Comparison of TKAs Using Force Plate Analysis

Not Applicable

• Conditions: Knee Osteoarthritis; Total Knee Arthroplasty; Knee Injuries; Knee Arthritis
• Interventions: Device: Depuy Synthes ATTUNE PCR TKA; Device: MicroPort Orthopedics EVOLUTION Medial Pivot TKA

• Registration Number: NCT04163445
• Lead Sponsor: Russell Nevins, M.D.

Brief 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.

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 Timeline

• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-14
• Study Start: 2020-11-11
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-31
• Last Update Posted: 2021-08-06
• Primary Completion: 2021-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Depuy Attune	Depuy Synthes ATTUNE PCR TKA	Subjects will have been implanted with the Depuy Attune PCR TKA
MicroPort Medial Pivot	MicroPort Orthopedics EVOLUTION Medial Pivot TKA	Subjects will have been implanted with the Microport Evolution Medial Pivot TKA

Primary Outcome Measures

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

Trial Locations

Locations (1)

Desert Orthopaedic Center; 🇺🇸 Las Vegas, Nevada, United States