In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty
- Conditions
- Knee Prosthesis
- Interventions
- Device: Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)Device: Zimmer PCR TKA
- Registration Number
- NCT01864434
- Lead Sponsor
- The University of Tennessee, Knoxville
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- Pregnant or potentially pregnant females
- Unwilling to sign Informed Consent or HIPAA forms
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with a Stryker Triathlon CR TKA Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA) Patients implanted with a Stryker Triathlon Posterior Cruciate Retaining Total Knee Arthroplasty. Patients with a Zimmer PCR TKA Zimmer PCR TKA Patients implanted with a Zimmer NexGen Posterior Cruciate Retaining Total Knee Arthroplasty.
- Primary Outcome Measures
Name Time Method Kinematics - Ramp up Activity 3 months post-operative Lateral Anterior Posterior (LAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] and Medial Anterior Posterior (MAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] translations, and Axial Rotation (AR) \[during 3 moments - 0-33%, 33-66% and 66-100%\] of medial femoral condyles during ramp up activity
Kinematics - Deep Knee Bend Activity 3 months post-operative Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity
Kinematics - Ramp Down Activity 3 months post-operative Lateral Anterior Posterior (LAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] and Medial Anterior Posterior (MAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] translations, and Axial Rotation (AR) \[during 3 moments - 0-33%, 33-66% and 66-100%\] of medial femoral condyles during ramp down activity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Dougherty Engineering Building, Room M007
🇺🇸Knoxville, Tennessee, United States
Perkins Hall, The University of Tennessee
🇺🇸Knoxville, Tennessee, United States
Science and Engineering Research Facility
🇺🇸Knoxville, Tennessee, United States
Tennessee Orthopaedic Clinic, Tennessee Orthopaedic Foundation for Education & Research
🇺🇸Knoxville, Tennessee, United States