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Not yet recruitingNCT07348835Updated Jan 16, 2026

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

An interventional study of Total Knee Arthroplasty Medial Parapatellar Approach and Total Knee Arthroplasty Subvastus Approach in Total Knee Anthroplasty, sponsored by Total Joint Specialists. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by Total Joint Specialists · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Total Knee Anthroplasty

Keywords

  • Total Knee Arthroplasty
  • Medial Parapatellar Approach
  • Subvastus Approach
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In context

Lead sponsor

Total Joint Specialists is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
110 participants (estimated)

Study arms

  • Active comparator
    Medial Parapatellar Approach

    Primary total knee arthroplasty performed using the medial parapatellar surgical approach

    Procedure: Total Knee Arthroplasty Medial Parapatellar Approach

  • Active comparator
    Subvastus Approach

    Primary total knee arthroplasty performed using the subvastus surgical approach

    Procedure: Total Knee Arthroplasty Subvastus Approach

Interventions

  • ProcedureTotal Knee Arthroplasty Medial Parapatellar Approach

    Incision splitting quad

  • ProcedureTotal Knee Arthroplasty Subvastus Approach

    quad-sparing approach

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What researchers measure

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

  5. Cadence (steps/minute)

    Continuously recorded from PIQ device after it is implanted during surgery

    Time frame: Through study completion, minimum 6 months

  6. Walking Speed (m/s)

    Continuously recorded from PIQ device after it is implanted during surgery

    Time frame: Through study completion, minimum 6 months

  7. Goniometric Functional Range of Motion

    Measured in degrees using a goniometer

    Time frame: Preoperatively and at 6 weeks

  8. Surgical Side

    Left or Right

    Time frame: Preoperatively

  9. Age

    In years, from EMR

    Time frame: Preoperatively

  10. Sex

    Male or Female, from EMR

    Time frame: Preoperatively

  11. Weight

    In kg, from EMR

    Time frame: Preoperatively

  12. Height

    In cm, from EMR

    Time frame: Preoperatively

  13. Body Mass Index (BMI)

    in kg/m2, from EMR

    Time frame: Preoperatively

  14. Comorbidities

    Collected and listed from EMR

    Time frame: Preoperatively

  15. Charlson Comorbidity Index (CCI)

    Calculated from formula using comorbidities collected from EMR

    Time frame: Preoperatively

  16. Time to Achieving Key Milestones in Daily Activities

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

    Time frame: 6 weeks postoperatively

  17. Veterans Rand 12-Item (VR-12) Health Survey

    Mental and Physical component survey scores collected (0-100); Survey via Force Therapeutics

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

  18. Procedure Satisfaction

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

    Time frame: 6 weeks postoperatively

  19. Numeric Pain Rating Scale (NPRS)

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

    Time frame: Preoperatively, 6 weeks postoperatively

  20. Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)

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

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

  21. Forgotten Joint Score (FJS)

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

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

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Study locations

1 site
  • Total Joint Surgery Center Atlanta
    Sandy Springs, Georgia 30328, United States
    • Zachary M Ricciardelli, B.S. · Contact · zach.ricciardelli@gmail.com · (615)-957-0334
    • · Contact · zach.ricciardelli@gmail.com
    • Thomas L Bradbury, M.D. · Principal investigator
    • Zachary M Ricciardelli, B.S. · Sub investigator
    • Charlotte C Baker, B.S. · Sub investigator
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References and documents

Publications

  • Matsueda M, Gustilo RB. Subvastus and medial parapatellar approaches in total knee arthroplasty. Clin Orthop Relat Res. 2000 Feb;(371):161-8. doi: 10.1097/00003086-200002000-00020. PubMed 10693563 ↗
  • Kazarian GS, Siow MY, Chen AF, Deirmengian CA. Comparison of Quadriceps-Sparing and Medial Parapatellar Approaches in Total Knee Arthroplasty: A Meta-Analysis of Randomized Controlled Trials. J Arthroplasty. 2018 Jan;33(1):277-283. doi: 10.1016/j.arth.2017.08.025. Epub 2017 Aug 30. PubMed 28947369 ↗
  • Cila E, Guzel V, Ozalay M, Tan J, Simsek SA, Kanatli U, Ozturk A. Subvastus versus medial parapatellar approach in total knee arthroplasty. Arch Orthop Trauma Surg. 2002 Mar;122(2):65-8. doi: 10.1007/s004020100319. PubMed 11880904 ↗
  • Tomek IM, Kantor SR, Cori LA, Scoville JM, Grove MR, Morgan TS, Swarup I, Moschetti WE, Spratt KF. Early Patient Outcomes After Primary Total Knee Arthroplasty with Quadriceps-Sparing Subvastus and Medial Parapatellar Techniques: A Randomized, Double-Blind Clinical Trial. J Bone Joint Surg Am. 2014 Jun 4;96(11):907-915. doi: 10.2106/JBJS.L.01578. Epub 2014 Jun 4. PubMed 24897738 ↗
  • Alcelik I, Sukeik M, Pollock R, Misra A, Naguib A, Haddad FS. Comparing the mid-vastus and medial parapatellar approaches in total knee arthroplasty: a meta-analysis of short term outcomes. Knee. 2012 Aug;19(4):229-36. doi: 10.1016/j.knee.2011.07.010. Epub 2011 Aug 20. PubMed 21862334 ↗
  • Khan MNH, Abbas K, Faraz A, Ilyas MW, Shafique H, Jamshed MH, Hashmi P. Total knee replacement: A comparison of the subvastus and medial parapatellar approaches. Ann Med Surg (Lond). 2021 Aug 8;68:102670. doi: 10.1016/j.amsu.2021.102670. eCollection 2021 Aug. PubMed 34408867 ↗
  • van Hemert WL, Senden R, Grimm B, van der Linde MJ, Lataster A, Heyligers IC. Early functional outcome after subvastus or parapatellar approach in knee arthroplasty is comparable. Knee Surg Sports Traumatol Arthrosc. 2011 Jun;19(6):943-51. doi: 10.1007/s00167-010-1292-0. Epub 2010 Oct 17. PubMed 20953864 ↗
  • Berstock JR, Murray JR, Whitehouse MR, Blom AW, Beswick AD. Medial subvastus versus the medial parapatellar approach for total knee replacement: A systematic review and meta-analysis of randomized controlled trials. EFORT Open Rev. 2018 Mar 26;3(3):78-84. doi: 10.1302/2058-5241.3.170030. eCollection 2018 Mar. PubMed 29657848 ↗

Study documents

  • Study protocol · Oct 31, 2025
  • Informed consent form · Oct 31, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Individual participant data will only be used as necessary by the authorized research team and always secured, it will not be shared

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07348835
Lead sponsor
Total Joint Specialists
Responsible party
Sponsor
First posted
Jan 16, 2026
Start date
Jan 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jan 16, 2026

Study contacts

Thomas L Bradbury, M.D.
Contact
tombradburymd@gmail.com
(404)-759-3912

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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