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

N/ANot Yet RecruitingNCT07348835

Total Joint Specialists110 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

110

Conditions

Total Knee Anthroplasty

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Step Count (steps/day)

Continuously recorded from PIQ device after it is implanted during surgery

Time frame: Through study completion, minimum 6 months

Step Count (steps/day)

Recorded from patients iPhone Health App for 2 weeks preoperatively

Time frame: Baseline

Secondary Outcomes

Stride Length (m)

Continuously recorded from PIQ device after it is implanted during surgery

Time frame: Through study completion, minimum 6 months

Distance Travelled (km)

Continuously recorded from PIQ device after it is implanted during surgery

Time frame: Through study completion, minimum 6 months

Functional Range of Motion (degrees)

Continuously recorded from PIQ device after it is implanted during surgery

Time frame: Through study completion, minimum 6 months

Tibial Range of Motion (degrees)

Continuously recorded from PIQ device after it is implanted during surgery

Time frame: Through study completion, minimum 6 months

Cadence (steps/minute)

Continuously recorded from PIQ device after it is implanted during surgery

Time frame: Through study completion, minimum 6 months

Walking Speed (m/s)

Continuously recorded from PIQ device after it is implanted during surgery

Time frame: Through study completion, minimum 6 months

Goniometric Functional Range of Motion

Measured in degrees using a goniometer

Time frame: Preoperatively and at 6 weeks

Surgical Side

Left or Right

Time frame: Preoperatively

Age

In years, from EMR

Time frame: Preoperatively

Sex

Male or Female, from EMR

Time frame: Preoperatively

Weight

In kg, from EMR

Time frame: Preoperatively

Height

In cm, from EMR

Time frame: Preoperatively

Body Mass Index (BMI)

in kg/m2, from EMR

Time frame: Preoperatively

Comorbidities

Collected and listed from EMR

Time frame: Preoperatively

Charlson Comorbidity Index (CCI)

Calculated from formula using comorbidities collected from EMR

Time frame: Preoperatively

Time to Achieving Key Milestones in Daily Activities

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

Time frame: 6 weeks postoperatively

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

Procedure Satisfaction

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

Time frame: 6 weeks postoperatively

Numeric Pain Rating Scale (NPRS)

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

Time frame: Preoperatively, 6 weeks postoperatively

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

Forgotten Joint Score (FJS)

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts