In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty

The University of Tennessee, Knoxville

Status: Completed

Conditions: Knee Prosthesis

Treatments: Device: Zimmer PCR TKA; Device: Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01864434

130180/2012017

R011373454 (Other Grant/Funding Number)

Details and patient eligibility

About

This study will compare the kinematics data collected from patients with implants created by different manufacturers to see which of these implants provides a more normal-like kinematic pattern compared to the normal knee.

Full description

A better understanding of knee joint kinematics is important to explain premature polyethylene wear failures within knee implants and to help design a prosthesis that most closely approximates the normal knee. Therefore, the objectives for this study are to compare the in vivo kinematic patterns for subjects implanted with either a Stryker Triathlon Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) or Zimmer NexGen PCR TKA design to determine if there are any kinematic differences between these TKA designs. Each subject will be asked to undergo a fluoroscopic evaluation while performing weight-bearing activities under surveillance using the University of Tennessee's new mobile tracking fluoroscopic unit while performing deep knee bend and ramp up and ramp down activities. The mobile fluoroscopy unit is approved for use by the State of Tennessee on a study-by-study basis after IRB approval is obtained for each study.

Enrollment: 50 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be at least 3 months post-operative with no other surgical procedures conducted within the past 6 months
• Must have body weight of less than 250 lbs
• Must have Body Mass Index of less than 38
• Must be judged clinically successful with a Knee Society Score >90
• Must have 100% post-operative passive flexion with no ligamentous laxity or pain
• Must be able to walk on level ground without aid of any kind
• Must be able to ascend and descend a ramp with a 10 degree incline with no assistance
• Must be willing to sign both Informed Consent and HIPAA forms
• Must be between 160 cm (5'3) and 193 cm (6'4) tall

Exclusion criteria

• Pregnant or potentially pregnant females
• Unwilling to sign Informed Consent or HIPAA forms

Trial design

50 participants in 2 patient groups

Patients with a Stryker Triathlon CR TKA

Description:

Patients implanted with a Stryker Triathlon Posterior Cruciate Retaining Total Knee Arthroplasty.

Treatment:

Device: Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)

Patients with a Zimmer PCR TKA

Description:

Patients implanted with a Zimmer NexGen Posterior Cruciate Retaining Total Knee Arthroplasty.

Treatment:

Device: Zimmer PCR TKA