Comparison of TKAs Using Force Plate Analysis

Comparison of Different TKAs Using Objective Dynamic Functional Analysis

The purpose of this study is to evaluate performance of two modern total knee arthroplasty designs using patient reported outcomes and force exhibited during various activities of daily living.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Knee Injuries; Knee Arthritis; Total Knee Arthroplasty
• Intervention / Treatment: Device: Depuy Synthes ATTUNE PCR TKA; Device: MicroPort Orthopedics EVOLUTION Medial Pivot TKA

Detailed Description

48 patients with primary osteoarthritis of the knee who have been appropriately designated for treatment with a total knee arthroplasty (TKA) will be randomly assigned to one of two groups; one group (24 patients) will receive a Depuy Attune PCR knee implant, and one group (24 patients) will receive a MicroPort Orthopedics Evolution Medial Pivot knee implant utilizing standard and modern techniques. These two implants are designed to recreate the kinematic motion of a native knee articulation using different biomechanical design philosophies.

The patients will be monitored post-operatively using subjective and objective measures. Subjective patient reported outcomes will be analyzed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), recorded preoperatively, as well as at 6 weeks, and 3 months postoperatively. Objective outcomes will be measured by having the patients perform four activities over force plates that will measure the amount of force a patient generates. The four activities will be: walking, standing from a seated position in a chair, squatting to a seated position, and walking up stairs. These objective measures will also be recorded preoperatively, 6 weeks, and 3 months postoperatively. The patient reported outcomes and the objective measures will then be compared between the two groups.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Russell Nevins, MD; Phone Number: 702-731-1616; Email: russellnevinsmd@gmail.com
• Study Contact Backup: Name: Kevin Sagers; Phone Number: 702-538-6929; Email: kevsagers11@gmail.com

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • Recruiting
      • Desert Orthopaedic Center
      • Contact: Russell Nevins, MD; Phone Number: 702-731-1616; Email: russellnevinsmd@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who have been appropriately designated for treatment with a primary total knee arthroplasty
• Subjects who are willing to participate and are willing to sign the Informed Consent/HIPPA documents.

Exclusion Criteria:

• Subjects who are unsuitable candidates for the two types of knee implants under investigation.
• Subjects with significant deformities or arthritis that might affect the procedural decision making, expected outcomes and functions are total knee arthroplasty.
• Subjects with significant comorbidities that might be at an increased risk of post-operative complications.
• Subjects who are unwilling to sign Informed Consent/HIPAA documents.
• Subjects who cannot perform the required activities after the surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Depuy Attune; Subjects will have been implanted with the Depuy Attune PCR TKA	Device: Depuy Synthes ATTUNE PCR TKA; Subjects will have been implanted with the Depuy Attune PCR TKA
ACTIVE_COMPARATOR: MicroPort Medial Pivot; Subjects will have been implanted with the Microport Evolution Medial Pivot TKA	Device: MicroPort Orthopedics EVOLUTION Medial Pivot TKA; Subjects will have been implanted with the Microport Evolution Medial Pivot TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score	KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms	pre-operatively
Knee Injury and Osteoarthritis Outcome Score	KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms	6 weeks post-operatively
Knee Injury and Osteoarthritis Outcome Score	KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms	3 months post-operatively
Force generated by operative extremity - walking	Distribution of maximum force between implanted and non- implanted leg during walking	pre-operatively
Force generated by operative extremity - walking	Distribution of maximum force between implanted and non- implanted leg during walking	6 weeks post-operatively
Force generated by operative extremity - walking	Distribution of maximum force between implanted and non- implanted leg during walking	3 months post-operatively
Force generated by operative extremity - standing from seated position	Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair	pre-operatively
Force generated by operative extremity - standing from seated position	Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair	6 weeks post-operatively
Force generated by operative extremity - standing from seated position	Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair	3 months post-operatively
Force generated by operative extremity - squatting to a seated position	Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position	pre-operatively
Force generated by operative extremity - squatting to a seated position	Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position	6 weeks post-operatively
Force generated by operative extremity - squatting to a seated position	Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position	3 months post-operatively
Force generated by operative extremity - walking up stairs	Distribution of maximum force between implanted and non- implanted leg during walking up stairs	pre-operatively
Force generated by operative extremity - walking up stairs	Distribution of maximum force between implanted and non- implanted leg during walking up stairs	6 weeks post-operatively
Force generated by operative extremity - walking up stairs	Distribution of maximum force between implanted and non- implanted leg during walking up stairs	3 months post-operatively

Collaborators and Investigators

• Sponsor: Russell Nevins, M.D.
• Collaborators: MicroPort Orthopedics Inc.
• Investigators: Principal Investigator: Russell Nevins, Desert Orthopedics

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2020
• Primary Completion (ANTICIPATED): November 1, 2021
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (ACTUAL): November 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 31, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Knee Injuries
• Other Study ID Numbers: 17IISK01 0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes