Gait analysis of a new knee replacement design

Gait Analysis of a Lateral-Pivot Design Total Knee Replacement

This study is testing how well people walk after getting a new type of knee replacement to see how it compares to other knee replacements and healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 102 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: More Foundation (Academic / other)
• Locations: 1 site (Phoenix, Arizona)
• Trial ID: NCT04275362 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze the gait of patients receiving the DJO Global Empowr PS Knee System, a single-radius lateral pivot design for total knee replacement. It will compare the gait performance of these patients with age-matched controls and previously collected data from patients who received other knee replacement systems. The study will utilize a motion analysis laboratory to gather detailed gait data, including kinetic, kinematic, and electromyographic measurements. Patients will undergo standardized rehabilitation protocols to ensure consistency in recovery outcomes.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 50 and older who are scheduled to receive the DJO Global Empowr PS total knee replacement.

Not a fit: Patients with musculoskeletal injuries or disorders other than knee osteoarthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved knee function and patient satisfaction following total knee replacement surgery.

How similar studies have performed: Previous studies have shown that different knee replacement designs can significantly impact gait performance, suggesting that this approach may yield valuable insights.

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.

Where this trial is running

Phoenix, Arizona

• MORE Foundation — Phoenix, Arizona, United States (Recruiting)

Study contacts

• Principal investigator: Scott Siverhus, MD — The CORE Institute
• Study coordinator: John D McCamley, PhD

Conditions Knee Osteoarthritis; Knee osteoarthritis; Total knee arthroplasty; Lateral pivot