Total Knee Anthroplasty
Conditions
Keywords
Total Knee Arthroplasty, Medial Parapatellar Approach, Subvastus Approach
Brief 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.
Interventions
PROCEDURETotal Knee Arthroplasty Medial Parapatellar Approach
Incision splitting quad
PROCEDURETotal Knee Arthroplasty Subvastus Approach
quad-sparing approach
Sponsors
Total Joint Specialists
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This is a prospective, randomized, parallel-group study. Eligible patients undergoing primary total knee arthroplasty are randomized in a 1:1 ratio to either the medial parapatellar or subvastus surgical approach and followed concurrently. Outcomes are assessed longitudinally.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Step Count (steps/day) | Through study completion, minimum 6 months | Continuously recorded from PIQ device after it is implanted during surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stride Length (m) | Through study completion, minimum 6 months | Continuously recorded from PIQ device after it is implanted during surgery |
| Distance Travelled (km) | Through study completion, minimum 6 months | Continuously recorded from PIQ device after it is implanted during surgery |
| Functional Range of Motion (degrees) | Through study completion, minimum 6 months | Continuously recorded from PIQ device after it is implanted during surgery |
| Tibial Range of Motion (degrees) | Through study completion, minimum 6 months | Continuously recorded from PIQ device after it is implanted during surgery |
| Cadence (steps/minute) | Through study completion, minimum 6 months | Continuously recorded from PIQ device after it is implanted during surgery |
| Walking Speed (m/s) | Through study completion, minimum 6 months | Continuously recorded from PIQ device after it is implanted during surgery |
| Goniometric Functional Range of Motion | Preoperatively and at 6 weeks | Measured in degrees using a goniometer |
| Surgical Side | Preoperatively | Left or Right |
| Age | Preoperatively | In years, from EMR |
| Sex | Preoperatively | Male or Female, from EMR |
| Weight | Preoperatively | In kg, from EMR |
| Height | Preoperatively | In cm, from EMR |
| Body Mass Index (BMI) | Preoperatively | in kg/m2, from EMR |
| Comorbidities | Preoperatively | Collected and listed from EMR |
| Charlson Comorbidity Index (CCI) | Preoperatively | Calculated from formula using comorbidities collected from EMR |
| Time to Achieving Key Milestones in Daily Activities | 6 weeks postoperatively | Survey score collected (less time = better), Survey via Force Therapeutics |
| Veterans Rand 12-Item (VR-12) Health Survey | Preoperatively, 6 weeks postoperatively, 6 months postoperatively | Mental and Physical component survey scores collected (0-100); Survey via Force Therapeutics |
| Numeric Pain Rating Scale (NPRS) | Preoperatively, 6 weeks postoperatively | Survey score collected (0-10; 0 best), Survey via Force Therapeutics |
| Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) | Preoperatively, 6 weeks postoperatively, 6 months postoperatively | Survey score collected (0-100; 100 best), Survey via Force Therapeutics |
| Procedure Satisfaction | 6 weeks postoperatively | Survey score collected (0-5; 5 best), Survey via Force Therapeutics |
| Forgotten Joint Score (FJS) | Preoperatively, 6 weeks postoperatively, 6 months postoperatively | Survey score collected (0-100; 100 best), Survey via Force Therapeutics |
Countries
United States
Contacts
CONTACTThomas L Bradbury, M.D.
Outcome results
None listed