Clinical trial NCT03088748: Kinematics in Posterior Cruciate Retaining and Bi-Cruciate Retaining Total Knee Replacements
Official title: Kinematics in Posterior Cruciate Retaining and Bi-Cruciate Retaining Total Knee Replacements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Replacement, Knee
Osteoarthritis, Knee
Keywords: total knee arthroplasty
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2017-03-23
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with a Smith \& Nephew Journey II posterior cruciate retaining (PCR) or a Smith \& Nephew Journey II bi-cruciate retaining (BCR) total knee arthroplasty (TKA) implanted by Dr. Harold E. Cates.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lateral Kinematics Translations While Ascending Ramp
timeFrame: Baseline
measure: Medial Kinematics Translations While Ascending Ramp
timeFrame: Baseline
measure: Axial Rotation While Ascending Ramp
timeFrame: Baseline
measure: Lateral Kinematics Translations While Descending Ramp
timeFrame: Baseline
measure: Medial Kinematics Translations While Descending Ramp
timeFrame: Baseline
measure: Axial Rotation While Descending Ramp
timeFrame: Baseline
measure: Lateral Kinematics Translations During Deep Knee Bend
timeFrame: Baseline
measure: Medial Kinematics Translations During Deep Knee Bend
timeFrame: Baseline
measure: Axial Rotation During Deep Knee Bend
timeFrame: Baseline
measure: Maximum Flexion During Deep Knee Bend
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Foundation for Education and Research
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Orthopaedic Clinic
state: Tennessee
city: Knoxville
country: United States
facility: The University of Tennessee
state: Tennessee
Study officials:
affiliation: The University of Tennessee
name: Richard Komistek
role: PRINCIPAL_INVESTIGATOR
References: