Knotless Suture in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Time of Closure in Minutes
研究概览
简要总结
Barbed suture has been demonstrated to be safe in primary hip and knee surgery and retrospective data suggests barbed suture represents no increased complications in the revision setting. Barbed suture may represent a faster, more effective way to perform revision arthroplasty closures. There are no Level I studies comparing traditional and barbed suture closure. The purpose of this study is to assess the surgical complexities of closures using closure time without sacrificing cosmesis or wound complications between the traditional closure and barbed closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 ≥ 18 years of age
- •Surgical candidates undergoing revision total knee or total hip arthroplasty for one of the following indications second stage of two stage reimplantation for infection, mechanical loosening, instability, polyethylene wear, stiffness, or periprosthetic fracture
排除标准
- •Patient is ≤ 18 years of age
- •Patient is unable to provide written consent
- •Patient has active infections in the operative leg/joint
- •Known Allergy to Suture material
- •Underlying Dermatological diseases affecting surgical site including dermatitis, eczema, or psoriasis; connective tissue or vascular disorders or diseases that would adversely affect wound healing; metastatic cancer; renal insufficiency (dialysis); steroid dependence; malnourishment; and other disease processes resulting in an immunocompromised state. Diabetes, smoking and obesity will be allowed as they are frequent comorbidities in our revision joint population
- •Anterior total hip replacement
- •Stage 1 of two stage revision for infection
- •Closure performed by plastic surgeon, including flap coverage
- •Vulnerable populations will not be enrolled in this study.
- •Withdrawal Criteria
- •Failure to attend regularly scheduled follow up appointments
- •Deviation from closure protocol
研究组 & 干预措施
Revision total knee arthroplasty: control
干预措施: Conventional Closure: Knee (Device)
Revision total knee arthroplasty: active
干预措施: Barbed suture closure: Knee (Device)
Revision Total Hip Arthroplasty: control
干预措施: Conventional Closure: Hip (Device)
Revision Total Hip Arthroplasty: active
干预措施: Barbed suture closure: Hip (Device)
结局指标
主要结局
Time of Closure in Minutes
时间窗: Up to a maximum of 66 minutes (perioperative)
Measurement of the time needed to properly close the wound with each technique.
次要结局
- Mean Length of Incision(30 minutes (perioperative))
- Mean Number of Sutures Used(45 minutes (perioperative))
- Incidence of Complications Related to Wound Closure(Day 90)
- Patient and Observer Scar Assessment Scale (POSAS) Score(Week 6 Post-Surgery)