Using a Smart Implantable Device to Compare Early Recovery in Two Different Knee Arthroplasty App… (NCT07348835) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Using a Smart Implantable Device to Compare Early Recovery in Two Different Knee Arthroplasty Approaches
United States110 participantsStarted 2026-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Step Count (steps/day)
Timeframe: Through study completion, minimum 6 months