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

Knee Osteoarthritis Clinical Trial

Official title:

Analysis of Competitive PCR and PS Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04321356
• Other study ID #: 3187FB WIRB20180745 Extension
• Status: Completed
• Start date: February 24, 2020
• Est. completion date: May 16, 2022

Study information

• Verified date: February 2023
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 16, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Total Knee Arthroplasty

Intervention

Device:
• Triathlon PCR TKA
Total Knee Arthroplasty System
• Triathlon PS TKA
Total Knee Arthroplasty System
• Persona PCR TKA
Total Knee Arthroplasty System
• Persona PS TKA
Total Knee Arthroplasty System

Locations

Country	Name	City	State
United States	Tennessee Orthopaedic Clinic	Knoxville	Tennessee
United States	The University of Tennessee	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity	Anterior Posterior (AP) translations, in mm, of medial femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the medial femoral condyle, and negative values indicate posterior motion of the medial femoral condyle.	3 months post-operative
Primary	Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity	Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the lateral femoral condyle, and negative values indicate posterior motion of the lateral femoral condyle.	3 months post-operative
Primary	Maximum Flexion, in Degrees, During Deep Knee Bend Activity	Maximum weight-bearing flexion, in degrees, during deep knee bend activity	3 months post-operative
Primary	Axial Rotation, in Degrees, During Deep Knee Bend Activity	Axial rotation (AR), in degrees, during deep knee bend activity. Positive values indicate external femorotibial axial rotation, and negative values indicate internal femorotibial axial rotation.	3 months post-operative