Kinematics in Posterior Cruciate Retaining and Bi-Cruciate Retaining Total Knee Replacements

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-11-09

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 the Smith \& Nephew Journey II posterior cruciate retaining (PCR) total knee arthroplasty (TKA) or Journey II bi-cruciate retaining (BCR) TKA. CMR has previously collected data for the Smith \& Nephew BCS TKA and compared these kinematics data to those of normal knees.

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Detailed Description

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

Conditions

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Arthroplasty, Replacement, Knee Osteoarthritis, Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Smith & Nephew Journey II PCR TKA

Subjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty

Journey II posterior cruciate retaining total knee arthroplasty

Intervention Type DEVICE

Smith & Nephew Journey II BCR TKA

Subjects implanted with a Smith \& Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty

Journey II posterior bi-cruciate retaining total knee arthroplasty

Intervention Type DEVICE

Interventions

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Journey II posterior cruciate retaining total knee arthroplasty

Intervention Type DEVICE

Journey II posterior bi-cruciate retaining total knee arthroplasty

Intervention Type DEVICE

Other Intervention Names

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Journey II PCR TKA Journey II BCR TKA

Eligibility Criteria

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Inclusion Criteria

* Must have must either a Smith \& Nephew Journey II PCR or BCR TKA
* Must be at least three months post-operative
* Must have a Knee Society score of \>90 with no ligamentous laxity or pain
* Weigh 250 pounds or less
* Should have good-to-excellent post-operative flexion
* Must be able to perform activities (without aid of any kind) and without pain, walking up and down a ramp, performing a deep knee bend and rising from that kneeling position after the deep knee bend
* Must not have had other surgical procedures conducted within the past six months that will prohibit them from performing the study activities
* Must have body mass index (BMI) of less than 38
* Must be between 40-85 years of age
* Must be willing to sign the Informed Consent (IC) / HIPAA and PHI Release forms to participate in the study

Exclusion Criteria

* 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
* Subjects without the required types of knee implants
* Subjects who are unable to walk up and down a ramp, perform a deep knee bend or rising from that kneeling position without aid or support and without pain
* Subjects who have had other surgical procedures conducted within the past six months that will prohibit them from performing the study activities

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No