Journey 2 Multi Center Kinematic Study

NCT ID: NCT05107414

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-15

Study Completion Date

2024-12-15

Brief Summary

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The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs.

Detailed Description

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Conditions

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Total Knee Arthroplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Journey II Bi-Cruciate Stabilized

Participants who have been implanted with a Smith \& Nephew Journey II BCS TKA

Total Knee Arthroplasty

Intervention Type PROCEDURE

Participants have previously undergone a total knee replacement surgery.

Journey II Cruciate Retaining

Participants who have been implanted with a Smith \& Nephew Journey II CR TKA

Total Knee Arthroplasty

Intervention Type PROCEDURE

Participants have previously undergone a total knee replacement surgery.

Journey II Bi-Cruciate Retaining

Participants who have been implanted with a Smith \& Nephew Journey II BCR TKA

Total Knee Arthroplasty

Intervention Type PROCEDURE

Participants have previously undergone a total knee replacement surgery.

Interventions

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Total Knee Arthroplasty

Participants have previously undergone a total knee replacement surgery.

Intervention Type PROCEDURE

Other Intervention Names

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Smith & Nephew Journey II TKA

Eligibility Criteria

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Inclusion Criteria

1. Patients in the age range of 18 years to 85 years (both inclusive)
2. Patients who have a BMI less than 35
3. Patients who do not have previous surgery on the implanted knee that might restrict their movement
4. Patient who are at least 6 months post-operative
5. Patients who do not experience any pain or other post-operative complications
6. Patients who have a stable TKA and can perform a deep knee bend activity
7. Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms
8. Subjects will have a Journey II knee system

Exclusion Criteria

1. Pregnant, potentially pregnant, or lactating females. 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.
2. Patients who have currently enrolled in a fluoroscopic study within the past year.
3. Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims.
4. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
5. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability
6. Subjects who are unable to perform a deep knee bend.
7. Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
8. Subjects without the required type of knee implant.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Tennessee, Knoxville

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Tennessee

Knoxville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael LaCour, PhD

Role: CONTACT

(865) 974-2093

Richard Komistek, PhD

Role: CONTACT

Facility Contacts

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Michael LaCour, PhD

Role: primary

865-974-2093

Other Identifiers

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20203268

Identifier Type: -

Identifier Source: org_study_id

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