Comparison of TKAs Using Force Plate Analysis

Knee Osteoarthritis Clinical Trial

Official title:

Comparison of Different TKAs Using Objective Dynamic Functional Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04163445
• Other study ID #: 17IISK01 0
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2020
• Est. completion date: November 2022

Study information

• Verified date: July 2021
• Source: Desert Orthopedic Center
• Contact: Russell Nevins, MD
• Phone: 702-731-1616
• Email: russellnevinsmd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Arthritis
• Knee Injuries
• Knee Osteoarthritis
• Osteoarthritis, Knee
• Total Knee Arthroplasty

Intervention

Device:
• MicroPort Orthopedics EVOLUTION Medial Pivot TKA
Subjects will have been implanted with the Microport Evolution Medial Pivot TKA
• Depuy Synthes ATTUNE PCR TKA
Subjects will have been implanted with the Depuy Attune PCR TKA

Locations

Country	Name	City	State
United States	Desert Orthopaedic Center	Las Vegas	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
Russell Nevins, M.D.	MicroPort Orthopedics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Force generated by operative extremity - walking	Distribution of maximum force between implanted and non- implanted leg during walking	pre-operatively
Primary	Force generated by operative extremity - walking	Distribution of maximum force between implanted and non- implanted leg during walking	6 weeks post-operatively
Primary	Force generated by operative extremity - walking	Distribution of maximum force between implanted and non- implanted leg during walking	3 months post-operatively
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Force generated by operative extremity - walking up stairs	Distribution of maximum force between implanted and non- implanted leg during walking up stairs	pre-operatively
Primary	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
Primary	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