- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04275362
Gait Analysis of a Lateral-Pivot Design Total Knee Replacement
Study Overview
Status
Conditions
Detailed Description
Thirty subjects who are scheduled to receive an Empowr PS Total Knee Replacement device will be consented to be in the prospective component of the study. Twenty of these patients will participate in motion data collection. These patients will all be scheduled to undergo primary total knee replacement using the Empowr device. All surgeries will be performed using computer navigation. Patients will receive standardized physical therapy to insure consistency of rehab protocols and discharge from physical therapy criteria. Specifically, patients will be monitored for visit compliance, Timed Up and Go (TUG) test in seconds, AROM in degrees, and walking un-aided.
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: John D McCamley, PhD
- Phone Number: 623.241.5472
- Email: john.mccamley@more-foundation.org
Study Contact Backup
- Name: Debra Sietsema, PhD
- Phone Number: 623.455.7109
- Email: debra.sietsema@more-foundation.org
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85023
- Recruiting
- More Foundation
-
Contact:
- Debra Sietsema, PhD
- Phone Number: 623.455.7109
- Email: debra.sietsema@more-foundation.org
-
Contact:
- John D McCamley, PhD
- Phone Number: 623-241-8721
- Email: john.mccamley@more-foundation.org
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Controls:
- At least 50 years of age.
- Subjects who provide signed and IRB approved informed consent for gait analysis data collection
Retrospective subjects:
- Subjects who had primary total knee replacement with either Stryker Triathlon Total Knee System or Biomet Vanguard Complete Knee System.
- Subjects at least 50 years of age at the time of the surgery.
- Subjects who previously provided signed and informed consent for gait analysis data collection under approval of the Sun Health Institutional Review Board
- Cases that followed product labeling.
Prospective subjects:
- Subjects who are eligible for DJO Global's Empowr total knee replacement.
- Subjects at least 50 years of age at the time of the surgery.
- Subjects who are willing to provide signed and IRB approved informed consent for gait analysis data collection.
- Cases that followed product labeling.
Exclusion Criteria:
Controls:
- Controls with any musculoskeletal injury or disorder.
- Controls that are pregnant or planning on becoming pregnant.
- Controls with a BMI>40
Retrospective subjects:
- Subjects with inflammatory arthritis or psoriatic arthritis at the time of surgery.
- Subjects that are pregnant or planning on becoming pregnant.
- Subjects with a BMI>40
- Subjects who had an active infection or suspected latent infection in or about the joint at the time of surgery.
- Subjects whose bone stock was compromised by disease, infection or prior implantation which could not provide adequate support and/or fixation of the prosthesis.
- Subjects who had any mental or neuromuscular disorders which created an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complication in postoperative care.
- Subjects with severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
Prospective subjects:
- Subjects with inflammatory arthritis or psoriatic arthritis at the time of surgery.
- Subjects that are pregnant or planning on becoming pregnant.
- Subjects with a BMI>40
- Subjects who had an active infection or suspected latent infection in or about the joint at the time of surgery.
- Subjects whose bone stock was compromised by disease, infection or prior implantation which could not provide adequate support and/or fixation of the prosthesis.
- Subjects who had any mental or neuromuscular disorders which created an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complication in postoperative care.
- Subjects with severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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
|
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.
|
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.
|
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.
|
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.
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No total knee replacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee flexion angle during swing
Time Frame: Pre-op
|
Compare maximum knee flexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
Pre-op
|
Knee flexion angle during swing
Time Frame: 6 months post-op
|
Compare maximum knee flexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
Knee flexion angle during swing
Time Frame: 12 months post-op
|
Compare maximum knee flexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
Knee flexion angle during stance
Time Frame: pre-op
|
Compare maximum knee flexion angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
pre-op
|
Knee flexion angle during stance
Time Frame: 6 months post-op
|
Compare maximum knee flexion angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
Knee flexion angle during stance
Time Frame: 12 months post-op
|
Compare maximum knee flexion angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
Knee adduction angle during stance
Time Frame: pre-op
|
Compare maximum knee adduction angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
pre-op
|
Knee adduction angle during stance
Time Frame: 6 months post-op
|
Compare maximum knee adduction angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
Knee adduction angle during stance
Time Frame: 12 months post-op
|
Compare maximum knee adduction angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.knee
replacement (DJO Empowr) and single-radius (Triathlon, Stryker) and multi-radius (Vanguard, Zimmer Biomet) knee replacements.
|
12 months post-op
|
Knee flexion moment
Time Frame: pre-op
|
Compare maximum knee flexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
pre-op
|
Knee flexion moment
Time Frame: 6 months post-op
|
Compare maximum knee flexion moment normalised to subject body weight (N-m/kg) during stance between between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
Knee flexion moment
Time Frame: 12 months post-op
|
Compare maximum knee flexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
Knee adduction moment
Time Frame: Pre-op
|
Compare maximum knee adduction moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
Pre-op
|
Knee adduction moment
Time Frame: 6 months post-op
|
Compare maximum knee adduction moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), oe a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
Knee adduction moment
Time Frame: 12 months post-op
|
Compare maximum knee adduction moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
Knee power
Time Frame: Pre-op
|
Compare maximum knee power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
Pre-op
|
Knee power
Time Frame: 6 month post-op
|
Compare maximum knee power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 month post-op
|
Knee power
Time Frame: 12 month post-op
|
Compare maximum knee power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 month post-op
|
Vertical GRF
Time Frame: pre-op
|
Compare maximum vertical ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
pre-op
|
Vertical GRF
Time Frame: 6 months post-op
|
Compare maximum vertical ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
Vertical GRF
Time Frame: 12 month post-op
|
Compare maximum vertical ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 month post-op
|
AP GRF
Time Frame: Pre-op
|
Compare maximum anterior-posterior ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
Pre-op
|
AP GRF
Time Frame: 6 months post-op
|
Compare maximum anterior-posterior ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
AP GRF
Time Frame: 12 months post-op
|
Compare maximum anterior-posterior ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
ML GRF
Time Frame: pre-op
|
Compare maximum medial-lateral ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
pre-op
|
ML GRF
Time Frame: 6 months post-op
|
Compare maximum anterior-posterior ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
ML GRF
Time Frame: 12 months post-op
|
Compare maximum anterior-posterior ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ankle dorsiflexion angle during swing
Time Frame: Pre-op
|
Compare maximum ankle dorsiflexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
Pre-op
|
Ankle dorsiflexion angle during swing
Time Frame: 6 months post-op
|
Compare maximum ankle dorsiflexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
Ankle dorsiflexion angle during swing
Time Frame: 12 months post-op
|
Compare maximum ankle dorsiflexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
Ankle plantarflexion angle during stance
Time Frame: pre-op
|
Compare maximum ankle plantarflexion angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
pre-op
|
Ankle plantarflexion angle during stance
Time Frame: 6 months post-op
|
Compare maximum ankle plantarflexion angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
Ankle plantarflexion angle during stance
Time Frame: 12 months post-op
|
Compare maximum ankle plantarflexion angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
Ankle plantarflexion moment during stance
Time Frame: pre-op
|
Compare maximum ankle plantarflexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
pre-op
|
Ankle plantarflexion moment during stance
Time Frame: 6 months post-op
|
Compare maximum ankle plantarflexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
Ankle plantarflexion moment during stance
Time Frame: 12 months post-op
|
Compare maximum ankle plantarflexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
Ankle power
Time Frame: Pre-op
|
Compare maximum ankle power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
Pre-op
|
Ankle power
Time Frame: 6 months post-op
|
Compare maximum ankle power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
Ankle power
Time Frame: 12 months post-op
|
Compare maximum ankle power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
Hip flexion maximum during swing
Time Frame: Pre-op
|
Compare hip flexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
Pre-op
|
Hip flexion during swing
Time Frame: 6 months post-op
|
Compare maximum hip flexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
Hip flexion during swing
Time Frame: 12 months post-op
|
Compare maximum hip flexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
Hip extension during stance
Time Frame: Pre-op
|
Compare maximum hip extension angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
Pre-op
|
Hip extension during stance
Time Frame: 6 months post-op
|
Compare maximum hip extension angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
6 months post-op
|
Hip extension during stance
Time Frame: 12 months post-op
|
Compare maximum hip extension angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
Hip flexion moment during stance
Time Frame: Pre-op
|
Compare maximum hip flexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
Pre-op
|
Hip flexion moment during stance
Time Frame: 6 months post-op
|
Compare maximum hip flexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
Hip flexion moment during stance
Time Frame: 12 months post-op
|
Compare maximum hip flexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
Hip power
Time Frame: Pre-op
|
Compare maximum hip power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
Pre-op
|
Hip power
Time Frame: 6 months post-op
|
Compare maximum hip power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
Hip power
Time Frame: 12 months post-op
|
Compare maximum hip power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
KSS
Time Frame: Pre-op
|
Compare Knee Society Score between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
Pre-op
|
KSS
Time Frame: 6 months post-op
|
Compare Knee Society Score between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
KSS
Time Frame: 12 months post-op
|
Compare Knee Society Score between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
LEAS
Time Frame: Pre-op
|
Compare Lower Extremity Activity Score between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
Pre-op
|
LEAS
Time Frame: 6 months post-op
|
Compare Lower Extremity Activity Score between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.
|
6 months post-op
|
LEAS
Time Frame: 12 months post-op
|
Compare Lower Extremity Activity Score between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.
|
12 months post-op
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott Siverhus, MD, The Core Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Cytochrome P-450 Enzyme Inhibitors
- Anti-Ulcer Agents
- Histamine Antagonists
- Histamine Agents
- Cytochrome P-450 CYP1A2 Inhibitors
- Histamine H2 Antagonists
- Cimetidine
Other Study ID Numbers
- 4015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Novartis PharmaceuticalsRecruitingSymptomatic Knee OsteoarthritisUnited States, Spain, Hungary, Argentina, Germany, Slovakia, Czechia, Belgium, Romania
-
University of BathUniversity of Oxford; 3D Metal Printing Ltd; Versus ArthritisRecruitingMedial Knee OsteoarthritisUnited Kingdom
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Max Biocare Pty. Ltd.Completed
Clinical Trials on DJO Empowr PS Knee System
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Canadian Radiostereometric Analysis NetworkDalhousie University; London Health Sciences Centre; Orthopaedic Innovation CentreCompletedKnee OsteoarthritisCanada
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Leiden University Medical CenterStryker NordicTerminatedAseptic Loosening | Complications; Arthroplasty, MechanicalNetherlands
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Smith & Nephew Medical (Shanghai) LtdCompletedRheumatoid Arthritis | Avascular Necrosis | Post-traumatic Arthritis | Primary OsteoarthritisChina
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Stryker OrthopaedicsCompletedArthroplasty, Replacement, KneeUnited States
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Restor3DTerminatedOsteoarthritis, KneeUnited States
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Leiden University Medical CenterZimmer BiometCompletedJoint Diseases | Musculoskeletal Diseases | Rheumatic Diseases | Osteoarthritis ArthritisNetherlands
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Zimmer BiometWithdrawnOsteoarthritis | Degenerative Arthritis
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Restor3DCompletedOsteo Arthritis KneeUnited States
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Zimmer BiometCompleted