Osteoarthritis Clinical Trial
Official title:
Phase 3 Randomised, Prospective Study Comparing the PMMA and the Resorbable PEGT/PBT Centralizer by the Uncemented BIHAPRO Total Hip Prosthesis
The purpose of this study is to analyse if the alignment of the stem and the number of complications of the new resorbable PEGT/PBT centralizer are comparable to the standard PMMA centralizer during the placement of an uncemented Bihapro hip prosthesis.
For a correct placement and early fixation of an uncemented hip prosthesis, a centralizer is
used. Normally, the centralizer is made of PMMA, the same material as bone cement. When a
revision is needed, PMMA is difficult to remove, which is one of the reason not to use a
cemented hip prosthesis. With a PMMA centralizer, still PMMA will remain in the bone and
needs to be removed in case of a revision. PEGT/PBT is a reabsorbable material, which gives
stability during the first month after the placement of the hip prosthesis. However,
PEGT/PBT is reabsorped afterwards and, therefore, will not interfere with a revision
procedure.
The goal of this study is to analyse if the PEGT/PBT is as safe as PMMA in terms of
alignment, direct postoperative complications and clinical results.
Therefore, 100 patients indicated for a cementless Bihapro hip prosthesis which have signed
an informed consent are included and randomised over the used centralizers using a weighted
randomisation method. All patients will be treated equally. The patients are examined
preoperatively, 1 day, 6 weeks, 3, 6, 12, 24 en 48 months postoperatively using an X-ray,
the Harris hip score and a patient questionnaire, the Womac and SF36.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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