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van CCT (UK)

van CCT (UK)

Total knee arthroplasty, the long and mid term follow up.

- candidate number16383
- NTR NumberNTR4382
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-feb-2014
- Secondary IDs13N102 
- Public TitleTotal knee arthroplasty, the long and mid term follow up.
- Scientific TitleAnalysis of the long term follow up of the Maxim TKA compared to the Vanguard Total Knee syatem at mid term.
- ACRONYMTKA, Vanguard, Maxim, Survival, mid term, long term
- hypothesisWe hypothesize that the Vanguard TKA show similar and comparable outcome measures and survival as the Maxim TKA
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Post-traumatic arthritis, Knee osteoarthritis
- Inclusion criteria- Operated between January 1999 and December 2002 (Maxim group) - Operated between June 2006-december 2008 (Vanguard group) - Completed the full follow up - Deceased with a known TKA revision
- Exclusion criteria- Patients who did not completed the full follow up - Deceased without a known TKA revision
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 7-feb-2014
- planned closingdate31-dec-2015
- Target number of participants1500
- Interventionsthe Maxim total knee System (Biomet) will be compared with a cohort of consecutive patients utilizing the Vanguard total knee System (Biomet)
- Primary outcomeComparing the initial and long- and mid term survival of the Maxim and Vanguard TKA. The primary endpoint will be defined as revision of the the Maxim or Vanguard TKA for any kind. o Adverse events: all postoperative adverse events related to the implant will be evaluated and compared between both groups.
- Secondary outcomeComparing the initial long- and mid term clinical results of the Maxim and Vanguard TKA o Standard clinical parameters (Physical examination and Questionnaires) will be evaluated and compared between both groups.
- Timepoints5 and >10 years follow up
- Trial web siteNA
- statusopen: patient inclusion
- Sponsor/Initiator Orbis Medisch Centrum, Orthopedic Department
- Funding
(Source(s) of Monetary or Material Support)
Stichting ter bevordering van de orthopaedische kwaliteit
- Publications
- Brief summaryThe mid- and long term survival and patient reported outcome measures (PROMs) for this prosthesis are unknown. The revision rate of an implant is an important outcome measure in evaluating survival of a new TKA design. To make survival data comparable between different prostheses designs, revision is used as a failure end-point. The rate of ‘Revisions per 100 observed component years’ can then be calculated. According to a recent study which combined the national databases of 6 different countries there are 1.26 revisions per 100 observed component years. This number is the average revision rate for different knee designs in multiple countries. Clinical studies are valuable in addition to registry data as they can provide more details on the study population, the procedure and other aspects of the outcome. If the early survival rate of the Vanguard is known, and is comparable with other prostheses as well as its predecessor the Maxim, this would justify further use of the Vanguard TKA.
- Main changes (audit trail)
- RECORD12-feb-2014 - 1-apr-2014

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