Clinical trial NCT04321356: Analysis of Competitive Posterior Cruciate Retaining (PCR) and Posterior Stabilized (PS) Total Knee Arthroplasty (TKA)
Official title: Analysis of Competitive PCR and PS Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Total Knee Arthroplasty
Knee
Keywords: Total Knee Arthroplasty
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2020-03-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
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 Stryker Triathlon PCR, Stryker Triathlon PS, Zimmer Persona PCR, or Zimmer Persona PS 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 Stryker Posterior Cruciate Retaining (PCR) , Stryker Posterior Stabilized (PS), Zimmer PCR, and Zimmer PS Total Knee Arthroplasty (TKAs). Our lab has previously collected data for the Smith \& Nephew PCR, bi-cruciate retaining (BCR), and bi-cruciate stabilized (BCS) TKA.

Detailed description: The objective for this study is to analyze the in vivo kinematics for subjects implanted with either a Stryker PCR, Stryker PS, Zimmer PCR, and Zimmer PS TKA and to compare those patterns to subjects having a normal knee from our previous study and to those patterns from subjects having a Smith \& Nephew PCR, BCR, and BCS TKA.

Eligibility criteria: Inclusion Criteria:

1. Subjects will have one of the following implant types: 1) Stryker Triathlon PCR TKA (28 subjects), 2) Stryker Triathlon PS TKA (28 subjects), 3) Zimmer Persona PCR TKA (28 subjects) and 4) Zimmer Persona PS TKA (28 subjects).
2. Patients must be at least three months post-operative.
3. Participants must not experience any pain or other post-operative complications.
4. Participants must have a stable TKA and be capable of performing a deep knee bend activity.
5. Participants must weigh less than 300 lbs., not underweight (BMI \< 18.5) or too obese (BMI\>35).
6. Must be in the age range of 18 years to 85 years (both inclusive).
7. Participants must be able to perform the required activities without concern.
8. Subjects must be willing to sign the Informed Consent (IC) form to participate in the study.
9. Patients who do not have previous surgery on the implanted knee that might restrict their movement.

Exclusion Criteria:

1. Pregnant, potentially pregnant, lactating females or of childbearing age. 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. (All potential female study patients will be asked if they are premenopausal or if they have undergone a hysterectomy. If the possibility of pregnancy exists, a pregnancy kit will be given to the patient at the informed consent meeting, just prior to the fluoro. Results of the test will be recorded in a test log. Any female patient showing a positive test will be excluded from testing.)
2. Subjects without the required type of knee implant.
3. Cannot have pain in other parts of the body that would prohibit the subject from performing the activities).
4. Cannot have ligamentous pain and/or laxity.
5. Unwilling to sign IC/HIPAA form(s).
6. Does not speak English.
7. Patients who have enrolled in a fluoroscopic kinematic study within the past year.
8. Patients currently involved in any personal injury litigation, medical/legal or worker's compensation claims.
9. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
10. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability.

Primary outcomes:
measure: Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity
timeFrame: 3 months post-operative
measure: Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity
timeFrame: 3 months post-operative
measure: Maximum Flexion, in Degrees, During Deep Knee Bend Activity
timeFrame: 3 months post-operative
measure: Axial Rotation, in Degrees, During Deep Knee Bend Activity
timeFrame: 3 months post-operative
Secondary outcomes:
Other outcomes:
Locations:
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, PhD
role: PRINCIPAL_INVESTIGATOR
References: