A Single-center Observational Study of the Relationship Between Sleep, Synovial Fluid Cytokine Profiles, & Outcomes of ACL Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Knee injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
This is an observational study of the relationship between perioperative sleep time/quality, synovial fluid cytokine profiles, and clinical outcomes of primary ACL reconstruction with BPTB autograft in 50 subjects. Sleep during the week before and month after surgery will be assessed using Fitbit smartwatch and sleep diary. Synovial fluid sampled preoperatively, intraoperatively, and postoperatively will be analyzed for levels of pro- and anti-inflammatory cytokines. Postoperative knee pain and function will be assessed until 2 years post-op using validated questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Undergoing primary ACL reconstruction with BPTB autograft for acute ACL tear, with or without concomitant meniscectomy
- •Presenting within 2 weeks of injury and undergoing reconstruction within 8 weeks of injury
排除标准
- •History of blood-borne diseases including HIV, HBV, HCV, HTLV, or syphilis
- •Multiligamentous knee injury
- •Concomitant meniscal repair, meniscal allograft transplantation, osteotomy, or repair of focal chondral defect (e.g., osteochondral autograft transfer system, osteochondral allograft, matrix-induced autologous chondrocyte implantation)
- •Prior ipsilateral knee surgeries or injuries
- •Primary sleep disorders including insomnia, sleep apnea, or restless legs syndrome
- •Uncontrolled psychiatric disorders with sleep disturbance
- •Night shift work
- •Travel with time zone change within three weeks of surgery
- •Systemic inflammatory disease
- •Autoimmune disease
- •Immunomodulatory drug use
- •Chemotherapy within a year before surgery
- •Intra-articular injection within 3 months before surgery
结局指标
主要结局
Knee injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Year 2
KOOS is a survey is meant to track how the participant feels about their knee and how well they are able to perform their usual activities. There are six categories in the survey: Symptoms, Stiffness, Pain, Function/Daily Living, Function/Sports, Quality of Life. 1. Symptoms category consists of 5 questions, ranked from "never" to "always" (0-5). 2. Stiffness category consists of 2 questions, ranked from "none" to "extreme" (0-5). 3. Pain category consists of 9 questions, ranked from "none" to "extreme" (0-5). 4. Function/Daily Living category consists of 17 questions, ranked from "none" to "extreme" (0-5). 5. Function/Sports category consists of 5 questions, ranked from "none" to "extreme" (0-5). 6. Quality of Life category consists of 4 questions, ranked from "not at all" to "extremely, constantly, totally" (0-5). The total range of score is 0-210. The lower the score, the better they feel about their knee and performance of usual activities.
次要结局
- Score on Lysholm Knee Scoring Scale(Year 2)
- Knee Range of Motion(Year 1)
- Thigh Circumference(Year 1)
- Concentration of Synovial Fluid Cytokines(Year 1)
- VAS Score for Anterior Knee Pain(Year 2)