Clinical trial NCT01864434: In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty
Official title: In Vivo Comparison of Kinematics for Patients Implanted With Either a Stryker or a Zimmer Posterior Cruciate Retaining Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Prosthesis
Keywords: Knee Prosthesis
Total Knee Arthroplasty
Cruciate Retaining
Posterior Cruciate Retaining
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: Stryker Orthopaedics
First posted: 2013-05-29
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be patients of Dr. Harold E. Cates of Tennessee Orthopaedic Clinics and must have been implanted with either a Stryker Triathlon CR TKA or Zimmer PCR TKA

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.

Eligibility criteria: 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

Primary outcomes:
measure: Kinematics - Deep Knee Bend Activity
timeFrame: 3 months post-operative
measure: Kinematics - Ramp up Activity
timeFrame: 3 months post-operative
measure: Kinematics - Ramp Down Activity
timeFrame: 3 months post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Tennessee Orthopaedic Clinic, Tennessee Orthopaedic Foundation for Education & Research
state: Tennessee
city: Knoxville
country: United States
facility: Dougherty Engineering Building, Room M007
state: Tennessee
city: Knoxville
country: United States
facility: Perkins Hall, The University of Tennessee
state: Tennessee
city: Knoxville
country: United States
facility: Science and Engineering Research Facility
state: Tennessee
Study officials:
affiliation: The University of Tennessee
name: Adrija Sharma, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Tennessee
name: Richard D Komistek, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Tennessee
name: William R Hamel, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Tennessee Orthopaedic Clinics
name: Harold E Cates, MD
role: PRINCIPAL_INVESTIGATOR
References: