Continuous Monitoring Using a Smart Implantable Device (Persona IQ®) to Compare Medial Parapatellar vs. Subvastus Approaches in Early Post-Operative Total Knee Arthroplasty Recovery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Step Count (steps/day)
研究概览
简要总结
This is a single-institution, prospective, randomized study comparing the medial parapatellar and subvastus approaches in primary total knee arthroplasty using continuous, implant-based gait monitoring. Patients receiving a Zimmer Persona IQ smart implant will be followed preoperatively and through the first 30 days post-operatively, with extended follow-up to 6 months. Preoperative activity is captured using iPhone Health step-count data, while post-operative recovery is assessed using continuous tibial implant data, including step count, range of motion, cadence, walking speed, stride length, and distance. These objective metrics are correlated with PROMs. The primary outcome is daily step count. Secondary outcomes include early functional milestones, pain, and patient-reported functional scores. This study is designed to characterize early recovery trajectories and determine whether meaningful differences exist between surgical approaches.
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
- Single (Participant)
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
- •All patients older than 18 years of age who plan to undergo medial congruent polyethylene bearing primary TKA with a PIQ
- •Eligible for both approaches
- •Have an iPhone and willing to "wear" it for two weeks preoperatively to get an estimated average stepcount
- •Provide informed consent
- •Willing to complete follow ups
排除标准
- •Patients with TKA revisions
- •Patients with insufficient pre-operative range of motion in the operative knee (flexion contracture of > 20 degrees or < 90° of knee flexion)
- •Patients with Contralateral TKA within study time frame
- •Patients with TKA other than medial congruent polyethylene bearing
- •Patients with bilateral surgery
- •Patients without a valid and active email address
- •Patients not willing or able to participate in study and follow-ups
- •Patients who use assisted devices to ambulate
- •Rheumatoid arthritis
研究组 & 干预措施
Medial Parapatellar Approach
Primary total knee arthroplasty performed using the medial parapatellar surgical approach
干预措施: Total Knee Arthroplasty Medial Parapatellar Approach (Procedure)
Subvastus Approach
Primary total knee arthroplasty performed using the subvastus surgical approach
干预措施: Total Knee Arthroplasty Subvastus Approach (Procedure)
结局指标
主要结局
Step Count (steps/day)
时间窗: Through study completion, minimum 6 months
Continuously recorded from PIQ device after it is implanted during surgery
Step Count (steps/day)
时间窗: Baseline
Recorded from patients iPhone Health App for 2 weeks preoperatively
次要结局
- Stride Length (m)(Through study completion, minimum 6 months)
- Distance Travelled (km)(Through study completion, minimum 6 months)
- Functional Range of Motion (degrees)(Through study completion, minimum 6 months)
- Tibial Range of Motion (degrees)(Through study completion, minimum 6 months)
- Cadence (steps/minute)(Through study completion, minimum 6 months)
- Walking Speed (m/s)(Through study completion, minimum 6 months)
- Goniometric Functional Range of Motion(Preoperatively and at 6 weeks)
- Surgical Side(Preoperatively)
- Age(Preoperatively)
- Sex(Preoperatively)
- Weight(Preoperatively)
- Height(Preoperatively)
- Body Mass Index (BMI)(Preoperatively)
- Comorbidities(Preoperatively)
- Charlson Comorbidity Index (CCI)(Preoperatively)
- Time to Achieving Key Milestones in Daily Activities(6 weeks postoperatively)
- Veterans Rand 12-Item (VR-12) Health Survey(Preoperatively, 6 weeks postoperatively, 6 months postoperatively)
- Procedure Satisfaction(6 weeks postoperatively)
- Numeric Pain Rating Scale (NPRS)(Preoperatively, 6 weeks postoperatively)
- Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)(Preoperatively, 6 weeks postoperatively, 6 months postoperatively)
- Forgotten Joint Score (FJS)(Preoperatively, 6 weeks postoperatively, 6 months postoperatively)