A Prospective Randomized Controlled Trial Comparing Constrained Condylar vs Posterior Stabilized Articulations in Revision Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Clinical patient reported outcomes
研究概览
简要总结
This study aims to compare the clinical impact of Constrained Condylar versus Posterior Stabilized Knee (PS) bearings on patient satisfaction and surgical outcomes including mid-term survivorship among patients undergoing revision total knee arthroplasty.
详细描述
The primary purpose of this study is to determine whether a difference exists in clinical patient reported outcomes between CCK or PS bearings following rTKA. A secondary goal of the study is to compare both bearings in survivorship free of revision surgery as well as other surgical complications including instability, in early to mid-term follow-up.
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
- None
盲法说明
only the patient is blinded ahead of time
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 between 18-80 years of age
- •Patients who are undergoing both femoral and tibial component revisions, or isolated femoral component revisions with a retained tibial component that is compatible with PS or CCK bearings
- •Patients who are at least 6-weeks out from primary TKA surgery, with complete pre-operative and post-operative knee radiographs obtained at standard of care perioperative visits (AP/lateral and patellar views)
- •Patients undergoing rTKA for indications including aseptic component loosening, flexion or extension coronal or sagittal instability, component malalignment, arthrofibrosis, patellar maltracking, reimplantation following single or two-stage exchange revision for prosthetic joint infection or bearing surface wear when femoral or tibial component revision is indicated.
- •The use of revision total knee arthroplasty systems which have PS and CCK bearing options including different degree options of coronal and rotational constraint (to be individually randomized per constrained option):
- •Zimmer Biomet Persona, NexGen, or Vanguard
- •Smith and Nephew Legion
- •DJO / Enovis Empowr
- •Stryker Triathlon
- •Link SymphoKnee
- •Depuy Attune sion Criteria:
排除标准
- •Patients undergoing rTKA with a hinged implant, or pre-operatively determined to require CCK bearing rTKA, > 80 years of age, or those requiring rTKA less than 6-weeks from the primary TKA,
- •Patients undergoing rTKA for bearing exchange only rTKA, isolated tibial component rTKA
- •Patients with pre-operative diagnosis of extensor mechanism disruption or collateral ligament incompetence or with a compromised soft tissue envelope requiring pre-pre-operative plastic surgery evaluation and planned soft tissue coverage.
结局指标
主要结局
Clinical patient reported outcomes
时间窗: 20 year post op
Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)
次要结局
- Clinical reported outcomes (Koos Jr)(6 weeks to 20 years post op)
- Range of motion over time(pre op to 20 years pots op)
- Clinical reported outcomes ( VR-12)(6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op)
- Clinical reported outcomes ( Forgotten Joint Score)(6 weeks to 20 years post op)
- Clinical reported outcomes (EQ-5D-3L)(6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op)
研究者
Omar Behery
Principle Investigator
Rush University Medical Center