Knee, Knee Osteoarthritis, Total Knee Arthroplasty
Conditions
Keywords
Total Knee Arthroplasty
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 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.
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 having a normal knee from our previous study and to those patterns from subjects having a Smith & Nephew PCR, BCR, and BCS TKA.
Interventions
DEVICETriathlon PCR TKA
Total Knee Arthroplasty System
DEVICETriathlon PS TKA
Total Knee Arthroplasty System
DEVICEPersona PCR TKA
Total Knee Arthroplasty System
DEVICEPersona PS TKA
Total Knee Arthroplasty System
Sponsors
Smith & Nephew, Inc.
The University of Tennessee, Knoxville
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity | 3 months post-operative | 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. |
| Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity | 3 months post-operative | 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. |
| Maximum Flexion, in Degrees, During Deep Knee Bend Activity | 3 months post-operative | Maximum weight-bearing flexion, in degrees, during deep knee bend activity |
| Axial Rotation, in Degrees, During Deep Knee Bend Activity | 3 months post-operative | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stryker Triathlon PCR TKA Subjects implanted with a Stryker Triathlon PCR TKA
Triathlon PCR TKA: Total Knee Arthroplasty System | 31 |
| Stryker Triathlon PS TKA Subjects implanted with a Stryker Triathlon PS TKA
Triathlon PS TKA: Total Knee Arthroplasty System | 26 |
| Zimmer Persona PCR TKA Subjects implanted with a Zimmer Persona PCR TKA
Persona PCR TKA: Total Knee Arthroplasty System | 29 |
| Zimmer Persona PS TKA Subjects implanted with a Zimmer Persona PS TKA
Persona PS TKA: Total Knee Arthroplasty System | 14 |
| Total | 100 |
Baseline characteristics
| Characteristic | Total | Stryker Triathlon PS TKA | Zimmer Persona PCR TKA | Zimmer Persona PS TKA | Stryker Triathlon PCR TKA |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants | 26 Participants | 29 Participants | 14 Participants | 31 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — |
| Region of Enrollment United States | 100 participants | 26 participants | 29 participants | 14 participants | 31 participants |
| Sex: Female, Male Female | 49 Participants | 12 Participants | 17 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 51 Participants | 14 Participants | 12 Participants | 6 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 26 | 0 / 29 | 0 / 14 |
| other Total, other adverse events | 0 / 31 | 0 / 26 | 0 / 29 | 0 / 14 |
| serious Total, serious adverse events | 0 / 31 | 0 / 26 | 0 / 29 | 0 / 14 |
Outcome results
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.
Time frame: 3 months post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stryker Triathlon PCR TKA | Axial Rotation, in Degrees, During Deep Knee Bend Activity | 4.3 degrees | Standard Deviation 4.4 |
| Stryker Triathlon PS TKA | Axial Rotation, in Degrees, During Deep Knee Bend Activity | 3.6 degrees | Standard Deviation 3.7 |
| Zimmer Persona PCR TKA | Axial Rotation, in Degrees, During Deep Knee Bend Activity | -1.5 degrees | Standard Deviation 4 |
| Zimmer Persona PS TKA | Axial Rotation, in Degrees, During Deep Knee Bend Activity | 2.8 degrees | Standard Deviation 4.7 |
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.
Time frame: 3 months post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stryker Triathlon PCR TKA | Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity | 0.7 millimeters | Standard Deviation 3.6 |
| Stryker Triathlon PS TKA | Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity | -3.3 millimeters | Standard Deviation 3.5 |
| Zimmer Persona PCR TKA | Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity | 0.6 millimeters | Standard Deviation 2.3 |
| Zimmer Persona PS TKA | Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity | -5.2 millimeters | Standard Deviation 4.8 |
Primary
Maximum Flexion, in Degrees, During Deep Knee Bend Activity
Maximum weight-bearing flexion, in degrees, during deep knee bend activity
Time frame: 3 months post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stryker Triathlon PCR TKA | Maximum Flexion, in Degrees, During Deep Knee Bend Activity | 107 degrees | Standard Deviation 11 |
| Stryker Triathlon PS TKA | Maximum Flexion, in Degrees, During Deep Knee Bend Activity | 101 degrees | Standard Deviation 16 |
| Zimmer Persona PCR TKA | Maximum Flexion, in Degrees, During Deep Knee Bend Activity | 107 degrees | Standard Deviation 11 |
| Zimmer Persona PS TKA | Maximum Flexion, in Degrees, During Deep Knee Bend Activity | 114 degrees | Standard Deviation 17 |
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.
Time frame: 3 months post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stryker Triathlon PCR TKA | Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity | 4.2 millimeters | Standard Deviation 3.6 |
| Stryker Triathlon PS TKA | Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity | -0.4 millimeters | Standard Deviation 3.4 |
| Zimmer Persona PCR TKA | Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity | -0.5 millimeters | Standard Deviation 2.1 |
| Zimmer Persona PS TKA | Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity | -3.3 millimeters | Standard Deviation 4.8 |