search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


10 years survival of the cemented and uncemented total hip arthroplasty


- candidate number16407
- NTR NumberNTR4383
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-feb-2014
- Secondary IDs14N03 14.009
- Public Title10 years survival of the cemented and uncemented total hip arthroplasty
- Scientific Title10 years survival of the cemented and uncemented Anatomic Benoist Girard (ABG) total hip arthroplasty A retrospective study
- ACRONYMAnatomic Benoist Girard, ABG, Cemented, uncemented THP, THA
- hypothesisWe hypothesize that there is no difference between the survival and follow of the uncemented and cemented ABG THA.
- Healt Condition(s) or Problem(s) studiedCoxarthroses, Post-traumatic arthritis
- Inclusion criteriao Operated between January 2000 and December 2004 o Completed the full follow up o Deceased with a known THA revision
- Exclusion criteriao Patients who did not completed the full follow up o Deceased without a known THA revision
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-mrt-2014
- planned closingdate31-dec-2015
- Target number of participants800
- InterventionsThe Anatomic Benoist Girard (ABG) THA is made of a titanium alloy and has an anatomical femoral shape with only proximal fixation, the femoral component can be coated with hydroxyapatite for uncemented fixation. In comparison to other femoral stems the ABG femoral stem has got a higher ‘shoulder’ for good contact and fixation on to the cancellous metaphyseal bone and a smaller diaphyseal region to avoid diaphyseal fixation. Due to this specific geometry the physiological load transfer in both the acetabulum and femur is simulated. Fixation of the femoral and acetabular component can be uncemented and cemented dependent on the surgeons experience or the intensity of the use of the THA. There is no difference in geometry of the uncemented and cemented femoral components
- Primary outcomeComparing the initial and long-term survival of the cemented and uncemented ABG prosthesis. The primary endpoint will be defined as revision of the ABG THA for any kind. Revision for prosthesis related reasons (RPR) will be defined as revision for mechanical aseptic loosening, wear of the implant, breakage or instability due to implant failure that required surgical arthroplasty of femoral or acetabulum components.
- Secondary outcomeComparing the initial and long-term clinical results of the cemented and uncemented ABG prosthesis. o Standard clinical parameters (Physical examination(2.4) and Questionnaires (2.5)) will be evaluated and compared between both groups.
- Timepoints>10years Follow up
- Trial web siteNA
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M.G.M. Schotanus
- CONTACT for SCIENTIFIC QUERIESDrs. M.G.M. Schotanus
- Sponsor/Initiator Orbis Medisch Centrum, Orthopedic Department
- Funding
(Source(s) of Monetary or Material Support)
Stichting ter bevordering van de orthopaedische kwaliteit
- Publications J Arthroplasty. 2015 Aug 29. pii: S0883-5403(15)00777-9. doi: 10.1016/j.arth.2015.08.023. [Epub ahead of print] Results of Cemented Anatomically Adapted Total Hip Arthroplasty: A Follow-Up Longer Than 10years. Heijnens LJ1, Schotanus MG1, Kort NP1, Verburg AD1, van Haaren EH1.
- Brief summaryTotal hip arthroplasty (THA) is often the end-stage treatment for severe osteoarthritis. Ageing and obesity are triggering factors for a higher number of patients with osteoarthritis. Osteoarthritis and overall joint pain is most located in the knees and hips. With the obesity and ageing in mind the incidence of a THA operation will be increasing, also in younger patients. Because of the younger aged patients who receive a THA the survival of the femoral component and articulations must be sufficient to give al long lasting quality of life and a minimal chance of revision of the THA. There are two major ways to implant a THA, uncemented and cemented. The use of uncemented THA is increasing over de last years, but there is till so far no superior method. The Anatomic Benoist Girard (ABG) THA is made of a titanium alloy and has an anatomical femoral shape with only proximal fixation, the femoral component can be coated with hydroxyapatite for uncemented fixation. In comparison to other femoral stems the ABG femoral stem has got a higher ‘shoulder’ for good contact and fixation on to the cancellous metaphyseal bone and a smaller diaphyseal region to avoid diaphyseal fixation. Due to this specific geometry the physiological load transfer in both the acetabulum and femur is simulated. Fixation of the femoral and acetabular component can be uncemented and cemented dependent on the surgeons experience or the intensity of the use of the THA. There is no difference in geometry of the uncemented and cemented femoral components. The ABG THA has been widely used from 1989 in Europe and is also investigated in several studies. The study of Nourissat et al. showed a survival with revision as endpoint of 97.6%. Nevertheless this was a study with a minimum 8-year follows up and had only investigated uncemented ABG THA. There are no studies comparing the long time follow up and survival, 10-years or more, of the uncemented and cemented ABG THA. This clinical study is a benefit for patients who receive an ABG THA, if the survival rate turns out to be good for both uncemented and the cemented ABG THA in comparison with other prostheses, it would justify further use of both types of the ABG THA.
- Main changes (audit trail)
- RECORD12-feb-2014 - 18-nov-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl