Surgical Approaches for Total Knee Replacement
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for individuals undergoing total knee replacement who will receive a Zimmer Persona IQ smart implant. Participants should be able to use an iPhone preoperatively and commit to follow-up for at least 6 months post-surgery. Specific eligibility criteria are not provided, but typically include adults in need of the surgery with no major health issues that would interfere with recovery or data collection.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Total Knee Arthroplasty Medial Parapatellar Approach
- Total Knee Arthroplasty Subvastus Approach
Trial Overview
The study compares two surgical techniques for knee replacement: medial parapatellar and subvastus approaches. It uses a smart implantable device to monitor patients' gait and activity levels before and after surgery, aiming to assess which approach leads to better early recovery based on step count, range of motion, walking speed, stride length, distance walked, pain levels, and patient-reported outcomes.
How Is the Trial Designed?
2
Treatment groups
Active Control
Primary total knee arthroplasty performed using the subvastus surgical approach
Primary total knee arthroplasty performed using the medial parapatellar surgical approach
Find a Clinic Near You
Who Is Running the Clinical Trial?
Total Joint Specialists
Lead Sponsor
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