In Vivo Kinematics for Subjects With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA
NCT ID: NCT04612036
Last Updated: 2023-11-29
Study Results
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View full resultsBasic Information
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COMPLETED
60 participants
OBSERVATIONAL
2020-10-22
2022-05-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Journey II Bi-Cruciate Stabilized
Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected
Journey II Bi-Cruciate Stabilized TKA
Total Knee Arthroplasty System
Journey II Cruciate Retaining
Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained)
Journey II Cruciate Retaining TKA
Total Knee Arthroplasty System
Journey II Bi-Cruciate Retaining
Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained
Journey II Bi-Cruciate Retaining TKA
Total Knee Arthroplasty System
Interventions
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Journey II Bi-Cruciate Stabilized TKA
Total Knee Arthroplasty System
Journey II Cruciate Retaining TKA
Total Knee Arthroplasty System
Journey II Bi-Cruciate Retaining TKA
Total Knee Arthroplasty System
Eligibility Criteria
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Inclusion Criteria
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, either the BCS or XR, knee system
Exclusion Criteria
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.
18 Years
85 Years
ALL
No
Sponsors
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The University of Tennessee, Knoxville
OTHER
Responsible Party
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Principal Investigators
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Michael LaCour, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Tennessee
Locations
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The University of Tennessee
Knoxville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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WIRB20203268
Identifier Type: -
Identifier Source: org_study_id