RECRUITING

Gait Analysis of a Lateral-Pivot Design Total Knee Replacement

Conditions

Knee Osteoarthritis Total knee arthroplasty Lateral pivot

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Gait Analysis of a Lateral-Pivot Design Total Knee Replacement

Quick Facts

Study Start:2017-02-02

Study Completion:2029-01-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04275362

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. At least 50 years of age. 2. Subjects who provide signed and IRB approved informed consent for gait analysis data collection 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. 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.	1. Controls with any musculoskeletal injury or disorder. 2. Controls that are pregnant or planning on becoming pregnant. 3. Controls with a BMI\>40 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. 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.

Inclusion Criteria

Exclusion Criteria

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

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

Contacts and Locations

Study Contact

John D McCamley, PhD

CONTACT

623.241.5472

john.mccamley@more-foundation.org

Debra Sietsema, PhD

CONTACT

623.455.7109

debra.sietsema@more-foundation.org

Principal Investigator

Scott Siverhus, MD

PRINCIPAL_INVESTIGATOR

The CORE Institute

Study Locations (Sites)

MORE Foundation

Phoenix, Arizona, 85023

United States

Collaborators and Investigators

Sponsor: More Foundation

Scott Siverhus, MD, PRINCIPAL_INVESTIGATOR, The CORE Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-02-02

Study Completion Date2029-01-02

Study Record Updates

Study Start Date2017-02-02

Study Completion Date2029-01-02

Terms related to this study

Keywords Provided by Researchers

Knee osteoarthritis
Total knee arthroplasty
Lateral pivot

Additional Relevant MeSH Terms

Knee Osteoarthritis