A Multicenter, Randomized, Clinical Outcome of VISIONAIRE™ Patient Matched Technology vs. Standard Surgical Instrumentation in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 134
- 试验地点
- 14
- 主要终点
- Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score
研究概览
简要总结
The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched cutting blocks. Data will be collected at preoperative, operative/discharge, 3 months, 1 year and 2 years after TKA. The secondary objective of this study is to compare the safety, quality of life, and economic outcomes of TKA when these two techniques are utilized. This study does not involve treatment or investigational products, as all components are FDA cleared and are commercially available.
详细描述
This is a prospective study comparing VISIONAIRE™ to standard TKA instrumentation. The objective of this study is to evaluate the safety and efficacy of TKA using VISIONAIRE™ when compared with standard instrumentation, including device survival, improvement in function and implant alignment after TKA. This study will also document any device-related, surgical complications and/or adverse radiographic observations.
In contrast with the control group clinical outcomes following TKA completed with VISIONAIRE™ have yet to be assessed. The current investigation will determine if there is any difference in TKA outcomes when VISIONAIRE™ patient matched technology is utilized versus standard instrumentation. All patients meeting the inclusion/exclusion criteria specified in this protocol will be asked to participate in the study. If the patient consents to participate, they will be enrolled in the study and randomized to one of the two study arms. Patients requiring TKA will be implanted with Legion, Genesis II or Journey BCS (Smith & Nephew) total knee implant systems. Standard instrumentation will be used to assist the surgeon in placing the implant in the control group. In the VISIONAIRE™ group, standard instrumentation will not be used in the surgery. Patients randomized to the VISIONAIRE™ arm will have an MRI preoperatively that will be used to create the customized cutting blocks. All patients will have an x-ray at each postoperative interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the inclusion criteria.
- •Patient diagnosed with degenerative arthritis of the knee requiring a unilateral primary TKA.
- •Patient is of legal age to consent and is skeletally mature.
- •Patient is willing to sign and date an ethics-approved consent form.
- •Patient is willing to be available for two-year follow-up postoperatively
排除标准
- •Patients must not meet any of the exclusion criteria.
- •Patient is known to have poor bone stock making a TKA unjustifiable.
- •Patient is immuno-suppressed.
- •Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
- •Patient is pregnant or may become pregnant during the course of the study.
- •Patient has a history of prior ipsilateral major knee surgery (e.g. arthroplasty, high tibial osteotomy, or tibial plateau fracture). Minor prior procedures such as ACL repair, meniscectomy, or arthroscopy are not excluded.
- •Patient has active, localized or systemic infection.
- •Patient is severely overweight (BMI >40).
- •Patient is a prisoner.
- •Subject has a significant MRI (magnetic resonance imaging) exclusion or contraindication.
- •Patient has had a total joint arthroplasty of the contralateral limb in the last 12 months.
结局指标
主要结局
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score
时间窗: 2 years postoperatively
The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS Total Score (0-100 points) included a combined evaluation of joint motion (0-25 points), instability (0-25 points), alignment (0-25 points), and symptoms (0-25 points). A higher score indicated a better outcome for subjects.
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
时间窗: 2 years postoperatively
The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS clinical evaluation included a questionnaire completed by the investigators to assess for pain, stability, flexion contracture, extension lag, and alignment and evaluated based on number of subjects experiencing any of these issues at the 2-year postoperative visit.
次要结局
- Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray(3 months postoperative)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively(Baseline (preoperative), 3 months, 1 year, and 2 years postoperatively)
- Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively(2 years postoperatively)
- Evaluation of Health Economic Criteria - Blood Loss(During and immediately following surgery)
- Evaluation of Health Economic Criteria - Incision Length(During and immediately following surgery)
- Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively(2 years postoperatively)
- Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively(1 year postoperatively)
- Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively(1 year postoperatively)
- Evaluation of Health Economic Criteria - Surgical Time Details(During and immediately following surgery)
- Evaluation of Health Economic Criteria - Instrument Tray Use(During and immediately following surgery)
- Evaluation of Health Economic Surgical Criteria(During and immediately following surgery)