Polymethyl Methacrylate and (PEGT/PBT) Centralizer by the Uncemented BIHAPRO THP
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|ClinicalTrials.gov Identifier: NCT00214760|
Recruitment Status : Terminated (On of the liners has been taken from the market)
First Posted : September 22, 2005
Last Update Posted : February 1, 2010
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Device: PGET Device: PMMA||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase 3 Randomised, Prospective Study Comparing the PMMA and the Resorbable PEGT/PBT Centralizer by the Uncemented BIHAPRO Total Hip Prosthesis|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||August 2008|
|Estimated Study Completion Date :||September 2011|
Other Name: resolbable liner
|Active Comparator: PMMA||
Other Name: cement liner
- Alignment [ Time Frame: 0,3,6,12,24 months ]
- Complications [ Time Frame: all time points ]
- Pain [ Time Frame: 0,3,6,12,24 months ]
- Function [ Time Frame: 0,3,6,12,24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214760
|Atrium medical centre|
|Heerlen, Netherlands, 6401CX|
|Principal Investigator:||Joanne Bloemsaat-Minekus, PhD||Biomet Nederland|