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NCT Number: NCT07348835

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

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.

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Key information

Conditions

Total Knee Anthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Total Joint Surgery Center Atlanta

Sandy Springs, Georgia, 30328, United States

Location contact

Charlotte C Baker, B.S.

SUB_INVESTIGATOR

Thomas L Bradbury, M.D.

PRINCIPAL_INVESTIGATOR

Zachary M Ricciardelli, B.S.

CONTACT

[email protected]

(615)-957-0334

Zachary M Ricciardelli, B.S.

SUB_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Knee Arthroplasty Medial Parapatellar Approach

Procedure

Incision splitting quad

Total Knee Arthroplasty Subvastus Approach

Procedure

quad-sparing approach

Primary outcomes

  1. Step Count (steps/day)

    Time frame: Through study completion, minimum 6 months

    Continuously recorded from PIQ device after it is implanted during surgery

  2. Step Count (steps/day)

    Time frame: Baseline

    Recorded from patients iPhone Health App for 2 weeks preoperatively

Secondary outcomes

  1. Stride Length (m)

    Time frame: Through study completion, minimum 6 months

    Continuously recorded from PIQ device after it is implanted during surgery

  2. Distance Travelled (km)

    Time frame: Through study completion, minimum 6 months

    Continuously recorded from PIQ device after it is implanted during surgery

  3. Functional Range of Motion (degrees)

    Time frame: Through study completion, minimum 6 months

    Continuously recorded from PIQ device after it is implanted during surgery

  4. Tibial Range of Motion (degrees)

    Time frame: Through study completion, minimum 6 months

    Continuously recorded from PIQ device after it is implanted during surgery

  5. Cadence (steps/minute)

    Time frame: Through study completion, minimum 6 months

    Continuously recorded from PIQ device after it is implanted during surgery

  6. Walking Speed (m/s)

    Time frame: Through study completion, minimum 6 months

    Continuously recorded from PIQ device after it is implanted during surgery

  7. Goniometric Functional Range of Motion

    Time frame: Preoperatively and at 6 weeks

    Measured in degrees using a goniometer

  8. Surgical Side

    Time frame: Preoperatively

    Left or Right

  9. Age

    Time frame: Preoperatively

    In years, from EMR

  10. Sex

    Time frame: Preoperatively

    Male or Female, from EMR

  11. Weight

    Time frame: Preoperatively

    In kg, from EMR

  12. Height

    Time frame: Preoperatively

    In cm, from EMR

  13. Body Mass Index (BMI)

    Time frame: Preoperatively

    in kg/m2, from EMR

  14. Comorbidities

    Time frame: Preoperatively

    Collected and listed from EMR

  15. Charlson Comorbidity Index (CCI)

    Time frame: Preoperatively

    Calculated from formula using comorbidities collected from EMR

  16. Time to Achieving Key Milestones in Daily Activities

    Time frame: 6 weeks postoperatively

    Survey score collected (less time = better), Survey via Force Therapeutics

  17. 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

  18. Procedure Satisfaction

    Time frame: 6 weeks postoperatively

    Survey score collected (0-5; 5 best), Survey via Force Therapeutics

  19. Numeric Pain Rating Scale (NPRS)

    Time frame: Preoperatively, 6 weeks postoperatively

    Survey score collected (0-10; 0 best), Survey via Force Therapeutics

  20. 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

  21. Forgotten Joint Score (FJS)

    Time frame: Preoperatively, 6 weeks postoperatively, 6 months postoperatively

    Survey score collected (0-100; 100 best), Survey via Force Therapeutics

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas L Bradbury, M.D.

CONTACT

[email protected]

(404)-759-3912

Sponsors and collaborators

Lead sponsor

Total Joint Specialists

Network

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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