Analysis of Competitive Posterior Cruciate Retaining (PCR) and Posterior Stabilized (PS) Total Knee Arthroplasty (TKA)

The University of Tennessee, Knoxville

Status

Completed

Conditions

Knee

Knee Osteoarthritis

Total Knee Arthroplasty

Treatments

Device: Persona PS TKA

Device: Triathlon PCR TKA

Device: Persona PCR TKA

Device: Triathlon PS TKA

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04321356

3187FB WIRB20180745 Extension

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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).
Patients must be at least three months post-operative.
Participants must not experience any pain or other post-operative complications.
Participants must have a stable TKA and be capable of performing a deep knee bend activity.
Participants must weigh less than 300 lbs., not underweight (BMI < 18.5) or too obese (BMI>35).
Must be in the age range of 18 years to 85 years (both inclusive).
Participants must be able to perform the required activities without concern.
Subjects must be willing to sign the Informed Consent (IC) form to participate in the study.
Patients who do not have previous surgery on the implanted knee that might restrict their movement.

Exclusion criteria

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.)
Subjects without the required type of knee implant.
Cannot have pain in other parts of the body that would prohibit the subject from performing the activities).
Cannot have ligamentous pain and/or laxity.
Unwilling to sign IC/HIPAA form(s).
Does not speak English.
Patients who have enrolled in a fluoroscopic kinematic study within the past year.
Patients currently involved in any personal injury litigation, medical/legal or worker's compensation claims.
Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability.