Not provided
Not provided
Not provided
Not provided
Not provided
Mobile-bearing insert dislocation
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stryker Nordic | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this study is to compare the fixed bearing (FB) Triathlon knee (Stryker, USA) and the mobile bearing (MB) Triathlon knee (Stryker, USA) and study the effect of implant design on kinematics and micromotion. During two tasks the kinematics measured with fluoroscopy (kinematics and movement of the polyethylene bearing). Roentgen Stereophotogrammetric Analysis (RSA) will be used to evaluate micromotion between prosthesis and the bone for the MB and FB Triathlon knee.
The goal of this study is to perform a kinematic evaluation of a MB and FB knee prosthesis designs (Triathlon, Stryker, USA), by means of fluoroscopy and RSA and compare the different designs. The findings of this study will contribute to improve total knee designs and improve rehabilitation strategies.
Objectives:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triathlon Mobile-bearing | Experimental | Primary total knee replacement with cemented Triathlon posterior stabilized mobile-bearing |
|
| Triathlon Fixed-bearing | Active Comparator | Primary total knee replacement with cemented Triathlon posterior stabilized fixed-bearing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triathlon PS total knee system with mobile-bearing | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Migration, measured by means of RSA on the first 20 patients (fluoroscopy subset) | Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA) | First or second day postoperatively, 6 months, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Migration, measured by means of RSA | Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA) | First or second day postoperatively, 6 months, 1 year and annually thereafter up to 20 years |
| Assessment of the knee flexion range by means of fluoroscopy during step-up motions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| R.G.H.H. Nelissen, MD, PhD | Head of Department of Orthopaedics, Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedics, Leiden University Medical Center | Leiden | 2300RC | Netherlands |
IPD analysis is scheduled
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Triathlon PS total knee system with fixed-bearing |
| Device |
|
|
Patients will be asked to perform three step-up motions (height 18 cm) with bare feet in front of a flat panel fluoroscope. Outcome measurement is knee flexion range (degrees). |
| 6 months and 13 months postoperatively |
| Assessment of the axial rotation range of femoral component by means of fluoroscopy during step-up motions | Patients will be asked to perform three step-up motions (height 18 cm) with bare feet in front of a flat panel fluoroscope. Outcome measurement is axial rotation range of femoral component (degrees). | 6 months and 13 months postoperatively |
| Assessment of the knee flexion range by means of fluoroscopy during lunge motions | Patients will be asked to perform three lunge motions (height 18 cm) with bare feet in front of a flat panel fluoroscope. Outcome measurement is knee flexion range (degrees). | 6 months and 13 months postoperatively |
| Assessment of the axial rotation range of femoral component by means of fluoroscopy during lunge motions | Patients will be asked to perform three lunge motions (height 18 cm) with bare feet in front of a flat panel fluoroscope. Outcome measurement is axial rotation range of femoral component (degrees). | 6 months and 13 months postoperatively |
| Investigation of clinical performance and patient outcome with the Knee Society Score (KSS) | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. | Within 3 months prior to surgery, 6 months postoperatively, 1 year and and annually thereafter up to 20 years |