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Knee flexion after two types of knee arthroplasty


- candidate number3199
- NTR NumberNTR1276
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-apr-2008
- Secondary IDs29 
- Public TitleKnee flexion after two types of knee arthroplasty
- Scientific TitleACTIVE FLEXION AFTER TOTAL KNEE ARTHROPLASTY WITH THE BALANSYS PROSTHESIS WITH A FIXED BEARING COMPARED TO A MOBILE BEARING.
- ACRONYMN/A
- hypothesisThe null hypothesis is that the mobile bearing does not give a greater flexion than the fixed bearing TKP.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Knee, Arthroplasty
- Inclusion criteriaThe 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 criteriaThe 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2002
- planned closingdate1-jun-2008
- Target number of participants124
- InterventionsThe 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 outcomeThe primary endpoint of the study is the active flexion at one year.
- Secondary outcomeThe 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
- TimepointsThe 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 siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Wilco Jacobs
- CONTACT for SCIENTIFIC QUERIES Wilco Jacobs
- Sponsor/Initiator Mathys Medical Ltd
- Funding
(Source(s) of Monetary or Material Support)
Mathys Medical Ltd
- PublicationsN/A
- Brief summaryJacobs 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)
- RECORD14-apr-2008 - 10-jan-2013


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