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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

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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