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

Part of paid clinical trials in Sandy Springs, Georgia.

Sponsor
Total Joint Specialists
Study ID
NCT07348835
Status
Not Yet Recruiting

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Conditions

  • Total Knee Anthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Total Knee Arthroplasty Medial Parapatellar Approach — PROCEDURE
    Incision splitting quad
  • Total Knee Arthroplasty Subvastus Approach — PROCEDURE
    quad-sparing approach

Study Details

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.

Key Dates

Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Medial Parapatellar Approach
    Primary total knee arthroplasty performed using the medial parapatellar surgical approach
  • Active Comparator: Subvastus Approach
    Primary total knee arthroplasty performed using the subvastus surgical approach

Primary Outcome Measure

Step Count (steps/day) [ Time Frame: Through study completion, minimum 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Total Joint Surgery Center AtlantaSandy SpringsGeorgia30328
Zachary M Ricciardelli, B.S.
[email protected]
(615)-957-0334
[email protected]
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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By research site
Total Joint Surgery Center Atlanta· Sandy Springs, GA

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