NCT07348835

Using a Smart Implantable Device to Compare Early Recovery in Two Different Knee Arthroplasty Approaches

Continuous Monitoring Using a Smart Implantable Device (Persona IQ®) to Compare Medial Parapatellar vs. Subvastus Approaches in Early Post-Operative Total Knee Arthroplasty Recovery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Total Joint Specialists · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Total Knee Anthroplasty

Interventions

Type	Name	Description
PROCEDURE	Total Knee Arthroplasty Medial Parapatellar Approach	Incision splitting quad
PROCEDURE	Total Knee Arthroplasty Subvastus Approach	quad-sparing approach

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: United States