Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment on Patient Reported Outcome Measures (PROMs): A Prospective, Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Knee Society Score (KSS)
研究概览
简要总结
The purpose of this study is to evaluate both clinical measures and PROMs in patients undergoing total knee arthroplasty (TKA) using restricted inverse kinematic alignment (iKA) compared to mechanical alignment (MA), both using surgical navigation assistance.
详细描述
A prospective randomized clinical study will be conducted.
The study will consist of two cohorts and will collect clinical data from a maximum of 148 knee arthroplasty surgeries during which the patient will receive the Optetrak Logic® CR TKA device. Cohorts will consist of 1) subjects undergoing MA TKA and 2) subjects undergoing restricted iKA TKA. All cohorts will utilize navigation-assisted surgery (ExactechGPS®) and will be enrolled and consented concurrently. Subjects will be randomized and have a 50% chance of being assigned to the MA TKA cohort and a 50% chance of being assigned to the restricted iKA TKA cohort. Study and research staff will be blinded to randomization and the cohort allocation until after consenting and eligibility is determined. Subjects will be blinded to the randomization (MA TKA or restricted iKA TKA) until the completion of the study.
Data collection under this protocol shall be conducted in a way that conforms to any applicable local and national rules, regulations, and guidelines relating to the conduct of clinical research and the protection of human subjects. As appropriate, this may include but is not limited to the following: Good Clinical Practice (GCP) requirements, FDA regulations and guidelines, ISO 14155: 2020, ICH guidelines, HIPAA and other regulations pertaining to the protection of patient data and data privacy, guidelines established by local Institutional Review Boards or similar Ethics Committees, the Belmont Report, and the Declaration of Helsinki.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Study and research staff will be blinded to randomization and the cohort allocation until after consenting and eligibility is determined. Subjects will be blinded to the randomization (MA TKA or restricted iKA TKA) until the completion of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet all of the following inclusion criteria to be included in the study:
- •Subject must be at least 18 years of age at the time of the surgery (skeletally mature)
- •Subject will receive a Optetrak Logic® CR device per the "Indications for Use" described above
- •Subject must be willing to comply with the pre-operative and post-operative visit requirements
- •Subject must be willing and able to provide written informed consent for participation in the study
排除标准
- •Subjects will be excluded from the study if they meet any of the following exclusion criteria:
- •Subject with a suspected or confirmed systemic infection and/or a secondary remote infection
- •Subject without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis
- •Subject without sufficient soft tissue integrity to provide adequate stability
- •Subject with either mental or neuromuscular disorders that do not allow control of the knee joint
- •Subjects whose weight, age, or activity level might cause extreme loads and early failure of the system
- •Subject is participating in another drug or device study other than knee replacement within the last three (3) months
- •Subject has behavioral and/or mental issues that may interfere with their ability to follow post-operative instructions
- •Subject is a prisoner
- •Subject is pregnant
- •Subject is undergoing radiation therapy where the targeted field involves the knee joint
- •Subjects with malignancy involving proximal tibia, distal femur, or knee joint
- •Subjects undergoing active administration of chemotherapy
结局指标
主要结局
Knee Society Score (KSS)
时间窗: 12-month
Validated outcome score
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 12-month
Validated outcome score
Forgotten Joint Score (FJS)
时间窗: 12-month
Validated outcome score
Visual Analog Scale (VAS) - Patient Satisfaction
时间窗: 12-month
Visual scale from 1-10 (high score is better)
Visual Analog Scale (VAS) - Pain
时间窗: 12-month
Visual scale from 1-10 (low score is better)
次要结局
- Knee Alignment(Intraoperative)