No registrations found.
ID
Source
Brief title
Health condition
Knee Osteoarthritis
Sponsors and support
Intervention
Outcome measures
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
- VAS-score
- Maximum step height
Background 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.
Study objective
The null hypothesis is that the mobile bearing does not give a greater flexion than the fixed bearing TKP.
Study design
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.
Intervention
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.
Hengstdal 3
Wilco Jacobs
Nijmegen 6522 JV
The Netherlands
+31 (0)24 3659067
w.jacobs@maartensliniek.nl
Hengstdal 3
Wilco Jacobs
Nijmegen 6522 JV
The Netherlands
+31 (0)24 3659067
w.jacobs@maartensliniek.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1231 |
| NTR-old | NTR1276 |
| Other | : 29 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |