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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Total Knee Anthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Medial Parapatellar Approach

Primary total knee arthroplasty performed using the medial parapatellar surgical approach

Group Type ACTIVE_COMPARATOR

Total Knee Arthroplasty Medial Parapatellar Approach

Intervention Type PROCEDURE

Incision splitting quad

Subvastus Approach

Primary total knee arthroplasty performed using the subvastus surgical approach

Group Type ACTIVE_COMPARATOR

Total Knee Arthroplasty Subvastus Approach

Intervention Type PROCEDURE

quad-sparing approach

Interventions

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Total Knee Arthroplasty Medial Parapatellar Approach

Incision splitting quad

Intervention Type PROCEDURE

Total Knee Arthroplasty Subvastus Approach

quad-sparing approach

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Total Joint Specialists

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Total Joint Surgery Center Atlanta

Sandy Springs, Georgia, United States

Site Status

Countries

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United States

Central Contacts

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Thomas L Bradbury, M.D.

Role: CONTACT

(404)-759-3912

Facility Contacts

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Zachary M Ricciardelli, B.S.

Role: primary

(615)-957-0334

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.

Reference Type BACKGROUND
PMID: 10693563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28947369 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11880904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24897738 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 34408867 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20953864 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5890136 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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NSH1432

Identifier Type: -

Identifier Source: org_study_id

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