Dissection Technique of Medial Subperiosteal Release on the Incidence of Pes Bursitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in Visual Analogue Pain Scale (VAS)
研究概览
简要总结
Medial subperiosteal release is a commonly performed technique to improve surgical exposure and aid in joint balancing. This is a routine step during primary total knee arthroplasty that will be conducted on every enrolled patient. This is commonly performed both via scalpel (aka sharp medial peel) or electrocautery. The intervention will be randomly assigning subjects undergoing TKA into two groups, one receiving subperiosteal release using a scalpel (aka sharp medial peel) and the other via electrocautery.
详细描述
Medial release is a commonly performed technique to improve surgical exposure and aid in joint balancing. It is thought to be linked to the postoperative incidence of pes bursitis. However, the effect of scalpel vs electrocautery techniques for subperiosteal release has not been examined for their potential effect on the rates of pes bursitis. This randomized clinical trial will assign patients undergoing TKA for osteoarthritis (OA) into either scalpel or electrocautery release groups for their operation and will be followed postoperatively at 3 weeks and 3,6, and 12 months in order to determine the effect of release technique on rates of pes bursitis. This study will take place at Emory Orthopaedics. Subjects will not be compensated. Patients presenting to the clinic for evaluation of TKA will be screened for their eligibility in this study and recruited as well as consented in the clinic. This study can advance current clinical knowledge by evaluating two common surgical techniques to determine which may lead to better outcomes for patients undergoing TKA, a common orthopedic procedure, and reduce dissatisfaction as well as pain following operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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 over age 18
- •Patients undergoing primary TKA for osteoarthritis
排除标准
- •Patients undergoing revision TKA
- •Any patients not undergoing TKA for non-OA diagnosis
- •Adults unable to consent
- •Pregnant women
- •Prisoners
结局指标
主要结局
Change in Visual Analogue Pain Scale (VAS)
时间窗: Before and after surgery at the 3 month, 6 month, and 12 month follow-ups
The visual analog scale (VAS) is a tool used to measure pain. Patients will be asked to indicate their perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge .
Change in Incidence of Pes bursitis
时间窗: 3 weeks, 3 months, 6 months, and 12 months post-operatively.
All patients will be seen post-operatively to monitor their progress and minimize risks, and the diagnosis of pes bursitis will be determined through clinical exam.
Change in Oxford Knee Score (OKS)
时间窗: Before and after surgery at the 3 month, 6 month, and 12 month follow-ups
The Oxford Knee Score (OKS) is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty)
次要结局
- Changes in Varus valgus knee assessment(3 weeks, 3 months, 6 months, and 12 months post-operatively.)
研究者
Ajay Premkumar
Assistant Professor
Emory University