Effect of Intravenous Hydrocortisone on Range of Motion After Total Knee Arthroplasty: A Randomized Placebo-Controlled Trial With Nested Case-Control Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Postoperative Range of Motion (ROM)
研究概览
简要总结
In this study, total knee replacement patients will be determined to be stiff or non-stiff preoperatively. Stiffness designation is determined by preoperative range of motion (if flexion is < 100 degrees, or extension lag is > 10 degrees). The stiff and non-stiff groups will both be randomized to two groups to receive either intravenous hydrocortisone or a placebo at 3 intervals postoperatively. Patients will be followed up with in hospital and via the phone on postoperative day (POD) 1 and 2, as well as 6 weeks, 6 months, 1 year, and 2 years postoperatively. Patients will also have blood drawn preoperatively in the OR, on POD1, at their 6 week followup, and at their 1 and 2 year follow ups. This blood will be processed and analyzed.
详细描述
TKA is the standard of care for treating patients suffering from end-stage knee arthritis and other disabling knee injuries. Indications have increased to ever younger patients and, combined with the aging US population, nearly 700,000 Americans receive TKAs each year. In spite of surgery, many patients experience persistent pain, stiffness or instability that negatively impacts their quality of life; up to 5% experience TKA failure in the first 10 years.
Presently, IV stress dose steroids is an accepted practice for bilateral knee replacement (BTKR) leading to decreased pain 24 hours after surgery and improved range of motion (ROM) on postoperative day 2 (POD2). These benefits are likely due to suppression of inflammation immediately after surgery. It is not clear if IV stress dose steroids improve ROM at later time points. Moreover, it is not clear if IV hydrocortisone improves clinical outcomes in unilateral TKA, where pain and joint stiffness remain significant challenges weeks after surgery. The investigators hypothesize that IV hydrocortisone will increase ROM at 6 weeks following surgery.
This study will enroll 132 patients that will be followed for up to 2 years. By integrating cell and molecular biology, biomechanics, and imaging technologies (including a CT scan at 1 year), this study is designed to comprehensively examine the long term effects of IV hydrocortisone on joint stiffness, pain, clinically relevant inflammatory states, and the synovium following unilateral TKA. Because subjects with variable ROMs will be enrolled in the study and followed over time, the findings may enable the development of biomarker prediction tools and the targeting of appropriate prevention and management measures for patients at highest risk of joint stiffness and subsequent surgical intervention.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective primary unilateral total knee arthroplasty
- •Osteoarthritis (OA) within the affected joint
- •Patients of surgeons who have agreed to participate in the study
- •Age ≥18 to 83 years
- •American Society of Anesthesiologists (ASA) Physical Status 1-3
- •Neuraxial Anesthesia
- •Adductor canal block (ACB), Interspace between the popliteal artery and capsule of the posterior knee (IPACK) block (unless valgus knee patient), and Periarticular Injection (PAI) for postoperative pain
排除标准
- •Contraindication to regional anesthesia, non-steroidal anti-inflammatory drugs, or steroids
- •Pre-operative oral steroid use in the past 3 months
- •Body mass index (BMI) greater than or equal to 45
- •Intraarticular steroid injections within two months of scheduled surgery in affected joint
- •Non-English speaking
- •Pre-existing diagnosis of rheumatic disease, autoimmune disease, or immunodeficiency (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type I diabetes)
- •Active infection
- •History of >6 weeks of daily opioid use and/or any use of non-prescribed opioids within one year
- •Pregnant women
- •Previous study participants in this study
- •Type II Diabetes on insulin
- •History of refractory postoperative nausea and vomiting (PONV) or PONV after sedation (can include if nausea only after general anesthesia)
- •Previous hardware in affected joint
- •Open Reduction and Internal Fixation (ORIF) surgery to affected joint
- •Cementless total knee arthroplasty (TKA)
研究组 & 干预措施
Stiffness Intravenous Hydrocortisone
Total knee replacement patients with preoperative knee stiffness (defined as flexion < 100 degrees or extension lag > 10 degrees) receive 3 doses of 100mg intravenous hydrocortisone every 8 hours. The first dose is given in the holding area approximately 2 hours prior to first incision.
干预措施: Hydrocortisone (Drug)
Stiffness Intravenous Placebo
Total knee replacement patients with preoperative knee stiffness (defined as flexion < 100 degrees or extension lag > 10 degrees) receive 3 doses of matched volume diluent every 8 hours. The first dose is given in the holding area approximately 2 hours prior to first incision.
干预措施: Dextrose 5% in water (D5W) (Drug)
Non-stiff Intravenous Hydrocortisone
Total knee replacement patients without preoperative knee stiffness (defined as flexion < 100 degrees or extension lag > 10 degrees) receive 3 doses of 100mg intravenous hydrocortisone every 8 hours. The first dose is given in the holding area approximately 2 hours prior to first incision.
干预措施: Hydrocortisone (Drug)
Non-stiff Intravenous placebo
Total knee replacement patients without preoperative knee stiffness (defined as flexion < 100 degrees or extension lag > 10 degrees) receive 3 doses of matched volume diluent every 8 hours. The first dose is given in the holding area approximately 2 hours prior to first incision.
干预措施: Dextrose 5% in water (D5W) (Drug)
结局指标
主要结局
Postoperative Range of Motion (ROM)
时间窗: 6 weeks postoperative (±2 weeks)
The primary outcome is range of motion at patients' 6 week (±2 weeks) postoperative surgeon appointment.
次要结局
- Numeric Rating Scale (NRS)(baseline (preoperative), postoperative day (POD) 1, POD2, 6 weeks postop, 1 year postop, 2 years postop)
- PainDETECT Neuropathic Pain Score(baseline (preoperative), 6 weeks postop, 1 year postop, 2 years postop)
- Postoperative Stiffness(6 weeks postoperative (±2 weeks))
- TIme to physical therapy goals completion(postoperative day 0-3)
- Knee injury and Osteoarthritis Outcome Score (KOOS Jr.)(Preoperative, 6 weeks, 6 months, 1 year, 2 years postoperative)
- Veterans Rand 12-item health survey (VR-12) score(preoperative, 6 weeks, 6 months, 1 year, 2 years postoperative)
- Opioid consumption(pre-surgical screening (PSS and holding area), day of surgery (DOS), POD1, POD2 at 6 weeks, 6 months 1 year and 2 years postoperatively,)
- Lower extremity Activity Survey (LEAS) scores(preoperative, 6 weeks, 6 months, 1 year, 2 years postoperative)
- Biomechanical findings(preoperative, 6 weeks, 1 year)
- Inflammatory state (via protein, ribonucleic acid (RNA), cellular, and tissue level analyses(Day of surgery (preoperative), postoperative day 1, postoperative week 6 (±2 weeks))
- MRI Findings(preoperative, 1 year, 2 years)