Adjunctive Use of Corticosteroid in Periarticular Injections in Primary Total Knee Arthroplasty
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- The primary outcome is to determine whether total knee arthroplasty outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone.
研究概览
简要总结
The goal of this clinical trial is to find out which type of steroid medicine, when added to a standard pain-control injection during total knee replacement surgery, works best at reducing pain, limiting opioid use, and improving recovery in adults undergoing surgery for severe knee arthritis or injury.
The main questions it aims to answer are:
Does adding a steroid to the injection improve pain control and reduce opioid use after surgery? Is the newer extended-release steroid (Zilretta) more effective and safer-especially for patients with diabetes-than the traditional steroid (methylprednisolone)?
Researchers will compare:
Standard pain-control injection alone Standard injection plus methylprednisolone Standard injection plus Zilretta to see which option provides better pain relief, less opioid use, and improved knee function.
(Patients with diabetes or prediabetes will only be in the standard injection or Zilretta groups so researchers can study whether Zilretta is safer for blood sugar control.)
Participants will:
Be randomly assigned to one of the study groups during their total knee replacement surgery Receive the assigned pain-control injection around the knee joint
Be followed after surgery to measure:
Pain levels Opioid pain medication use Knee movement (range of motion) Whether another procedure (such as manipulation under anesthesia) is needed if the knee becomes too stiff Patient-reported outcome surveys about pain and function
详细描述
Total knee replacement surgery (also called total knee arthroplasty, or TKA) is a common procedure for people with severe knee arthritis or injury. While the surgery often leads to significant pain relief and improved mobility, the days and weeks afterward can be uncomfortable. Managing pain during recovery is important-not just to make patients feel better, but also to help them move their knee sooner, avoid excessive use of opioid medications, and get back to normal activities faster.
One common pain management tool is called a pericapsular injection (PAI). This is a mixture of medications injected around the knee joint during surgery to help control pain after the operation. PAIs usually include a long-lasting numbing medicine, an anti-inflammatory drug, and sometimes other medications that improve pain relief. Corticosteroids-powerful anti-inflammatory drugs-are sometimes added, but the best type of steroid and the ideal way to give it is still debated among doctors.
Why This Study Is Being Done This study will compare two types of corticosteroids, methylprednisolone (a traditional steroid) and Zilretta (a newer, extended-release form of the steroid triamcinolone), to see which works better when added to the standard PAI. Zilretta releases medication slowly over time, which may lead to longer-lasting pain control and fewer side effects such as temporary increases in blood sugar-something especially important for people with diabetes.
How the Study Works
Patients having total knee replacement will be randomly placed into one of three groups:
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 (Participant)
盲法说明
Research participants will be randomized to one of three groups unless they are diabetic or pre-diabetic then they will be randomized to one of 2 groups (Group 1 or Group 3). Participants will not know to which group they were randomized to.
The groups that participants will be randomized to are:
Group 1: Standard PAI: 30 mg Toradol/ketorolac (30mg/ml), 49.25ml 0.5% ropivacaine (5mg/ml), and 0.5 mg epinephrine (1mg/ml), 0.8 ml clonidine (0.1mg/ml) and 8.45 ml 0.9% sodium chloride Group 2: Standard PAI + 40mg methylprednisolone (diabetics and pre-diabetics will not be randomized to this group) Group 3: Standard PAI + 32mg Zilretta (triamcinolone acetonide extended release injectable suspension)
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
- •Patients within the MHS who are DEERS eligible undergoing primary TKA at Walter Reed National Military Medical Center (WRNMMC), Surgery Center of Chevy Chase or District Surgery Center
- •Age 18 or older
- •successful surgical intervention
排除标准
- •Unicompartmental knee arthroplasty (UKA)
- •Revision total knee arthroplasty (rTKA)
- •Females who are pregnant or nursing
- •Allergic to ingredients in PAI or previous adverse reaction to steroids being used in this study
- •Diabetics will be excluded from Group 2 (standard PAI + methylprednisolone)
研究组 & 干预措施
Methylprednisolone
2. Group2 (n=40, non-diabetic): Standard PAI + 40mg methylprednisolone (n = 40)
干预措施: PAI + steroid (Drug)
Standard PAI
Group1 (n=80; 40 non-diabetic and 40 diabetic participants): Standard PAI: 30 mg Toradol/ketorolac (30mg/ml), 49.25ml 0.5% ropivacaine (5mg/ml), and 0.5 mg epinephrine (1mg/ml), 0.8 ml clonidine (0.1mg/ml) and 8.45 ml 0.9% sodium chloride
干预措施: PAI (Drug)
Zilretta
3. Group3 (n=80; 40 non-diabetic and 40 diabetic participants): Standard PAI + 32mg Zilretta (triamcinolone acetonide extended release injectable suspension)
干预措施: PAI + zilretta (Drug)
结局指标
主要结局
The primary outcome is to determine whether total knee arthroplasty outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone.
时间窗: 24 hours, 72 hours, 7 days, and 28 days post
The following outcomes after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: • Improvement in pain levels postoperatively based on measurement of pain intensity using a Visual Analogue Scale (VAS) at 24hrs, 72 hours, and 7 days (all phone call), and 28 days
Postoperative ROM
时间窗: 28, 120 and 365 days postop
The following outcomes after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: Change in range of motion (ROM) at 28, 120 and 365 days postop
Patient reported outcome measure
时间窗: 120 and 365 days postoperatively
The following outcomes after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: • Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) score at 120 and 365 days postoperatively
Patient reported outcome measures 2
时间窗: 120 and 365 days postop
The following outcomes after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: • Change in Single Assessment Numeric Evaluation (SANE) score at 120 and 365 days postop
Postop pain medication usage
时间窗: 24hrs, 72 hours, and 7 days, and 28 days postop
The following outcomes after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: • Decreased morphine equivalent (MEQ) postoperatively at 24hrs, 72 hours, and 7 days (all phone call), and 28 days
MUA rate
时间窗: 28 days postop
The following outcome after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: • Decreased manipulation under anesthesia rates (MUA) compared to historical rate at our institution at 28 days
次要结局
- Adverse events and subgroup analysis(28 days, 120 days, 365 days postop)
研究者
Ian P. Marshall
Resident Physician, Orthopaedic Surgery
Walter Reed National Military Medical Center