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Gait Analysis of a Lateral-Pivot Design Total Knee Replacement

More Foundation · with Encore Medical, L.P. · NCT04275362

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 50+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
102
US sites recruiting
1
Study start
February 2, 2017
Record last updated
May 6, 2022

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: DJO Empowr PS Knee System; Stryker Triathlon Total Knee System; Biomet Vanguard Complete Knee System; Control

Conditions: Knee Osteoarthritis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • MORE Foundation

    Phoenix, AZ 85023

    Site contact: John D McCamley, PhD · 623-241-8721 · john.mccamley@more-foundation.org

Study contacts (from the official record)

  • John D McCamley, PhD · 623.241.5472 · john.mccamley@more-foundation.org
  • Debra Sietsema, PhD · 623.455.7109 · debra.sietsema@more-foundation.org
All arthritis studies in Arizona →
Gait Analysis of a Lateral-Pivot Design Total Knee Replacement (NCT04275362) | Bored Studies