Comparing Knee Replacement Approaches with a Smart Implant

This study is comparing two different surgical approaches for total knee replacement (Total Knee Arthroplasty): the Medial Parapatellar Approach and the Subvastus Approach. Both approaches involve surgery to replace your knee joint. Researchers want to see which approach leads to a better and faster recovery. They will use a special smart implant called Zimmer Persona IQ to track your activity, like how many steps you take each day, after surgery. To join, you must be over 18, planning to have a primary total knee replacement, be eligible for both surgical approaches, and have an iPhone you're willing to use for two weeks before surgery to track your steps. The main goal is to see if there's a difference in daily step count between the two groups. The study's current status is unclear.

Study design
This is a randomized study comparing two surgical approaches for total knee replacement, with 110 planned participants. Participants will be randomly assigned to one of the two surgical groups.
What's involved
You would need to use your iPhone to track your steps for two weeks before surgery. After surgery, the smart implant will continuously track your recovery, and you will have follow-up appointments.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, with a minimum of 6 months of follow-up after surgery.

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NCT07348835

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

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Total Joint Specialists
~110 participants
Updated 2026-01-16 on ClinicalTrials.gov
What's tested:Total Knee Arthroplasty Medial Parapatellar ApproachTotal Knee Arthroplasty Subvastus Approach

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Step Count (steps/day)
Measured over Through study completion, minimum 6 months
+1 more outcome measured
Total Knee Anthroplasty
1 sites across 1 states
Georgia1

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Eligibility criteria

Inclusion

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

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
  • Step Count (steps/day)Through study completion, minimum 6 months

    Continuously recorded from PIQ device after it is implanted during surgery

  • Step Count (steps/day)Baseline

    Recorded from patients iPhone Health App for 2 weeks preoperatively