Gut Microbiome in Orthopaedics: Effect of Probiotics on Initial Implant Migration and Joint Inflammation After Total Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Implant Migration
研究概览
简要总结
Patients having knee replacement surgery regularly experience joint pain and compromised bone quality leading to implant loosening and periprosthetic fractures. The role of the gut microbiome, which is the collection of bacteria and other microbes within the human gastrointestinal tract, is just beginning to be recognized, including its potential effects on pain, infection, and loosening after total joint replacement. Antibiotics are regularly used in orthopaedic surgery to reduce the risk of infection, but they also harm gut microbiota and reduce their potentially beneficial effects. Probiotics may have a role to play in enhancing bone quality and decreasing synovial inflammation after joint replacement surgery, and this study will explore the potential relationship of probiotic use with implant migration, bone density, and patient outcomes.
This study is a randomized, controlled, double-blinded trial comparing probiotic use with placebo in post-menopausal women undergoing primary total knee replacement. The main questions it aims to answer are:
- to compare implant migration between groups from baseline to six weeks post-surgery
- to compare bone density and joint inflammation between groups from baseline to six weeks post-surgery
- to compare gut microbiome composition and patient-reported outcome measures between groups from baseline to six weeks post-surgery
详细描述
Participants will take a daily probiotic (DE111®) or placebo once daily starting 3 weeks prior to surgery until six weeks after surgery. The following will be completed at baseline and 6 weeks:
- Bloodwork
- Fecal sample collection
- MRSA swab
- Patient-reported outcome measures
- CT imaging scan
In addition, the following will be done:
- Intraoperative fluid and tissue collection
- Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI) scan at 6 weeks post-surgery
Researchers will compare the probiotic and placebo groups for any significant differences in implant stability, bone quality, inflammation, gut microbiome composition, and pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent obtained prior to any study-related activities
- •Postmenopausal female patients of London Health Sciences Centre (LHSC) aged 55-75 years
- •Scheduled to undergo primary total knee replacement for osteoarthritis
排除标准
- •Unable to understand and respond to the provided questionnaires
- •Inflammatory arthritis
- •Periprosthetic infection
- •Prior surgery with hardware insertion in the target knee
- •Metabolic syndrome
- •Inflammatory bowel disease
- •Body mass index <18.5 kg/m2
- •Immune-compromised condition (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment)
- •Any contraindications for PET-MRI
- •Allergy to cephalosporin antibiotics
结局指标
主要结局
Implant Migration
时间窗: baseline, 6 weeks
Tibial component migration over time calculated by measuring the position of the component compared to the bone using CT imaging.
次要结局
- Bone Density(baseline, 6 weeks)
- Magnitude of 18-F-Fluoroethyl(2-(2-fluoroethoxy)phenyl)-proprionate ([¹⁸F]FEPPA) Tracer Uptake(6 weeks)
研究者
Brent Lanting
Orthopaedic surgeon
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's