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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medial Parapatellar Approach | Active Comparator | Primary total knee arthroplasty performed using the medial parapatellar surgical approach |
|
| Subvastus Approach | Active Comparator | Primary total knee arthroplasty performed using the subvastus surgical approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Arthroplasty Medial Parapatellar Approach | Procedure | Incision splitting quad |
|
| Measure | Description | Time Frame |
|---|---|---|
| Step Count (steps/day) | Continuously recorded from PIQ device after it is implanted during surgery | Through study completion, minimum 6 months |
| Step Count (steps/day) | Recorded from patients iPhone Health App for 2 weeks preoperatively | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Stride Length (m) | Continuously recorded from PIQ device after it is implanted during surgery | Through study completion, minimum 6 months |
| Distance Travelled (km) | Continuously recorded from PIQ device after it is implanted during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas L Bradbury, M.D. | Contact | (404)-759-3912 | tombradburymd@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Joint Surgery Center Atlanta | Sandy Springs | Georgia | 30328 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10693563 | Background | 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. | |
| 28947369 | Background | 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. |
| Label | URL |
|---|---|
| Persona IQ Device | View source |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 31, 2025 | Dec 15, 2025 |
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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.
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| Total Knee Arthroplasty Subvastus Approach | Procedure | quad-sparing approach |
|
| Through study completion, minimum 6 months |
| Functional Range of Motion (degrees) | Continuously recorded from PIQ device after it is implanted during surgery | Through study completion, minimum 6 months |
| Tibial Range of Motion (degrees) | Continuously recorded from PIQ device after it is implanted during surgery | Through study completion, minimum 6 months |
| Cadence (steps/minute) | Continuously recorded from PIQ device after it is implanted during surgery | Through study completion, minimum 6 months |
| Walking Speed (m/s) | Continuously recorded from PIQ device after it is implanted during surgery | Through study completion, minimum 6 months |
| Goniometric Functional Range of Motion | Measured in degrees using a goniometer | Preoperatively and at 6 weeks |
| Surgical Side | Left or Right | Preoperatively |
| Age | In years, from EMR | Preoperatively |
| Sex | Male or Female, from EMR | Preoperatively |
| Weight | In kg, from EMR | Preoperatively |
| Height | In cm, from EMR | Preoperatively |
| Body Mass Index (BMI) | in kg/m2, from EMR | Preoperatively |
| Comorbidities | Collected and listed from EMR | Preoperatively |
| Charlson Comorbidity Index (CCI) | Calculated from formula using comorbidities collected from EMR | Preoperatively |
| Time to Achieving Key Milestones in Daily Activities | Survey score collected (less time = better), Survey via Force Therapeutics | 6 weeks postoperatively |
| Veterans Rand 12-Item (VR-12) Health Survey | Mental and Physical component survey scores collected (0-100); Survey via Force Therapeutics | Preoperatively, 6 weeks postoperatively, 6 months postoperatively |
| Procedure Satisfaction | Survey score collected (0-5; 5 best), Survey via Force Therapeutics | 6 weeks postoperatively |
| Numeric Pain Rating Scale (NPRS) | Survey score collected (0-10; 0 best), Survey via Force Therapeutics | 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 | Preoperatively, 6 weeks postoperatively, 6 months postoperatively |
| Forgotten Joint Score (FJS) | Survey score collected (0-100; 100 best), Survey via Force Therapeutics | Preoperatively, 6 weeks postoperatively, 6 months postoperatively |
| 11880904 | Background | 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. |
| 24897738 | Background | 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. |
| 21862334 | Background | 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. |
| 34408867 | Background | 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. |
| 20953864 | Background | 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. |
| 29657848 | Background | 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. |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2025 | Dec 15, 2025 | ICF_001.pdf |