|- candidate number||3199|
|- NTR Number||NTR1276|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-apr-2008|
|- Secondary IDs||29 |
|- Public Title||Knee flexion after two types of knee arthroplasty|
|- Scientific Title||ACTIVE FLEXION AFTER TOTAL KNEE ARTHROPLASTY WITH THE BALANSYS PROSTHESIS WITH A FIXED BEARING COMPARED TO A MOBILE BEARING.|
|- hypothesis||The null hypothesis is that the mobile bearing does not give a greater flexion than the fixed bearing TKP. |
|- Healt Condition(s) or Problem(s) studied||Osteoarthritis, Knee, Arthroplasty |
|- 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||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
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2002|
|- planned closingdate||1-jun-2008|
|- Target number of participants||124|
|- 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, implantable device for long-term use and therefore categorized as Class IIb.|
|- Primary outcome||The primary endpoint of the study is the active flexion at one year. |
|- Secondary outcome||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
- Maximum step height
|- Timepoints||The patients included in the study will be seen at standard follow-up moments. The fixed moments are preoperative, and 3, 6, and 12 months postoperatively.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Wilco Jacobs|
|- CONTACT for SCIENTIFIC QUERIES|| Wilco Jacobs|
|- Sponsor/Initiator ||Mathys Medical Ltd|
(Source(s) of Monetary or Material Support)
|Mathys Medical Ltd|
|- Brief summary||Jacobs WCH, Christen B, Wymenga AB, Schuster A, van der Schaaf DB, ten ham A, Wehrli U. Functional performance of mobile versus fixed bearing total knee prostheses; a randomised controlled trial. Knee Surg Sports Traumatol Arthrosc 2012;20(8):1450-55.|
|- Main changes (audit trail)|
|- RECORD||14-apr-2008 - 10-jan-2013|