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Analysis of Competitive Posterior Cruciate Retaining (PCR) and Posterior Stabilized (PS) Total Knee Arthroplasty (TKA)

NCT ID: NCT04321356

Last Updated: 2023-11-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-24

Study Completion Date

2022-05-16

Brief Summary

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The purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who were implanted with Stryker Posterior Cruciate Retaining (PCR) , Stryker Posterior Stabilized (PS), Zimmer PCR, and Zimmer PS Total Knee Arthroplasty (TKAs). Our lab has previously collected data for the Smith \& Nephew PCR, bi-cruciate retaining (BCR), and bi-cruciate stabilized (BCS) TKA.

Detailed Description

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The objective for this study is to analyze the in vivo kinematics for subjects implanted with either a Stryker PCR, Stryker PS, Zimmer PCR, and Zimmer PS TKA and to compare those patterns to subjects having a normal knee from our previous study and to those patterns from subjects having a Smith \& Nephew PCR, BCR, and BCS TKA.

Conditions

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Knee Osteoarthritis Total Knee Arthroplasty Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Stryker Triathlon PCR TKA

Subjects implanted with a Stryker Triathlon PCR TKA

Triathlon PCR TKA

Intervention Type DEVICE

Total Knee Arthroplasty System

Stryker Triathlon PS TKA

Subjects implanted with a Stryker Triathlon PS TKA

Triathlon PS TKA

Intervention Type DEVICE

Total Knee Arthroplasty System

Zimmer Persona PCR TKA

Subjects implanted with a Zimmer Persona PCR TKA

Persona PCR TKA

Intervention Type DEVICE

Total Knee Arthroplasty System

Zimmer Persona PS TKA

Subjects implanted with a Zimmer Persona PS TKA

Persona PS TKA

Intervention Type DEVICE

Total Knee Arthroplasty System

Interventions

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Triathlon PCR TKA

Total Knee Arthroplasty System

Intervention Type DEVICE

Triathlon PS TKA

Total Knee Arthroplasty System

Intervention Type DEVICE

Persona PCR TKA

Total Knee Arthroplasty System

Intervention Type DEVICE

Persona PS TKA

Total Knee Arthroplasty System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subjects will have one of the following implant types: 1) Stryker Triathlon PCR TKA (28 subjects), 2) Stryker Triathlon PS TKA (28 subjects), 3) Zimmer Persona PCR TKA (28 subjects) and 4) Zimmer Persona PS TKA (28 subjects).
2. Patients must be at least three months post-operative.
3. Participants must not experience any pain or other post-operative complications.
4. Participants must have a stable TKA and be capable of performing a deep knee bend activity.
5. Participants must weigh less than 300 lbs., not underweight (BMI \< 18.5) or too obese (BMI\>35).
6. Must be in the age range of 18 years to 85 years (both inclusive).
7. Participants must be able to perform the required activities without concern.
8. Subjects must be willing to sign the Informed Consent (IC) form to participate in the study.
9. Patients who do not have previous surgery on the implanted knee that might restrict their movement.

Exclusion Criteria

1. Pregnant, potentially pregnant, lactating females or of childbearing age. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study. (All potential female study patients will be asked if they are premenopausal or if they have undergone a hysterectomy. If the possibility of pregnancy exists, a pregnancy kit will be given to the patient at the informed consent meeting, just prior to the fluoro. Results of the test will be recorded in a test log. Any female patient showing a positive test will be excluded from testing.)
2. Subjects without the required type of knee implant.
3. Cannot have pain in other parts of the body that would prohibit the subject from performing the activities).
4. Cannot have ligamentous pain and/or laxity.
5. Unwilling to sign IC/HIPAA form(s).
6. Does not speak English.
7. Patients who have enrolled in a fluoroscopic kinematic study within the past year.
8. Patients currently involved in any personal injury litigation, medical/legal or worker's compensation claims.
9. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
10. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Smith & Nephew, Inc.

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 Komistek, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Tennessee

Locations

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Tennessee Orthopaedic Clinic

Knoxville, Tennessee, United States

Site Status

The University of Tennessee

Knoxville, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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3187FB WIRB20180745 Extension

Identifier Type: -

Identifier Source: org_study_id