Using a Smart Implantable Device to Compare Early Recovery in Two Different Knee Arthroplasty Approaches
NCT ID: NCT07348835
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
110 participants
INTERVENTIONAL
2026-01-31
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Medial Parapatellar Approach
Primary total knee arthroplasty performed using the medial parapatellar surgical approach
Total Knee Arthroplasty Medial Parapatellar Approach
Incision splitting quad
Subvastus Approach
Primary total knee arthroplasty performed using the subvastus surgical approach
Total Knee Arthroplasty Subvastus Approach
quad-sparing approach
Interventions
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Total Knee Arthroplasty Medial Parapatellar Approach
Incision splitting quad
Total Knee Arthroplasty Subvastus Approach
quad-sparing approach
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Total Joint Specialists
NETWORK
Responsible Party
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Locations
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Total Joint Surgery Center Atlanta
Sandy Springs, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
References
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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.
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.
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.
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.
Sukeik M, Sohail MZ, Hossain FS, AlShryda S, Powell J. Comparing the Sub-Vastus and Medial Parapatellar Approaches in Total Knee Arthroplasty: A Meta-Analysis of Short-Term Outcomes. Dr Sulaiman Al Habib Med J. 2021;3(2):66. doi:10.2991/dsahmj.k.210203.001
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.
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.
Ambrosino C, Ubertalle A, Liberatori J, Sarra C. [Proteins of milk sera. VI. Research by microimmunodiffusion in agar gel on immunochemical behavior of the sera of cow, sheep, goat and buffalo milk]. Ric Sci 2 Ser Pt 2 Rend B. 1965 Apr-Jun;6(2):125-34. No abstract available. Italian.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
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Other Identifiers
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NSH1432
Identifier Type: -
Identifier Source: org_study_id
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