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

The University of Tennessee, Knoxville

Status

Completed

Conditions

Arthroplasty, Replacement, Knee

Osteoarthritis, Knee

Treatments

Device: Journey II posterior bi-cruciate retaining total knee arthroplasty

Device: Journey II posterior cruciate retaining total knee arthroplasty

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT03088748

3187FB WIRB20180745

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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