Knee OsteoarthritisNCT04275362
Gait Analysis of a Lateral-Pivot Design Total Knee Replacement
An observational study of Knee Osteoarthritis, run by More Foundation at 1 site in United States.
Trial summary
Previous motion analysis studies have demonstrated excellent ability to distinguish subtle differences in gait between normal subjects and those suffering from arthritis. With proper techniques and analysis differences between osteoarthritis patient groups can be distinguished. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- DJO Empowr PS Knee System, Stryker Triathlon Total Knee System and Biomet Vanguard Complete Knee System
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2017to 2 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of 4 groups: 1) Healthy age matched controls, 2) Retrospective subjects who have previously received either a Stryker Triathlon TKA or a Biomet Vanguard TKA and participated in IRB approved gait analysis at pre-op, 6 month, and 12 month post-op time points
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MORE Foundation
Phoenix, Arizona, 85023
John D McCamley, PhD, 623-241-8721, john.mccamley@more-foundation.org
Debra Sietsema, PhD, 623.455.7109, debra.sietsema@more-foundation.org
About this study
Previous motion analysis studies have demonstrated excellent ability to distinguish subtle differences in gait between normal subjects and those suffering from arthritis. With proper techniques and analysis differences between osteoarthritis patient groups can be distinguished. Previous research has indicated that subjects who received a single-radius design total knee replacement have superior gait performance that those who received a multi-radius design total knee replacement. The DJO Global Empowr PS Knee System is a single-radius lateral pivot design. This design should achieve reproducible more natural knee function and improved patient outcomes and satisfaction. A motion analysis laboratory will be used to collect gait data from patients who are going to receive a Empowr PS knee device and also from age-matched control subjects. These data will be compared with data previously collected from patients who received Stryker Triathlon devices, Biomet Vanguard devices and age-matched healthy control subjects.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- DJO Empowr PS Knee System, Stryker Triathlon Total Knee System, Biomet Vanguard Complete Knee System, Control
- Keywords
- Knee osteoarthritis, Total knee arthroplasty, Lateral pivot
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DJO Empowr PS Knee SystemDevice
Patients will receive a DJO Empowr PS Knee System total knee replacement
Stryker Triathlon Total Knee SystemDevice
Patients received a Stryker Triathlon Total Knee System total knee replacement
Biomet Vanguard Complete Knee SystemDevice
Patients received a Biomet Vanguard Complete Knee System total knee replacement
ControlDevice
No total knee replacement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: DJO Empowr PS Knee System | |
| 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 Receives: Device: DJO Empowr PS Knee System | |
| Prospective control subjects | Healthy age matched subjects who did not have any knee osteoarthritis and participated in motion data collections. Receives: Device: Control | |
| 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. Receives: Device: Stryker Triathlon Total Knee System | |
| 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. Receives: Device: Biomet Vanguard Complete Knee System | |
| Retrospective control subjects | Healthy age matched subjects who did not have any knee osteoarthritis and participated in motion data collections. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee flexion angle during swing
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.
Measured: Pre-op
Knee flexion angle during swing
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.
Measured: 6 months post-op
Knee flexion angle during swing
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.
Measured: 12 months post-op
Knee flexion angle during stance
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.
Measured: pre-op
Knee flexion angle during stance
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.
Measured: 6 months post-op
Knee flexion angle during stance
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.
Measured: 12 months post-op
Knee adduction angle during stance
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.
Measured: pre-op
Knee adduction angle during stance
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.
Measured: 6 months post-op
Knee adduction angle during stance
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.
Measured: 12 months post-op
Knee flexion moment
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.
Measured: pre-op
Knee flexion moment
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.
Measured: 6 months post-op
Knee flexion moment
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.
Measured: 12 months post-op
Knee adduction moment
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.
Measured: Pre-op
Knee adduction moment
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.
Measured: 6 months post-op
Knee adduction moment
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.
Measured: 12 months post-op
Knee power
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.
Measured: Pre-op
Knee power
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.
Measured: 6 month post-op
Knee power
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.
Measured: 12 month post-op
Vertical GRF
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.
Measured: pre-op
Vertical GRF
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.
Measured: 6 months post-op
Vertical GRF
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.
Measured: 12 month post-op
AP GRF
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.
Measured: Pre-op
AP GRF
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.
Measured: 6 months post-op
AP GRF
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.
Measured: 12 months post-op
ML GRF
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.
Measured: pre-op
ML GRF
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.
Measured: 6 months post-op
ML GRF
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.
Measured: 12 months post-op
Secondary outcomes (30)
Ankle dorsiflexion angle during swing
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.
Measured: Pre-op
Ankle dorsiflexion angle during swing
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.
Measured: 6 months post-op
Ankle dorsiflexion angle during swing
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.
Measured: 12 months post-op
Ankle plantarflexion angle during stance
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.
Measured: pre-op
Ankle plantarflexion angle during stance
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.
Measured: 6 months post-op
Ankle plantarflexion angle during stance
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.
Measured: 12 months post-op
Ankle plantarflexion moment during stance
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.
Measured: pre-op
Ankle plantarflexion moment during stance
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.
Measured: 6 months post-op
Ankle plantarflexion moment during stance
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.
Measured: 12 months post-op
Ankle power
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.
Measured: Pre-op
Ankle power
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.
Measured: 6 months post-op
Ankle power
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.
Measured: 12 months post-op
Hip flexion maximum during swing
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.
Measured: Pre-op
Hip flexion during swing
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.
Measured: 6 months post-op
Hip flexion during swing
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.
Measured: 12 months post-op
Hip extension during stance
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.
Measured: Pre-op
Hip extension during stance
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.
Measured: 6 months post-op
Hip extension during stance
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.
Measured: 12 months post-op
Hip flexion moment during stance
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.
Measured: Pre-op
Hip flexion moment during stance
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.
Measured: 6 months post-op
Hip flexion moment during stance
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.
Measured: 12 months post-op
Hip power
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.
Measured: Pre-op
Hip power
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.
Measured: 6 months post-op
Hip power
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.
Measured: 12 months post-op
KSS
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.
Measured: Pre-op
KSS
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.
Measured: 6 months post-op
KSS
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.
Measured: 12 months post-op
LEAS
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.
Measured: Pre-op
LEAS
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.
Measured: 6 months post-op
LEAS
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.
Measured: 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start2 Feb 2017
- Primary completion2 Apr 2023 (estimated)
- Study completion2 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- More Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Encore Medical, L.P.
- Responsible party
- Sponsor
- Investigators
- Scott Siverhus, MD, Principal investigator, The CORE Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275362
- Sponsor's protocol ID
- 4015
- Status last verified
- May 2022
- First submitted
- 12 Feb 2020
- Last updated
- 6 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Analysis of a Lateral-Pivot Design Total Knee Replacement
- ClinicalTrials.gov ID
- NCT04275362
- Acronym / sponsor ID
- 4015
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Total knee arthroplasty, Lateral pivot
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- More FoundationUniversity, hospital or other
- Collaborators
- Encore Medical, L.P.
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 2 Apr 2023 (estimated)
- Study completion
- 2 Jan 2029 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous motion analysis studies have demonstrated excellent ability to distinguish subtle differences in gait between normal subjects and those suffering from arthritis. With proper techniques and analysis differences between osteoarthritis patient groups can be distinguished. Previous research has indicated that subjects who received a single-radius design total knee replacement have superior gait performance that those who received a multi-radius design total knee replacement. The DJO Global Empowr PS Knee System is a single-radius lateral pivot design. This design should achieve reproducible more natural knee function and improved patient outcomes and satisfaction. A motion analysis laboratory will be used to collect gait data from patients who are going to receive a Empowr PS knee device and also from age-matched control subjects. These data will be compared with data previously collected from patients who received Stryker Triathlon devices, Biomet Vanguard devices and age-matched healthy control subjects.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| DJO subjects for surgical technique | – | Device: DJO Empowr PS Knee SystemSubjects who meet the inclusion criteria and receive a DJO Empowr total knee replacement but will not participate in motion data collection |
| DJO subjects for data collection | – | Device: DJO Empowr PS Knee SystemSubjects 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 |
| Prospective control subjects | – | Device: ControlHealthy age matched subjects who did not have any knee osteoarthritis and participated in motion data collections. |
| Stryker TKA subjects | – | Device: Stryker Triathlon Total Knee SystemSubjects 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. |
| Biomet TKA subjects | – | Device: Biomet Vanguard Complete Knee SystemSubjects 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. |
| Retrospective control subjects | – | Device: ControlHealthy age matched subjects who did not have any knee osteoarthritis and participated in motion data collections. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 4 groups: 1) Healthy age matched controls, 2) Retrospective subjects who have previously received either a Stryker Triathlon TKA or a Biomet Vanguard TKA and participated in IRB approved gait analysis at pre-op, 6 month, and 12 month post-op time points
Key inclusion criteria (13 listed)
- At least 50 years of age.
- Subjects who provide signed and IRB approved informed consent for gait analysis data collection
- 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
Key exclusion criteria (20 listed)
- Controls with any musculoskeletal injury or disorder.
- Controls that are pregnant or planning on becoming pregnant.
- Controls with a BMI>40
- Subjects with inflammatory arthritis or psoriatic arthritis at the time of surgery.
- Subjects that are pregnant or planning on becoming pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DJO Empowr PS Knee SystemPatients will receive a DJO Empowr PS Knee System total knee replacement | Device | DJO subjects for data collection, DJO subjects for surgical technique |
| Stryker Triathlon Total Knee SystemPatients received a Stryker Triathlon Total Knee System total knee replacement | Device | Stryker TKA subjects |
| Biomet Vanguard Complete Knee SystemPatients received a Biomet Vanguard Complete Knee System total knee replacement | Device | Biomet TKA subjects |
| ControlNo total knee replacement | Device | Prospective control subjects, Retrospective control subjects |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
30 secondary outcomes
Ankle dorsiflexion angle during swing
Time frame: Pre-op
Ankle dorsiflexion angle during swing
Time frame: 6 months post-op
Ankle dorsiflexion angle during swing
Time frame: 12 months post-op
Ankle plantarflexion angle during stance
Time frame: pre-op
Ankle plantarflexion angle during stance
Time frame: 6 months post-op
Ankle plantarflexion angle during stance
Time frame: 12 months post-op
Ankle plantarflexion moment during stance
Time frame: pre-op
Ankle plantarflexion moment during stance
Time frame: 6 months post-op
Ankle plantarflexion moment during stance
Time frame: 12 months post-op
Ankle power
Time frame: Pre-op
Ankle power
Time frame: 6 months post-op
Ankle power
Time frame: 12 months post-op
Hip flexion maximum during swing
Time frame: Pre-op
Hip flexion during swing
Time frame: 6 months post-op
Hip flexion during swing
Time frame: 12 months post-op
Hip extension during stance
Time frame: Pre-op
Hip extension during stance
Time frame: 6 months post-op
Hip extension during stance
Time frame: 12 months post-op
Hip flexion moment during stance
Time frame: Pre-op
Hip flexion moment during stance
Time frame: 6 months post-op
Hip flexion moment during stance
Time frame: 12 months post-op
Hip power
Time frame: Pre-op
Hip power
Time frame: 6 months post-op
Hip power
Time frame: 12 months post-op
KSS
Time frame: Pre-op
KSS
Time frame: 6 months post-op
KSS
Time frame: 12 months post-op
LEAS
Time frame: Pre-op
LEAS
Time frame: 6 months post-op
LEAS
Time frame: 12 months post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott Siverhus, MD principal investigator
The CORE Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by More Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John D McCamley, PhD (623.241.5472, john.mccamley@more-foundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee flexion angle during swing (time frame: Pre-op). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.