Recruiting

Observational Study

Sponsor:

More Foundation

Code:

NCT04275362

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

DJO Empowr PS Knee System

Stryker Triathlon Total Knee System

Biomet Vanguard Complete Knee System

Control

Study Details

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.

Conditions

Knee Osteoarthritis

Study ID

NCT04275362

Start date

Feb 2, 2017

Status verified date

May, 2022

Completion date

Jan 2, 2029

Anticipated

Primary completion date

Apr 2, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Inclusion Criteria:

Controls:

1. At least 50 years of age.
2. Subjects who provide signed and IRB approved informed consent for gait analysis data collection

Retrospective subjects:

1. Subjects who had primary total knee replacement with either Stryker Triathlon Total Knee System or Biomet Vanguard Complete Knee System.
2. Subjects at least 50 years of age at the time of the surgery.
3. Subjects who previously provided signed and informed consent for gait analysis data collection under approval of the Sun Health Institutional Review Board
4. Cases that followed product labeling.

Prospective subjects:

1. Subjects who are eligible for DJO Global's Empowr total knee replacement.
2. Subjects at least 50 years of age at the time of the surgery.
3. Subjects who are willing to provide signed and IRB approved informed consent for gait analysis data collection.
4. Cases that followed product labeling.

Exclusion Criteria:

Controls:

1. Controls with any musculoskeletal injury or disorder.
2. Controls that are pregnant or planning on becoming pregnant.
3. Controls with a BMI>40

Retrospective subjects:

1. Subjects with inflammatory arthritis or psoriatic arthritis at the time of surgery.
2. Subjects that are pregnant or planning on becoming pregnant.
3. Subjects with a BMI>40
4. Subjects who had an active infection or suspected latent infection in or about the joint at the time of surgery.
5. Subjects whose bone stock was compromised by disease, infection or prior implantation which could not provide adequate support and/or fixation of the prosthesis.
6. Subjects who had any mental or neuromuscular disorders which created an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complication in postoperative care.
7. Subjects with severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.

Prospective subjects:

1. Subjects with inflammatory arthritis or psoriatic arthritis at the time of surgery.
2. Subjects that are pregnant or planning on becoming pregnant.
3. Subjects with a BMI>40
4. Subjects who had an active infection or suspected latent infection in or about the joint at the time of surgery.
5. Subjects whose bone stock was compromised by disease, infection or prior implantation which could not provide adequate support and/or fixation of the prosthesis.
6. Subjects who had any mental or neuromuscular disorders which created an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complication in postoperative care.
7. Subjects with severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.

Study Design

Enrollment

102 participants

Anticipated

Interventions and Outcome Measures

Arms

DJO subjects for surgical technique

Subjects who meet the inclusion criteria and receive a DJO Empowr total knee replacement but will not participate in motion data collection

DJO 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

Prospective control subjects

Healthy age matched subjects who did not have any knee osteoarthritis and participated in motion data collections.

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.

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.

Retrospective control subjects

Healthy age matched subjects who did not have any knee osteoarthritis and participated in motion data collections.

Interventions

DJO Empowr PS Knee System

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

Stryker Triathlon Total Knee System

Patients received a Stryker Triathlon Total Knee System total knee replacement

Biomet Vanguard Complete Knee System

Patients received a Biomet Vanguard Complete Knee System total knee replacement

Control

No total knee replacement

Primary outcome measure

  • Knee flexion angle during swing [ Time Frame: Pre-op ]
  • Knee flexion angle during swing [ Time Frame: 6 months post-op ]
  • Knee flexion angle during swing [ Time Frame: 12 months post-op ]
  • Knee flexion angle during stance [ Time Frame: pre-op ]
  • Knee flexion angle during stance [ Time Frame: 6 months post-op ]
  • Knee flexion angle during stance [ Time Frame: 12 months post-op ]
  • Knee adduction angle during stance [ Time Frame: pre-op ]
  • Knee adduction angle during stance [ Time Frame: 6 months post-op ]
  • Knee adduction angle during stance [ Time Frame: 12 months post-op ]
  • Knee flexion moment [ Time Frame: pre-op ]
  • Knee flexion moment [ Time Frame: 6 months post-op ]
  • Knee flexion moment [ Time Frame: 12 months post-op ]
  • Knee adduction moment [ Time Frame: Pre-op ]
  • Knee adduction moment [ Time Frame: 6 months post-op ]
  • Knee adduction moment [ Time Frame: 12 months post-op ]
  • Knee power [ Time Frame: Pre-op ]
  • Knee power [ Time Frame: 6 month post-op ]
  • Knee power [ Time Frame: 12 month post-op ]
  • Vertical GRF [ Time Frame: pre-op ]
  • Vertical GRF [ Time Frame: 6 months post-op ]
  • Vertical GRF [ Time Frame: 12 month post-op ]
  • AP GRF [ Time Frame: Pre-op ]
  • AP GRF [ Time Frame: 6 months post-op ]
  • AP GRF [ Time Frame: 12 months post-op ]
  • ML GRF [ Time Frame: pre-op ]
  • ML GRF [ Time Frame: 6 months post-op ]
  • ML GRF [ Time Frame: 12 months post-op ]

Central Contacts and Locations

Locations

MORE Foundation

Recruiting

Phoenix, Arizona, United States, 85023

Contacts

More Information

Sponsor

More Foundation

Last update posted

May 6, 2022

Last verified

May, 2022

Keywords

  • Knee osteoarthritis
  • Total knee arthroplasty
  • Lateral pivot

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by More Foundation on 2022-05-06.