Knee Osteoarthritis
Conditions
Interventions
The trial treatments are the balanSysTM fixed and mobile bearing total knee prostheses. The treatments are both CE-marked and currently in use in all trial centers. The device is a surgically invasive
Sponsors
Mathys Medical Ltd
Eligibility
Inclusion criteria
Inclusion criteria: The patient must: 1. Have been diagnosed with osteoarthritis (also referred to as gonarthrosis). 2. Be a candidate for primary total knee arthroplasty for this reason. 3. Be expected to undergo only one arthroplasty procedure in next 12 months. 4. Be willing to attend all the follow-up examinations. 5. Be expected to make a full recovery. 6. Be 60 to 75 years old. 7. Have a pre-operative alignment (varus or valgus) < 10° 8. Have a BMI < 30 9. Be living independently.
Exclusion criteria
Exclusion criteria: The patient must not: 1. Be undergoing revision arthroplasty. 2. Missing or having an insufficient posterior cruciate ligament. 3. Need cementing of the tibial stem due to osteoporosis. 4. Be currently enrolled in a clinical investigation with either a drug or an investigational device or has been enrolled in such an investigation during the last 6 months. 5. Have a history of any allergic reaction to any medical device required for this study. 6. Suffer from heart or lung disease. 7. Have any contraindication to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the active flexion at one year. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are, also measured at one year: * Knee Society clinical rating scale including: - Passive range of motion - AP-laxity of the knee joint in 90 and 25 degrees - Axial rotation of the lower leg - VAS-score - Maximum step height | — |
Contacts
Public ContactWilco Jacobs
Sint Maartenskliniek Hengstdal 3
Outcome results
None listed