NCT04275362

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Feb 2017Jan 2029

Study Start

First participant enrolled

February 2, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2023

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2029

Expected
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

6.2 years

First QC Date

February 12, 2020

Last Update Submit

May 4, 2022

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritisTotal knee arthroplastyLateral pivot

Outcome Measures

Primary Outcomes (27)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    12 months post-op

Secondary Outcomes (30)

  • Ankle dorsiflexion angle during swing

    Pre-op

  • Ankle dorsiflexion angle during swing

    6 months post-op

  • Ankle dorsiflexion angle during swing

    12 months post-op

  • Ankle plantarflexion angle during stance

    pre-op

  • Ankle plantarflexion angle during stance

    6 months post-op

  • +25 more secondary outcomes

Study Arms (6)

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

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

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.

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.

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.

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.

Device: Control

Interventions

DJO Empowr PS Knee SystemDEVICE

Patients will receive a DJO Empowr PS Knee System total knee replacement

DJO subjects for data collectionDJO subjects for surgical technique
Stryker Triathlon Total Knee SystemDEVICE

Patients received a Stryker Triathlon Total Knee System total knee replacement

Stryker TKA subjects
Biomet Vanguard Complete Knee SystemDEVICE

Patients received a Biomet Vanguard Complete Knee System total knee replacement

Biomet TKA subjects
ControlDEVICE

No total knee replacement

Prospective control subjectsRetrospective control subjects

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MORE Foundation

Phoenix, Arizona, 85023, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Scott Siverhus, MD

    The CORE Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John D McCamley, PhD

CONTACT

623.241.5472john.mccamley@more-foundation.org

Debra Sietsema, PhD

CONTACT

623.455.7109debra.sietsema@more-foundation.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 19, 2020

Study Start

February 2, 2017

Primary Completion

April 2, 2023

Study Completion (Estimated)

January 2, 2029

Last Updated

May 6, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)