Comparative Clinical Outcomes and Function Study Between MAKO Robotic-Arm Assisted UKA in ACL Intact and Deficient Knees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Functional and Clinical Outcomes comparing patients with and without intact Anterior Cruciate Ligaments undergoing arthroplasty with MAKO Robotic-Arm Assisted Surgery.
研究概览
简要总结
This study represents a single-surgeon/institution, non-randomized, consecutive series, prospective and comparative cohort design. The Principal Investigator is anticipating 100 study patients in the INTACT group and 35 patients in the Anterior Cruciate Ligament-Deficient group.The schedule of events lists the imaging procedures and questionnaires to be completed at each visit.
Subjects will be consented and enrolled within 28 days prior to surgery and participate in follow-up visits for two years following their Unicompartmental Knee Arthroplasty. A 3-year enrollment duration is anticipated to enroll a minimum and consecutive series of 25 patients in the experimental Anterior Cruciate Ligament-deficient group. Over the same enrollment duration, 100+ patients with intact Anterior Cruciate Ligaments are expected to be in the control group and undergo Unicompartmental Knee Arthroplasty. The enrollment duration (3 years) and total study duration (5 years) are based on patient volume estimates provided by the Principal Investigator.
详细描述
To compare functional and clinical outcomes in patients with and without intact Anterior Cruciate Ligament undergoing uni-compartmental knee arthroplasty with MAKOplasty Robotic-Arm Assisted Surgery. The primary outcome measurement tools utilized will be the Knee Society Score (KSS) and Knee Injury and Osteoarthritis Outcomes Score (KOOS,JR). Both the Knee Society Score and Knee Injury and Osteoarthritis Outcomes Score (KOOS,JR) are validated scoring systems. Patient-reported outcome data will be collected at the following study time points:
- Preoperatively - Knee Society Score: Pre-Op, Knee Injury and Osteoarthritis Outcomes Score
- 3 weeks (±1 week) - Knee Society Score: Post-Operative, Knee Injury and Osteoarthritis Outcomes Score , Subject Global Satisfaction Survey
- 6 weeks (± 1 week) - Knee Society Score: Post-Operative, Knee Injury and Osteoarthritis Outcomes Score, Subject Global Satisfaction Survey
- 3 months (± 2 weeks) - Knee Society Score: Post-Operative, Knee Injury and Osteoarthritis Outcomes Score, Subject Global Satisfaction Survey
- 1 year (± 1 month) - Knee Society Score: Post-Operative, Knee Injury and Osteoarthritis Outcomes Score, Subject Global Satisfaction Survey
- 2 years (± 2 months) - Knee Society Score: Post-Operative, Knee Injury and Osteoarthritis Outcomes Score, Subject Global Satisfaction Survey
Subject Identification
Each subject will be assigned a unique subject number. Subject numbers will not be re-assigned or re-used for any reason. Only assigned subject numbers and associated subject age, Anterior Cruciate Ligament integrity classification, pre/intra-operative imagery information, and temporal outcome data will be shared with Sponsor. Only subjects who meet the inclusion/exclusion criteria and sign the Inform Consent Form will be assigned a unique study identification number.
Pre-Operative Anterior Cruciate Ligament Integrity
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet these criteria to participate in this study:
- •Patients with isolated, symptomatic femorotibial knee arthritis and candidates for UKA;
- •Patients ≥ 21 years old;
- •Patients with intact and non-functional ACLs as determined through pre-operative imaging, knee laxity tests, rotational stability tests, and intraoperative ACL classification;
- •Patients willing and able to sign an informed consent;
- •Patients willing and able to comply with 2-year follow-up commitments.
排除标准
- •Any subject who meets any of the exclusion criteria will be excluded from participation in this study:
- •Patients with RA;
- •Patients with BMI >40;
- •Patients with ROM arc > 75°;
- •Patients with greater than 10º of hyperextension;
- •Patients with greater than 15º of varus or valgus deformity;
- •Patients with active infection;
- •Patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis;
- •Patients without sufficient soft tissue integrity to provide adequate stability;
- •Patients with either mental or neuromuscular disorders that do not allow control of the knee joint;
- •Patients whose weight, age or activity level might cause extreme loads and early failure of the system.
结局指标
主要结局
Functional and Clinical Outcomes comparing patients with and without intact Anterior Cruciate Ligaments undergoing arthroplasty with MAKO Robotic-Arm Assisted Surgery.
时间窗: Baseline (screening), compared to a 24 month follow-up visit. There are also several additional time points from 3 weeks, 6 weeks, 3 months, 6 months and 12 months where the functional and clinical outcomes are assessed.
Knee Society Score (KSS) and Knee Injury and Osteoarthritis Outcome Score (KOOS)
次要结局
- Global Satisfaction Survey(Baseline (screening), 3 weeks, 6 weeks, 3 months, 12 months, 24 months)
- Computed Tomography(Baseline (screening))
- Radiographs (3 views)(Baseline (screening))
- Height and Weight(Baseline (screening))
- Magnetic Resonance Imaging(Baseline (screening))
- Intra-Operative ACL Integrity(Enrollment (procedure day))