In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty

Knee Prosthesis Clinical Trial

Official title:

In Vivo Comparison of Kinematics for Patients Implanted With Either a Stryker or a Zimmer Posterior Cruciate Retaining Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864434
• Other study ID #: 130180/2012017
• Secondary ID: R011373454
• Status: Completed
• Start date: June 2013
• Est. completion date: November 2014

Study information

• Verified date: October 2019
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Prosthesis

Intervention

Device:
• Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)
The fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.
• Zimmer PCR TKA
The fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinematics - Deep Knee Bend Activity	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	3 months post-operative
Primary	Kinematics - Ramp up Activity	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	3 months post-operative
Primary	Kinematics - Ramp Down Activity	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	3 months post-operative