Gait Analysis of a Lateral-Pivot Design Total Knee Replacement
NCT ID: NCT04275362
Last Updated: 2022-05-06
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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RECRUITING
102 participants
OBSERVATIONAL
2017-02-02
2029-01-02
Brief Summary
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Detailed Description
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Data were previously collected preoperatively, at 6 months and 1 year post-operatively for 16 patients who received a Stryker Triathlon total knee replacement and preoperatively and 1 year post-op for 16 patients who received a Biomet Vanguard total knee replacement. Data were also previously collected for 20 age matched healthy controls subjects. Data will be collected for an additional 20 control subjects. Knee Society Score (KSS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) will be collected at pre-op, 6 months, 1 year, and 2 years post-op. Gait analysis data will include kinetic, kinematic, temporal spatial, and electromyographic (EMG) data throughout the gait cycle for both research subjects and controls. Reflective markers will be placed on subject's anatomical landmarks, and ten surface EMG electrodes placed according to published standards (8). Subjects will walk at a self-selected speed down a runway embedded with force plates while 10 Eagle-4 digital infrared cameras record their movement. In addition to the level surface walking, additional data on more complex activities of daily living will be collected for potential future analysis. This would include: sit-to-stand, balance, and stair-climbing measurements also using the force plates, camera system and EMG data collection.
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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DJO subjects for surgical technique
Subjects who meet the inclusion criteria and receive a DJO Empowr total knee replacement but will not participate in motion data collection
DJO Empowr PS Knee System
Patients will receive a DJO Empowr PS Knee System total knee replacement
DJO subjects for data collection
Subjects who meet the inclusion criteria and consent to be in the study will receive a DJO Empowr total knee replacement and participate in motion data collections at pre-op, and 6 and 12 months post-op. Subjects will also participate in pre-op, 6 month, 1 year, 2 year, 5 year, and 10 year post-op clinical data collections
DJO Empowr PS Knee System
Patients will receive a DJO Empowr PS Knee System total knee replacement
Prospective control subjects
Healthy age matched subjects who did not have any knee osteoarthritis and participated in motion data collections.
Control
No total knee replacement
Stryker TKA subjects
Subjects who met the inclusion criteria and consented to be in a study whereby they received a Stryker Triathlon total knee replacement and participated in motion analysis pre-surgery and 6 and 12 months post-surgery.
Stryker Triathlon Total Knee System
Patients received a Stryker Triathlon Total Knee System total knee replacement
Biomet TKA subjects
Subjects who met the inclusion criteria and consented to be in a study whereby they received a Biomet Vanguard total knee replacement and participated in motion analysis pre-surgery and 12 months post-surgery.
Biomet Vanguard Complete Knee System
Patients received a Biomet Vanguard Complete Knee System total knee replacement
Retrospective control subjects
Healthy age matched subjects who did not have any knee osteoarthritis and participated in motion data collections.
Control
No total knee replacement
Interventions
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DJO Empowr PS Knee System
Patients will receive a DJO Empowr PS Knee System total knee replacement
Stryker Triathlon Total Knee System
Patients received a Stryker Triathlon Total Knee System total knee replacement
Biomet Vanguard Complete Knee System
Patients received a Biomet Vanguard Complete Knee System total knee replacement
Control
No total knee replacement
Eligibility Criteria
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Inclusion Criteria
1. At least 50 years of age.
2. Subjects who provide signed and IRB approved informed consent for gait analysis data collection
Retrospective subjects:
1. Subjects who had primary total knee replacement with either Stryker Triathlon Total Knee System or Biomet Vanguard Complete Knee System.
2. Subjects at least 50 years of age at the time of the surgery.
3. Subjects who previously provided signed and informed consent for gait analysis data collection under approval of the Sun Health Institutional Review Board
4. Cases that followed product labeling.
Prospective subjects:
1. Subjects who are eligible for DJO Global's Empowr total knee replacement.
2. Subjects at least 50 years of age at the time of the surgery.
3. Subjects who are willing to provide signed and IRB approved informed consent for gait analysis data collection.
4. Cases that followed product labeling.
Exclusion Criteria
1. Controls with any musculoskeletal injury or disorder.
2. Controls that are pregnant or planning on becoming pregnant.
3. Controls with a BMI\>40
Retrospective subjects:
1. Subjects with inflammatory arthritis or psoriatic arthritis at the time of surgery.
2. Subjects that are pregnant or planning on becoming pregnant.
3. Subjects with a BMI\>40
4. Subjects who had an active infection or suspected latent infection in or about the joint at the time of surgery.
5. Subjects whose bone stock was compromised by disease, infection or prior implantation which could not provide adequate support and/or fixation of the prosthesis.
6. Subjects who had any mental or neuromuscular disorders which created an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complication in postoperative care.
7. Subjects with severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
Prospective subjects:
1. Subjects with inflammatory arthritis or psoriatic arthritis at the time of surgery.
2. Subjects that are pregnant or planning on becoming pregnant.
3. Subjects with a BMI\>40
4. Subjects who had an active infection or suspected latent infection in or about the joint at the time of surgery.
5. Subjects whose bone stock was compromised by disease, infection or prior implantation which could not provide adequate support and/or fixation of the prosthesis.
6. Subjects who had any mental or neuromuscular disorders which created an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complication in postoperative care.
7. Subjects with severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
50 Years
ALL
Yes
Sponsors
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Encore Medical, L.P.
INDUSTRY
More Foundation
OTHER
Responsible Party
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Principal Investigators
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Scott Siverhus, MD
Role: PRINCIPAL_INVESTIGATOR
The CORE Institute
Locations
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MORE Foundation
Phoenix, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4015
Identifier Type: -
Identifier Source: org_study_id
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