In Vivo Determination of 3D Patellofemoral Mechanics

NCT ID: NCT01290627

Last Updated: 2019-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-09-30

Brief Summary

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This study will analyze the tibio-femoral and patellofemoral (motion) and mechanics (forces) of participants having a normal knee or a total knee arthroplasty (TKA) using one or two different (TKA) devices Low Contract Stress (LCS) Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA). All knees will be analyzed using an image matching technique that will convert a two-dimensional (2D) fluoroscopic image into a three-dimensional (3D) image. In conjunction with the fluoroscopic analysis, electromyography (EMG) data, and ground reaction force (GRF) data will all be allow for a complete analysis of the knee joints. These results will help the orthopaedic community better understand knee motion so they can improve testing on existing implants and develop future implants that will further enhance patients' lives.

Detailed Description

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Conditions

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Arthroplasty Replacement Knee Knee Prosthesis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Knee Prosthesis LCS PS RP TKA

Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)

Subjects implanted with DePuy LCS PS RP TKA

Intervention Type DEVICE

Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)

Knee Prosthesis Sigma PS RP TKA

Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)

Subjects implanted with DePuy Sigma PS RP TKA

Intervention Type DEVICE

Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)

Control

Subjects with normal knees

No interventions assigned to this group

Interventions

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Subjects implanted with DePuy LCS PS RP TKA

Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)

Intervention Type DEVICE

Subjects implanted with DePuy Sigma PS RP TKA

Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients must be at least six months post-operative.
2. Potential subjects will have a body weight of less than 250 lbs.
3. Candidates must have an AKS score \>70 post-operatively.
4. Patients must have passive flexion of at least 100.
5. Implanted group must have either an LCS PS RP TKA, having an anatomical patella, or Sigma PS RP TKA; or normal knee group must have normal knee.
6. Must be willing to sign both Informed Consent and HIPAA forms.

Exclusion Criteria

1. Pregnant females.
2. Subjects not meeting study requirements.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DePuy Orthopaedics

INDUSTRY

Sponsor Role collaborator

The University of Tennessee, Knoxville

OTHER

Sponsor Role lead

Responsible Party

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Richard Komistek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard D. Komistek, Ph D

Role: PRINCIPAL_INVESTIGATOR

The University of Tennessee

Douglas Dennis, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Joint Replacement, Porter Adventist Hosp

Locations

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Colorado Joint Replacement

Denver, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Perkins Hall

Knoxville, Tennessee, United States

Site Status

Science and Engineering Research Facility

Knoxville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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R011373372

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

10035/IIS-000126

Identifier Type: -

Identifier Source: org_study_id

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