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

Официальное название

Continuous Monitoring Using a Smart Implantable Device (Persona IQ®) to Compare Medial Parapatellar vs. Subvastus Approaches in Early Post-Operative Total Knee Arthroplasty Recovery

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Step Count (steps/day) [Срок оценки: Through study completion, minimum 6 months]
• Step Count (steps/day) [Срок оценки: Baseline]

Вторичные конечные точки (12)

• Stride Length (m) [Срок оценки: Through study completion, minimum 6 months]
• Distance Travelled (km) [Срок оценки: Through study completion, minimum 6 months]
• Functional Range of Motion (degrees) [Срок оценки: Through study completion, minimum 6 months]
• Tibial Range of Motion (degrees) [Срок оценки: Through study completion, minimum 6 months]
• Cadence (steps/minute) [Срок оценки: Through study completion, minimum 6 months]
• Walking Speed (m/s) [Срок оценки: Through study completion, minimum 6 months]
• Goniometric Functional Range of Motion [Срок оценки: Preoperatively and at 6 weeks]
• Surgical Side [Срок оценки: Preoperatively]
• Age [Срок оценки: Preoperatively]
• Sex [Срок оценки: Preoperatively]
• Weight [Срок оценки: Preoperatively]
• Height [Срок оценки: Preoperatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Total Joint Surgery Center Atlanta — Sandy Springs

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 29657848

Идентификаторы

NCT: NCT07348835 · NSH1432

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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