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

January 9, 2026 updated by: Total Joint Specialists

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Total Joint Surgery Center Atlanta
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas L Bradbury, M.D.
        • Sub-Investigator:
          • Zachary M Ricciardelli, B.S.
        • Sub-Investigator:
          • Charlotte C Baker, B.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Medial Parapatellar Approach
Primary total knee arthroplasty performed using the medial parapatellar surgical approach
Procedure: Total Knee Arthroplasty Medial Parapatellar Approach
Incision splitting quad
Active Comparator: Subvastus Approach
Primary total knee arthroplasty performed using the subvastus surgical approach
Procedure: Total Knee Arthroplasty Subvastus Approach
quad-sparing approach

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Step Count (steps/day)
Time Frame: Through study completion, minimum 6 months
Continuously recorded from PIQ device after it is implanted during surgery
Through study completion, minimum 6 months
Step Count (steps/day)
Time Frame: Baseline
Recorded from patients iPhone Health App for 2 weeks preoperatively
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stride Length (m)
Time Frame: Through study completion, minimum 6 months
Continuously recorded from PIQ device after it is implanted during surgery
Through study completion, minimum 6 months
Distance Travelled (km)
Time Frame: Through study completion, minimum 6 months
Continuously recorded from PIQ device after it is implanted during surgery
Through study completion, minimum 6 months
Functional Range of Motion (degrees)
Time Frame: Through study completion, minimum 6 months
Continuously recorded from PIQ device after it is implanted during surgery
Through study completion, minimum 6 months
Tibial Range of Motion (degrees)
Time Frame: Through study completion, minimum 6 months
Continuously recorded from PIQ device after it is implanted during surgery
Through study completion, minimum 6 months
Cadence (steps/minute)
Time Frame: Through study completion, minimum 6 months
Continuously recorded from PIQ device after it is implanted during surgery
Through study completion, minimum 6 months
Walking Speed (m/s)
Time Frame: Through study completion, minimum 6 months
Continuously recorded from PIQ device after it is implanted during surgery
Through study completion, minimum 6 months
Goniometric Functional Range of Motion
Time Frame: Preoperatively and at 6 weeks
Measured in degrees using a goniometer
Preoperatively and at 6 weeks
Surgical Side
Time Frame: Preoperatively
Left or Right
Preoperatively
Age
Time Frame: Preoperatively
In years, from EMR
Preoperatively
Sex
Time Frame: Preoperatively
Male or Female, from EMR
Preoperatively
Weight
Time Frame: Preoperatively
In kg, from EMR
Preoperatively
Height
Time Frame: Preoperatively
In cm, from EMR
Preoperatively
Body Mass Index (BMI)
Time Frame: Preoperatively
in kg/m2, from EMR
Preoperatively
Comorbidities
Time Frame: Preoperatively
Collected and listed from EMR
Preoperatively
Charlson Comorbidity Index (CCI)
Time Frame: Preoperatively
Calculated from formula using comorbidities collected from EMR
Preoperatively
Time to Achieving Key Milestones in Daily Activities
Time Frame: 6 weeks postoperatively
Survey score collected (less time = better), Survey via Force Therapeutics
6 weeks postoperatively
Veterans Rand 12-Item (VR-12) Health Survey
Time Frame: Preoperatively, 6 weeks postoperatively, 6 months postoperatively
Mental and Physical component survey scores collected (0-100); Survey via Force Therapeutics
Preoperatively, 6 weeks postoperatively, 6 months postoperatively
Procedure Satisfaction
Time Frame: 6 weeks postoperatively
Survey score collected (0-5; 5 best), Survey via Force Therapeutics
6 weeks postoperatively
Numeric Pain Rating Scale (NPRS)
Time Frame: Preoperatively, 6 weeks postoperatively
Survey score collected (0-10; 0 best), Survey via Force Therapeutics
Preoperatively, 6 weeks postoperatively
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)
Time Frame: Preoperatively, 6 weeks postoperatively, 6 months postoperatively
Survey score collected (0-100; 100 best), Survey via Force Therapeutics
Preoperatively, 6 weeks postoperatively, 6 months postoperatively
Forgotten Joint Score (FJS)
Time Frame: Preoperatively, 6 weeks postoperatively, 6 months postoperatively
Survey score collected (0-100; 100 best), Survey via Force Therapeutics
Preoperatively, 6 weeks postoperatively, 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Total Joint Specialists

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2026

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NSH1432

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will only be used as necessary by the authorized research team and always secured, it will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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