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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UNKNOWN
50 participants
OBSERVATIONAL
2021-08-13
2023-12-31
Brief Summary
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Detailed Description
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The patients are equally divided in two groups; patients in group 1 will receive traditional, manual soft-tissue balancing during surgery. For the purpose of the study, the balance will be quantitatively assessed at the end of the case, by means of surgeon-blinded VERASENSE measurements before and after cementation. For the patients in Group 2, intra-operative sensor feedback will be used in creating a quantitatively balanced knee (VERASENSE, OrthoSensor Inc.). Thereby, a quantitatively balanced knee is characterized by a mediolateral load differential below 15lbs at 10-45-90 degrees of flexion.
Post-operatively, the patients will be evaluated using the Muvr device at the day of surgery, day of discharge and 2, 6, and 12 weeks, and 1 year postoperatively. This device will provide quantitative feedback on different gait metrics as well as function during activities of daily living such as stair climbing / stair descent, walking, and timed get up and go testing.
During each post-operative visit, the following metrics will be recorded:
* Active and passive range of motion
* Implant alignment
* Patient reported outcomes by means of Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Forgotten Joint Score (FJS)
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1-Traditional soft tissue balance
Patients in group 1 will receive traditional, manual soft-tissue balancing during surgery. For the purpose of the study, the balance will be quantitatively assessed at the end of the case, by means of surgeon-blinded VERASENSE measurements before and after cementation.
Persona Trabecular Metal Tibia
Total knee arthroplasty
Verasense technology
Instrumented tibial trial component
MUVR
Knee motion and gait sensing wearable device
Group 2-Soft tissue balance using VERASENSE
For the patients in Group 2, intra-operative sensor feedback will be used in creating a quantitatively balanced knee (VERASENSE, OrthoSensor Inc.). Thereby, a quantitatively balanced knee is characterized by a mediolateral load differential below 15lbs at 10-45-90 degrees of flexion.
Persona Trabecular Metal Tibia
Total knee arthroplasty
Verasense technology
Instrumented tibial trial component
MUVR
Knee motion and gait sensing wearable device
Interventions
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Persona Trabecular Metal Tibia
Total knee arthroplasty
Verasense technology
Instrumented tibial trial component
MUVR
Knee motion and gait sensing wearable device
Eligibility Criteria
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Inclusion Criteria
2. Patient is willing and able to provide written Informed Consent prior to study surgery
3. Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form
Exclusion Criteria
2. Patient does not have access to internet or mobile device or understand how to use phone/app
3. Patient is not eligible or will not receive the Persona total knee system
4. Patient has not provided written Informed Consent
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Washington Hospital Healthcare System
OTHER
Responsible Party
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Alexander Sah, MD
Physician and Research Chair, Institute for Joint Restoration and Research
Locations
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Washington Hospital
Fremont, California, United States
Countries
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Central Contacts
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Facility Contacts
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Alexander Sah, MD
Role: primary
Other Identifiers
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IRU2018-51K
Identifier Type: -
Identifier Source: org_study_id
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