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Gait Analysis of a Lateral-Pivot Design Total Knee Replacement

RecruitingObservational studyHealthy volunteers welcome

Who can join

Ages 50 and older · All sexes · Healthy volunteers welcome

Full eligibility criteria
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.

About the 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.

What is being tested

Sponsor: More Foundation · Participants: 102 · Started: Feb 2, 2017

Contact the study team

Official record on ClinicalTrials.gov — NCT04275362

Locations in the U.S.

ArizonaMORE Foundation, Phoenix

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.