Stereo Radiography of TKA Patella Mechanics

NCT02532933 | Completed Results

• 1 other identifier: 779383 2015 Attune Patella
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall purpose is to compare the kinematics and mechanics of medialized dome and anatomic resurfacing through measurement and simulation, and to correlate these findings with patient satisfaction and performance. Aim 1: Comparison of patellofemoral kinematics between dome and anatomic implant designs using stereo radiography and correlation with patient function as measured by Knee injury and Osteoarthritis Outcome score, Knee Society score, and strength. Hypothesis: the anatomic patellar implant will have significantly greater sagittal flexion than the dome implant. Aim 2: Comparison of dome and anatomic moment arm, quadriceps efficiency, patellar contact mechanics and loading through the use of subject-specific simulation. Hypothesis: quadriceps efficiency and moment arm will be greater for the anatomic patellar implant, while loading between the patellar and femoral components will be reduced.

Conditions

Total Knee Arthroplasty

Keywords

Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Patellar Flexion Measured as the Relative Angle Between the Femoral and Patellar Components of the Implant.

  Difference between dome and anatomic patellofemoral flexion, which is measured as the relative angle between the femoral and patellar components of the implant.

  One day

Study Arms (2)

Medialized Dome Patella

ACTIVE COMPARATOR

Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with a medialized dome component geometry

Device: DePuy Synthes Attune PS RP

Anatomic Patella

ACTIVE COMPARATOR

Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with an anatomic component geometry

Device: DePuy Synthes Attune PS RP

Interventions

DePuy Synthes Attune PS RP DEVICE

Anatomic Patella; Medialized Dome Patella

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and Women Age: 18-80 years
• Unilateral or bilateral total knee replacement with an Attune posterior-stabilized rotating-platform implant including either medialized dome or medialized anatomic patellae
• Minimum 9 months post TKA procedure

You may not qualify if:

• Concomitant lower extremity injury that continues to cause pain or loss of normal function (70 or greater Knee Society score)
• Inactive or unable to participate for health reasons (40 or greater on the physical component scale and and the mental component scale composite scores of the SF-12 Health Survey)
• Neurologic deficit that affects function or understanding of testing protocol
• Pregnant
• Other participation in a research study involving exposure to x-ray radiation
• body mass index greater than 30

Sponsors & Collaborators

• University of Denver: lead
• DePuy Synthes: collaborator
• Colorado Joint Replacement: collaborator

Related Links

• Website of the Center for Orthopaedic Biomechanics

Results Point of Contact

• Title: Kevin Shelburne
• Organization: University Of Denver

kevin.shelburne@du.edu

3039021249

Study Officials

• Kevin Shelburne, PhD

  University of Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Engineer

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 26, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11