Comparison of TKAs Using Force Plate Analysis

Russell Nevins, M.D.

Status: Unknown

Conditions: Knee Injuries; Knee Arthritis; Knee Osteoarthritis; Total Knee Arthroplasty

Treatments: Device: MicroPort Orthopedics EVOLUTION Medial Pivot TKA; Device: Depuy Synthes ATTUNE PCR TKA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04163445

17IISK01 0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

48 participants in 2 patient groups

Depuy Attune

Active Comparator group

Description:

Subjects will have been implanted with the Depuy Attune PCR TKA

Treatment:

Device: Depuy Synthes ATTUNE PCR TKA

MicroPort Medial Pivot

Active Comparator group

Description:

Subjects will have been implanted with the Microport Evolution Medial Pivot TKA

Treatment:

Device: MicroPort Orthopedics EVOLUTION Medial Pivot TKA