Muscle Weakness and Post-traumatic Knee OA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score
研究概览
简要总结
This is a single-center, randomized, single-blind (evaluator) study. Enrolled patients had a traumatic meniscal tear and underwent meniscectomy. The study included 6 weeks (12 visits) of standard or quadriceps intensive rehabilitation. The objective of the study was to determine the effect of quadriceps intensive rehabilitation on knee function and articular cartilage.
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)
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •traumatic onset meniscal tear (i.e. specific mechanism of injury)
- •meniscectomy surgery performed within 12 months of index injury
- •meniscal tear confirmed at the time of surgery
- •subject anticipates living in close proximity to Gainesville for one year following surgery.
排除标准
- •bilateral injury
- •concomitant ligamentous injury
- •previous knee injury
- •articular cartilage defect > Grade II on Outerbridge scale
- •patellofemoral joint pain > 3/10 with activity
- •lower limb alignment > 5 degrees of valgus or varus
- •contraindication to an MR examination including: a pacemaker, metal implants which are not MR compatible, pregnancy and severe claustrophobia.
结局指标
主要结局
Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score
时间窗: Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)
The IKDC is a measure of self-reported knee function and includes items related to symptoms and functional activity. Responses on the IKDC subjective knee form will be recorded on hard-copy and the summary score computed. The highest (best) possible score is 100 points and the lowest (worst) possible score is 0 points.
Change in Tibial Articular Cartilage Volume
时间窗: Baseline (pre-surgery) to 1 year post-surgery
A magnetic resonance image (MRI) of the knee will be acquired and software will be used to quantify tibial articular cartilage volume.
次要结局
- Single Leg Forward Hop Index(7 weeks post-surgery (post-intervention))
- Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)(Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention))