In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty

NCT01864434 | Completed Results

• 2 other identifiers: 130180/2012017R011373454
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

Knee Prosthesis

Keywords

Knee Prosthesis; Total Knee Arthroplasty; Cruciate Retaining; Posterior Cruciate Retaining

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Patients with a Stryker Triathlon CR TKA

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

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

Patients with a Zimmer PCR TKA

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

Device: Zimmer PCR TKA

Interventions

Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA) DEVICE

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.

Also known as: Triathlon PCR TKA

Patients with a Stryker Triathlon CR TKA

Zimmer PCR TKA DEVICE

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.

Also known as: Zimmer NexGen PCR TKA

Patients with a Zimmer PCR TKA

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• Stryker Orthopaedics: collaborator

Study Sites (4)

Tennessee Orthopaedic Clinic, Tennessee Orthopaedic Foundation for Education & Research

Knoxville, Tennessee, 37923, United States

Location

Dougherty Engineering Building, Room M007

Knoxville, Tennessee, 37996, United States

Location

Perkins Hall, The University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Science and Engineering Research Facility

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Interventions

Polymerase Chain Reaction; Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Adrija Sharma, Ph. D.
• Organization: University of Tennessee

asharma1@utk.edu

8659742093

Study Officials

• Adrija Sharma, Ph D

  The University of Tennessee

  PRINCIPAL INVESTIGATOR

• Richard D Komistek, Ph D

  The University of Tennessee

  PRINCIPAL INVESTIGATOR

• William R Hamel, Ph D

  The University of Tennessee

  PRINCIPAL INVESTIGATOR

• Harold E Cates, MD

  Tennessee Orthopaedic Clinics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 29, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 10, 2019
• Results First Posted: December 24, 2014

Record last verified: 2019-10

Locations

US (4)