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

Completed

Conditions studied: Arthroplasty, Replacement, Knee, Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT03088748

Run by

The University of Tennessee, Knoxville

People needed

50

Starts

2017-01-01

Expected to finish

2020-11-09

Last updated by the study team

2021-10-12

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Erlanger Health System — Chattanooga, Tennessee, United States
• Tennessee Foundation for Education and Research — Knoxville, Tennessee, United States
• Tennessee Orthopaedic Clinic — Knoxville, Tennessee, United States
• The University of Tennessee — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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