N/A
N=100
Analysis of Competitive Posterior Cruciate Retaining (PCR) and Posterior Stabilized (PS) Total Knee Arthroplasty (TKA)
Knee Osteoarthritis · Total Knee Arthroplasty · Knee
Bottom Line
View on ClinicalTrials.gov: NCT04321356 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity — 4.2; -0.4; -0.5; -3.3 millimeters
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Triathlon PCR TKA (Device); Triathlon PS TKA (Device); Persona PCR TKA (Device); Persona PS TKA (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Tennessee, Knoxville
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity |
4.2; -0.4; -0.5; -3.3 | — |
| PRIMARY Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity |
0.7; -3.3; 0.6; -5.2 | — |
| PRIMARY Maximum Flexion, in Degrees, During Deep Knee Bend Activity |
107; 101; 107; 114 | — |
| PRIMARY Axial Rotation, in Degrees, During Deep Knee Bend Activity |
4.3; 3.6; -1.5; 2.8 | — |
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT04321356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.