Non-inflammatory degenerative joint disease/total knee replacement Musculoskeletal Diseases Total knee replacement
Conditions
Interventions
Study device:
Required Components:
1. Triathlon® Cruciate Retaining Total Knee System with X3® polyethylene insert
2. Resurfaced Patella
Required Instrumentation:
1. Kinematic aligned ShapeMatch
Sponsors
Stryker SA (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has signed an EC approved, study specific Informed Patient Consent Form 2. Patient is a male or non-pregnant female, skeletally mature and age 18-80 years at the time of study device implantation 3. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD) 4. Patient is a candidate for a primary total knee replacement 5. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation
Exclusion criteria
Exclusion criteria: 1. Patient has a Body Mass Index (BMI) = 40 2. Patient age = 80 3. Patient has a varus or valgus deformity greater than 10° or flexion contracture greater than 20° 4. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation 5. Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year 6. Patient requires bilateral total knee replacements, or has a history of contralateral partial or total knee replacement 7. Patient has any implanted device that would be incompatible with MRI procedures 8. Patient has chronic heart failure (NYHA Stage = 2) 9. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device 10. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget?s disease) leading to progressive bone deterioration 11. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days) 12. Patient requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint 13. Patient has a known sensitivity to device materials 14. Patient is a prisoner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate by means of fluoroscopy and functional evaluation that TKR?s performed using a kinematic aligned ShapeMatch Cutting Guide provides better short term kinematic and functional improvement compared to those TKR?s performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall 1. Consistent femoral-tibial pivot point location 2. Consistent femoral Anterior-Posterior translation 3. Consistent external rotation during extension 4. Better Get-up-and-go test | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare pain, function and health related quality of life (QOL) between the kinematic aligned ShapeMatch Cutting Guide group and the neutral overall limb aligned groups using cutting guides and conventional instrumentation, respectively. 2. To evaluate the cost-benefit ratios between those TKR?s performed using kinematic aligned ShapeMatch Cutting Guides and those TKR?s performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall limb alignment. To meet this objective, the following criteria will be satisfied: 2.1. Lower procedural and hospital logistic costs 2.2. Lower blood loss 2.3. Less (pain) medication 2.4. Higher activity score on discharge 2.5. Faster functional improvement 3. To compare device-related adverse events between those knees implanted using the kinematic aligned ShapeMatch Cutting Guide and those implanted using ShapeMatch cutting guides modified to provide neutral overall limb alignment or those implanted using conventional instrumentation intended to achieve neutral overall limb alignment. Published complication rates with similar devices, as well as complications reported in the investigational and control groups, will be reviewed. | — |
Countries
Germany, Italy, United Kingdom
Outcome results
None listed