Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty? A Randomized Controlled Noninferiority Trial
This study is a prospective, randomized, controlled, noninferiority trial with parallel assignment that will afford simultaneous assessment of the omission of dental clearance and the omission of post-operative antibiotics for dental procedures.
研究概览
详细说明
A noninferiority design is chosen because elimination of a preoperative requirement may offer substantial benefits in cost, access, and timeliness of care; provided infection risk is not meaningfully increased.
Study Questions
- Is omission of routine preoperative dental clearance non-inferior to mandatory dental clearance with respect to prosthetic joint infection risk following elective primary hip or knee arthroplasty?
- Is omission of routine postoperative antibiotic prophylaxis non-inferior to prescription of routine antibiotic prophylaxis with respect to prosthetic joint infection risk following elective primary hip or knee arthroplasty?
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：John Green, MD
- 电话号码：402-717-0820
- 邮箱：JohnGreen1@creighton.edu
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
- Age ≥19 years (19 is age of majority in Nebraska)
- Scheduled for elective primary THA or TKA (i.e. no revision or conversion procedures)
- Ability to provide informed consent
Exclusion Criteria
- Revision arthroplasty
- Arthroplasty for fracture or performed urgently (i.e. incomplete work up)
- Active or previous infection of the operative joint
- Active systemic infection
- On chronic antibiotic therapy
All patients who meet the above criteria will be offered inclusion in the study either at their pre-operative clinic visit or over the phone.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：1. Obtains dental clearance and undergoes routine antibiotic prophylaxis
|
|
|
实验性的：2. Omits dental clearance and undergoes routine antibiotic prophylaxis
|
Dental Clearance Group Participants will undergo standardized preoperative dental evaluation. Any dental treatment recommended by the treating dental provider must be completed prior to surgery, with written clearance documented before proceeding. No Dental Clearance Group Participants will proceed directly to arthroplasty without mandatory dental evaluation. Acute dental symptoms arising preoperatively will be managed according to standard clinical practice. Routine Antibiotic Prophylaxis Group Participants will receive antibiotic prophylaxis before every dental procedure, including routine cleanings:
No Antibiotic Prophylaxis Group Participants will receive no routine antibiotic prophylaxis prior to any dental procedure, including cleanings. All other dental care will proceed per standard practice. |
|
实验性的：3. Obtains dental clearance and omits routine antibiotic prophylaxis
|
Dental Clearance Group Participants will undergo standardized preoperative dental evaluation. Any dental treatment recommended by the treating dental provider must be completed prior to surgery, with written clearance documented before proceeding. No Dental Clearance Group Participants will proceed directly to arthroplasty without mandatory dental evaluation. Acute dental symptoms arising preoperatively will be managed according to standard clinical practice. Routine Antibiotic Prophylaxis Group Participants will receive antibiotic prophylaxis before every dental procedure, including routine cleanings:
No Antibiotic Prophylaxis Group Participants will receive no routine antibiotic prophylaxis prior to any dental procedure, including cleanings. All other dental care will proceed per standard practice. |
|
实验性的：4. Omits dental clearance and routine antibiotic prophylaxis
|
Dental Clearance Group Participants will undergo standardized preoperative dental evaluation. Any dental treatment recommended by the treating dental provider must be completed prior to surgery, with written clearance documented before proceeding. No Dental Clearance Group Participants will proceed directly to arthroplasty without mandatory dental evaluation. Acute dental symptoms arising preoperatively will be managed according to standard clinical practice. Routine Antibiotic Prophylaxis Group Participants will receive antibiotic prophylaxis before every dental procedure, including routine cleanings:
No Antibiotic Prophylaxis Group Participants will receive no routine antibiotic prophylaxis prior to any dental procedure, including cleanings. All other dental care will proceed per standard practice. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Periprosthetic joint infection (PJI) within 12 months, defined using Musculoskeletal Infection Society criteria (Parvizi, et al).
大体时间：12 Months
|
1. To determine whether omission of routine preoperative dental clearance is non-inferior to mandatory dental clearance in preventing periprosthetic joint infection within 12 months following primary TJA. |
12 Months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
• Periprosthetic joint infection at 24, 36, 48, 60 and 120 months, defined using Musculoskeletal Infection Society criteria (Parvizi, et al).
大体时间：120 months
|
5. To determine whether the omission of dental clearance or omission of routine dental clearance is non-inferior to routine use of these perioperatively at longer term follow up (2, 5 and 10 years). |
120 months
|
|
• Time from scheduling to surgery (i.e. delay caused by dental clearance)
大体时间：3-5 years
|
1. To compare time from surgical scheduling to operative date. |
3-5 years
|
|
• Rate of patients requiring dental procedure before getting dental clearance
大体时间：3-5 years
|
2. To determine the rate of dental intervention in patients requiring clearance. |
3-5 years
|
|
• Number of reoperations and which procedure is performed for PJI.
大体时间：3-5 years
|
3. To compare reoperation and revision arthroplasty rates for infection. |
3-5 years
|
|
• Causative organisms of PJI
大体时间：3-5 years
|
4. To characterize microbiologic profiles of PJIs. |
3-5 years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- CommonSpirit IRB 2447281-1
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Results will otherwise be disseminated through academic journals as well as poster or podium presentations at academic meetings.
IPD 共享支持信息类型
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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