Status:
COMPLETED
Analysis of Competitive Posterior Cruciate Retaining (PCR) and Posterior Stabilized (PS) Total Knee Arthroplasty (TKA)
Lead Sponsor:
The University of Tennessee, Knoxville
Collaborating Sponsors:
Smith & Nephew, Inc.
Conditions:
Knee Osteoarthritis
Total Knee Arthroplasty
Eligibility:
All Genders
18-85 years
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 P...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 24 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 16 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04321356
Start Date
February 24 2020
End Date
May 16 2022
Last Update
November 28 2023
Active Locations (2)
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1
Tennessee Orthopaedic Clinic
Knoxville, Tennessee, United States, 37923
2
The University of Tennessee
Knoxville, Tennessee, United States, 37996