About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Total Knee Arthroplasty Medial Parapatellar Approach
Procedure/SurgeryIncision splitting quad
Total Knee Arthroplasty Subvastus Approach
Procedure/Surgeryquad-sparing approach
Treatment groups
Trial outcomes
Primary outcomes
Step Count (steps/day)
Continuously recorded from PIQ device after it is implanted during surgery
Step Count (steps/day)
Recorded from patients iPhone Health App for 2 weeks preoperatively
Secondary outcomes
Stride Length (m)
Continuously recorded from PIQ device after it is implanted during surgery
Distance Travelled (km)
Continuously recorded from PIQ device after it is implanted during surgery
Functional Range of Motion (degrees)
Continuously recorded from PIQ device after it is implanted during surgery
Tibial Range of Motion (degrees)
Continuously recorded from PIQ device after it is implanted during surgery
Sponsors and contacts
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