Polymethyl Methacrylate and (PEGT/PBT) Centralizer by the Uncemented BIHAPRO THP
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Phase 3 Randomised, Prospective Study Comparing the PMMA and the Resorbable PEGT/PBT Centralizer by the Uncemented BIHAPRO Total Hip Prosthesis|
- Alignment [ Time Frame: 0,3,6,12,24 months ] [ Designated as safety issue: No ]
- Complications [ Time Frame: all time points ] [ Designated as safety issue: Yes ]
- Pain [ Time Frame: 0,3,6,12,24 months ] [ Designated as safety issue: No ]
- Function [ Time Frame: 0,3,6,12,24 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Estimated Study Completion Date:||September 2011|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Other Name: resolbable liner
|Active Comparator: PMMA||
Other Name: cement liner
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.
|Atrium medical centre|
|Heerlen, Netherlands, 6401CX|
|Principal Investigator:||Joanne Bloemsaat-Minekus, PhD||Biomet Nederland|