Knee Prosthesis
Conditions
Keywords
Knee Prosthesis, Total Knee Arthroplasty, Cruciate Retaining, Posterior Cruciate Retaining
Brief summary
This study will compare the kinematics data collected from patients with implants created by different manufacturers to see which of these implants provides a more normal-like kinematic pattern compared to the normal knee.
Detailed description
A better understanding of knee joint kinematics is important to explain premature polyethylene wear failures within knee implants and to help design a prosthesis that most closely approximates the normal knee. Therefore, the objectives for this study are to compare the in vivo kinematic patterns for subjects implanted with either a Stryker Triathlon Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) or Zimmer NexGen PCR TKA design to determine if there are any kinematic differences between these TKA designs. Each subject will be asked to undergo a fluoroscopic evaluation while performing weight-bearing activities under surveillance using the University of Tennessee's new mobile tracking fluoroscopic unit while performing deep knee bend and ramp up and ramp down activities. The mobile fluoroscopy unit is approved for use by the State of Tennessee on a study-by-study basis after IRB approval is obtained for each study.
Interventions
DEVICEStryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)
The fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.
DEVICEZimmer PCR TKA
The fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.
Sponsors
Stryker Orthopaedics
The University of Tennessee, Knoxville
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Must be at least 3 months post-operative with no other surgical procedures conducted within the past 6 months * Must have body weight of less than 250 lbs * Must have Body Mass Index of less than 38 * Must be judged clinically successful with a Knee Society Score \>90 * Must have 100% post-operative passive flexion with no ligamentous laxity or pain * Must be able to walk on level ground without aid of any kind * Must be able to ascend and descend a ramp with a 10 degree incline with no assistance * Must be willing to sign both Informed Consent and HIPAA forms * Must be between 160 cm (5'3) and 193 cm (6'4) tall
Exclusion criteria
* Pregnant or potentially pregnant females * Unwilling to sign Informed Consent or HIPAA forms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kinematics - Deep Knee Bend Activity | 3 months post-operative | Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity |
| Kinematics - Ramp up Activity | 3 months post-operative | Lateral Anterior Posterior (LAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] and Medial Anterior Posterior (MAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] translations, and Axial Rotation (AR) \[during 3 moments - 0-33%, 33-66% and 66-100%\] of medial femoral condyles during ramp up activity |
| Kinematics - Ramp Down Activity | 3 months post-operative | Lateral Anterior Posterior (LAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] and Medial Anterior Posterior (MAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] translations, and Axial Rotation (AR) \[during 3 moments - 0-33%, 33-66% and 66-100%\] of medial femoral condyles during ramp down activity |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With a Stryker Triathlon CR TKA Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.
Stryker PCR TKA | 25 |
| Patients With a Zimmer PCR TKA Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.
Zimmer PCR TKA | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Patients With a Zimmer PCR TKA | Patients With a Stryker Triathlon CR TKA | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 18 Participants | 36 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Continuous | 70.6 years STANDARD_DEVIATION 9.4 | 68.7 years STANDARD_DEVIATION 6.4 | 69.60 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 19 Participants | 2 Participants | 21 Participants |
| Sex: Female, Male Male | 6 Participants | 23 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Kinematics - Deep Knee Bend Activity
Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity
Time frame: 3 months post-operative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With a Stryker Triathlon CR TKA | Kinematics - Deep Knee Bend Activity | Lateral Anterior Posterior Deep Knee Bend | -0.43 mm | Standard Deviation 3.43 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Deep Knee Bend Activity | Maximum Flexion Deep knee bend | 107.80 mm | Standard Deviation 8.5 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Deep Knee Bend Activity | Medial Anterior Posterior Deep Knee Bend | 3.51 mm | Standard Deviation 2.68 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Deep Knee Bend Activity | Axial Rotation Deep Knee Bend | 5.20 mm | Standard Deviation 3.93 |
| Patients With a Zimmer PCR TKA | Kinematics - Deep Knee Bend Activity | Axial Rotation Deep Knee Bend | 0.75 mm | Standard Deviation 5.12 |
| Patients With a Zimmer PCR TKA | Kinematics - Deep Knee Bend Activity | Lateral Anterior Posterior Deep Knee Bend | -1.00 mm | Standard Deviation 3.23 |
| Patients With a Zimmer PCR TKA | Kinematics - Deep Knee Bend Activity | Medial Anterior Posterior Deep Knee Bend | -0.42 mm | Standard Deviation 2.2 |
| Patients With a Zimmer PCR TKA | Kinematics - Deep Knee Bend Activity | Maximum Flexion Deep knee bend | 107.20 mm | Standard Deviation 11 |
Primary
Kinematics - Ramp Down Activity
Lateral Anterior Posterior (LAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] and Medial Anterior Posterior (MAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] translations, and Axial Rotation (AR) \[during 3 moments - 0-33%, 33-66% and 66-100%\] of medial femoral condyles during ramp down activity
Time frame: 3 months post-operative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp Down Activity | Medial Anterior Posterior Translation 33% to 66% | -.75 mm | Standard Deviation 2.42 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp Down Activity | Medial Anterior Posterior Translation 66% to 100% | 1.29 mm | Standard Deviation 2.34 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp Down Activity | Lateral Anterior Posterior Translation 66% to 100% | 0.83 mm | Standard Deviation 2.56 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp Down Activity | Axial Rotation 0% to 33% | -0.44 mm | Standard Deviation 2.76 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp Down Activity | Lateral Anterior Posterior Translation 33% to 66% | -1.25 mm | Standard Deviation 1.86 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp Down Activity | Axial Rotation 33% to 66% | 0.67 mm | Standard Deviation 3.09 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp Down Activity | Medial Anterior Posterior Translation 0% to 33% | -0.87 mm | Standard Deviation 2.19 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp Down Activity | Axial Rotation 66% to 100% | 0.59 mm | Standard Deviation 3.39 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp Down Activity | Lateral Anterior Posterior Translation 0% to 33% | -0.57 mm | Standard Deviation 2.33 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp Down Activity | Axial Rotation 66% to 100% | -0.54 mm | Standard Deviation 3.86 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp Down Activity | Lateral Anterior Posterior Translation 0% to 33% | -1.11 mm | Standard Deviation 2.27 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp Down Activity | Lateral Anterior Posterior Translation 33% to 66% | -0.96 mm | Standard Deviation 2.6 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp Down Activity | Lateral Anterior Posterior Translation 66% to 100% | 0.15 mm | Standard Deviation 2.37 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp Down Activity | Medial Anterior Posterior Translation 0% to 33% | -0.92 mm | Standard Deviation 1.95 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp Down Activity | Medial Anterior Posterior Translation 66% to 100% | -0.31 mm | Standard Deviation 1.44 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp Down Activity | Axial Rotation 0% to 33% | 0.24 mm | Standard Deviation 3.19 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp Down Activity | Axial Rotation 33% to 66% | 1.22 mm | Standard Deviation 3.97 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp Down Activity | Medial Anterior Posterior Translation 33% to 66% | 0 mm | Standard Deviation 1.27 |
Primary
Kinematics - Ramp up Activity
Lateral Anterior Posterior (LAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] and Medial Anterior Posterior (MAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] translations, and Axial Rotation (AR) \[during 3 moments - 0-33%, 33-66% and 66-100%\] of medial femoral condyles during ramp up activity
Time frame: 3 months post-operative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp up Activity | Lateral Anterior Posterior Translation 0% to 33% | -0.31 mm | Standard Deviation 2.41 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp up Activity | Medial Anterior Posterior Translation 33% to 66% | -1.04 mm | Standard Deviation 3.36 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp up Activity | Medial Anterior Posterior Translation 66% to 100% | 0.48 mm | Standard Deviation 2.35 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp up Activity | Lateral Anterior Posterior Translation 66% to 100% | -0.23 mm | Standard Deviation 2.69 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp up Activity | Axial Rotation 0% to 33% | -1.33 mm | Standard Deviation 4.03 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp up Activity | Axial Rotation 33% to 66% | -0.15 mm | Standard Deviation 3.17 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp up Activity | Lateral Anterior Posterior Translation 33% to 66% | -0.94 mm | Standard Deviation 2.26 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp up Activity | Axial Rotation 66% to 100% | 0.95 mm | Standard Deviation 2.19 |
| Patients With a Stryker Triathlon CR TKA | Kinematics - Ramp up Activity | Medial Anterior Posterior Translation 0% to 33% | -1.31 mm | Standard Deviation 3.43 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp up Activity | Axial Rotation 66% to 100% | -0.03 mm | Standard Deviation 3.96 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp up Activity | Axial Rotation 0% to 33% | -2.69 mm | Standard Deviation 3.99 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp up Activity | Lateral Anterior Posterior Translation 33% to 66% | -0.61 mm | Standard Deviation 2.42 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp up Activity | Lateral Anterior Posterior Translation 66% to 100% | -0.07 mm | Standard Deviation 2.7 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp up Activity | Medial Anterior Posterior Translation 0% to 33% | -1.88 mm | Standard Deviation 2.07 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp up Activity | Medial Anterior Posterior Translation 33% to 66% | 0.41 mm | Standard Deviation 2.16 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp up Activity | Medial Anterior Posterior Translation 66% to 100% | -0.09 mm | Standard Deviation 1.63 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp up Activity | Axial Rotation 33% to 66% | 1.27 mm | Standard Deviation 3.42 |
| Patients With a Zimmer PCR TKA | Kinematics - Ramp up Activity | Lateral Anterior Posterior Translation 0% to 33% | 0.20 mm | Standard Deviation 2.75 |