)(Measured during surgery)
- Subjective measures and knee measurements(1-year after surgery)
研究者
Leslie Bisson
Principal Investigator
State University of New York at Buffalo
