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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTotal Joint Specialists

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Total Knee Arthroplasty Medial Parapatellar Approach

    Procedure/Surgery

    Incision splitting quad

  • Total Knee Arthroplasty Subvastus Approach

    Procedure/Surgery

    quad-sparing approach

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Medial Parapatellar ApproachActive comparator 1 intervention
Group B: Subvastus ApproachActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Step Count (steps/day)

Continuously recorded from PIQ device after it is implanted during surgery

Time frame
Through study completion, minimum 6 months
2

Step Count (steps/day)

Recorded from patients iPhone Health App for 2 weeks preoperatively

Time frame
Baseline

Secondary outcomes

1

Stride Length (m)

Continuously recorded from PIQ device after it is implanted during surgery

Time frame
Through study completion, minimum 6 months
2

Distance Travelled (km)

Continuously recorded from PIQ device after it is implanted during surgery

Time frame
Through study completion, minimum 6 months
3

Functional Range of Motion (degrees)

Continuously recorded from PIQ device after it is implanted during surgery

Time frame
Through study completion, minimum 6 months
4

Tibial Range of Motion (degrees)

Continuously recorded from PIQ device after it is implanted during surgery

Time frame
Through study completion, minimum 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: