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NCT Number: NCT04275362

Gait Analysis of a Lateral-Pivot Design Total Knee Replacement

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Thirty subjects who are scheduled to receive an Empowr PS Total Knee Replacement device will be consented to be in the prospective component of the study. Twenty of these patients will participate in motion data collection. These patients will all be scheduled to undergo primary total knee replacement using the Empowr device. All surgeries will be performed using computer navigation. Patients will receive standardized physical therapy to insure consistency of rehab protocols and discharge from physical therapy criteria. Specifically, patients will be monitored for visit compliance, Timed Up and Go (TUG) test in seconds, AROM in degrees, and walking un-aided.

Data were previously collected preoperatively, at 6 months and 1 year post-operatively for 16 patients who received a Stryker Triathlon total knee replacement and preoperatively and 1 year post-op for 16 patients who received a Biomet Vanguard total knee replacement. Data were also previously collected for 20 age matched healthy controls subjects. Data will be collected for an additional 20 control subjects. Knee Society Score (KSS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) will be collected at pre-op, 6 months, 1 year, and 2 years post-op. Gait analysis data will include kinetic, kinematic, temporal spatial, and electromyographic (EMG) data throughout the gait cycle for both research subjects and controls. Reflective markers will be placed on subject's anatomical landmarks, and ten surface EMG electrodes placed according to published standards (8). Subjects will walk at a self-selected speed down a runway embedded with force plates while 10 Eagle-4 digital infrared cameras record their movement. In addition to the level surface walking, additional data on more complex activities of daily living will be collected for potential future analysis. This would include: sit-to-stand, balance, and stair-climbing measurements also using the force plates, camera system and EMG data collection.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DJO Empowr PS Knee System

Device

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

Stryker Triathlon Total Knee System

Device

Patients received a Stryker Triathlon Total Knee System total knee replacement

Biomet Vanguard Complete Knee System

Device

Patients received a Biomet Vanguard Complete Knee System total knee replacement

Control

Device

No total knee replacement

Primary outcomes

  1. Knee flexion angle during swing

    Time frame: Pre-op

    Compare maximum knee flexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  2. Knee flexion angle during swing

    Time frame: 6 months post-op

    Compare maximum knee flexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  3. Knee flexion angle during swing

    Time frame: 12 months post-op

    Compare maximum knee flexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  4. Knee flexion angle during stance

    Time frame: pre-op

    Compare maximum knee flexion angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  5. Knee flexion angle during stance

    Time frame: 6 months post-op

    Compare maximum knee flexion angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  6. Knee flexion angle during stance

    Time frame: 12 months post-op

    Compare maximum knee flexion angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  7. Knee adduction angle during stance

    Time frame: pre-op

    Compare maximum knee adduction angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  8. Knee adduction angle during stance

    Time frame: 6 months post-op

    Compare maximum knee adduction angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  9. Knee adduction angle during stance

    Time frame: 12 months post-op

    Compare maximum knee adduction angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.knee replacement (DJO Empowr) and single-radius (Triathlon, Stryker) and multi-radius (Vanguard, Zimmer Biomet) knee replacements.

  10. Knee flexion moment

    Time frame: pre-op

    Compare maximum knee flexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  11. Knee flexion moment

    Time frame: 6 months post-op

    Compare maximum knee flexion moment normalised to subject body weight (N-m/kg) during stance between between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  12. Knee flexion moment

    Time frame: 12 months post-op

    Compare maximum knee flexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  13. Knee adduction moment

    Time frame: Pre-op

    Compare maximum knee adduction moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  14. Knee adduction moment

    Time frame: 6 months post-op

    Compare maximum knee adduction moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), oe a single-radius (Triathlon, Stryker) knee replacement.

  15. Knee adduction moment

    Time frame: 12 months post-op

    Compare maximum knee adduction moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  16. Knee power

    Time frame: Pre-op

    Compare maximum knee power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  17. Knee power

    Time frame: 6 month post-op

    Compare maximum knee power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  18. Knee power

    Time frame: 12 month post-op

    Compare maximum knee power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  19. Vertical GRF

    Time frame: pre-op

    Compare maximum vertical ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  20. Vertical GRF

    Time frame: 6 months post-op

    Compare maximum vertical ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  21. Vertical GRF

    Time frame: 12 month post-op

    Compare maximum vertical ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  22. AP GRF

    Time frame: Pre-op

    Compare maximum anterior-posterior ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  23. AP GRF

    Time frame: 6 months post-op

    Compare maximum anterior-posterior ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  24. AP GRF

    Time frame: 12 months post-op

    Compare maximum anterior-posterior ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  25. ML GRF

    Time frame: pre-op

    Compare maximum medial-lateral ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  26. ML GRF

    Time frame: 6 months post-op

    Compare maximum anterior-posterior ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  27. ML GRF

    Time frame: 12 months post-op

    Compare maximum anterior-posterior ground reaction force normalised to subject body weight (unitless) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

Secondary outcomes

  1. Ankle dorsiflexion angle during swing

    Time frame: Pre-op

    Compare maximum ankle dorsiflexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  2. Ankle dorsiflexion angle during swing

    Time frame: 6 months post-op

    Compare maximum ankle dorsiflexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  3. Ankle dorsiflexion angle during swing

    Time frame: 12 months post-op

    Compare maximum ankle dorsiflexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  4. Ankle plantarflexion angle during stance

    Time frame: pre-op

    Compare maximum ankle plantarflexion angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  5. Ankle plantarflexion angle during stance

    Time frame: 6 months post-op

    Compare maximum ankle plantarflexion angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  6. Ankle plantarflexion angle during stance

    Time frame: 12 months post-op

    Compare maximum ankle plantarflexion angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  7. Ankle plantarflexion moment during stance

    Time frame: pre-op

    Compare maximum ankle plantarflexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  8. Ankle plantarflexion moment during stance

    Time frame: 6 months post-op

    Compare maximum ankle plantarflexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  9. Ankle plantarflexion moment during stance

    Time frame: 12 months post-op

    Compare maximum ankle plantarflexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  10. Ankle power

    Time frame: Pre-op

    Compare maximum ankle power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  11. Ankle power

    Time frame: 6 months post-op

    Compare maximum ankle power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  12. Ankle power

    Time frame: 12 months post-op

    Compare maximum ankle power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  13. Hip flexion maximum during swing

    Time frame: Pre-op

    Compare hip flexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  14. Hip flexion during swing

    Time frame: 6 months post-op

    Compare maximum hip flexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  15. Hip flexion during swing

    Time frame: 12 months post-op

    Compare maximum hip flexion angle in degrees during swing between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  16. Hip extension during stance

    Time frame: Pre-op

    Compare maximum hip extension angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  17. Hip extension during stance

    Time frame: 6 months post-op

    Compare maximum hip extension angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  18. Hip extension during stance

    Time frame: 12 months post-op

    Compare maximum hip extension angle in degrees during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  19. Hip flexion moment during stance

    Time frame: Pre-op

    Compare maximum hip flexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  20. Hip flexion moment during stance

    Time frame: 6 months post-op

    Compare maximum hip flexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  21. Hip flexion moment during stance

    Time frame: 12 months post-op

    Compare maximum hip flexion moment normalised to subject body weight (N-m/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  22. Hip power

    Time frame: Pre-op

    Compare maximum hip power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  23. Hip power

    Time frame: 6 months post-op

    Compare maximum hip power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  24. Hip power

    Time frame: 12 months post-op

    Compare maximum hip power in the sagittal plane normalised to subject body weight (W/kg) during stance between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  25. KSS

    Time frame: Pre-op

    Compare Knee Society Score between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  26. KSS

    Time frame: 6 months post-op

    Compare Knee Society Score between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  27. KSS

    Time frame: 12 months post-op

    Compare Knee Society Score between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  28. LEAS

    Time frame: Pre-op

    Compare Lower Extremity Activity Score between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

  29. LEAS

    Time frame: 6 months post-op

    Compare Lower Extremity Activity Score between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), or a single-radius (Triathlon, Stryker) knee replacement.

  30. LEAS

    Time frame: 12 months post-op

    Compare Lower Extremity Activity Score between healthy controls, and subjects with a dual pivot design total knee replacement (DJO Empowr), a single-radius (Triathlon, Stryker) knee replacement or a multi-radius (Vanguard, Zimmer Biomet) knee replacement.

Study contacts

Contact information is provided by the study sponsor or research team.

Debra Sietsema, PhD

CONTACT

[email protected]

623.455.7109

John D McCamley, PhD

CONTACT

[email protected]

623.241.5472

Sponsors and collaborators

Lead sponsor

More Foundation

Other

Collaborators

  • Encore Medical, L.P.

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2029
First posted
Feb 19, 2020
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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