The null hypothesis is that the mobile bearing does not give a greater flexion than the fixed bearing TKP.
ID
Bron
Verkorte titel
Aandoening
Knee Osteoarthritis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoint of the study is the active flexion at one year.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The null hypothesis is that the mobile bearing does not give a greater flexion than the fixed bearing TKP.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Publiek
Hengstdal 3
Wilco Jacobs
Nijmegen 6522 JV
The Netherlands
+31 (0)24 3659067
w.jacobs@maartensliniek.nl
Wetenschappelijk
Hengstdal 3
Wilco Jacobs
Nijmegen 6522 JV
The Netherlands
+31 (0)24 3659067
w.jacobs@maartensliniek.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1231 |
| NTR-old | NTR1276 |
| Ander register | : 29 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |