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Polymethyl Methacrylate and (PEGT/PBT) Centralizer by the Uncemented BIHAPRO THP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Atrium Medical Center
Information provided by:
Biomet Nederland BV

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: PGET Device: PMMA Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : May 2005
Actual Primary Completion Date : August 2008
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PGET Device: PGET
resolbable liner
Other Name: resolbable liner

Active Comparator: PMMA Device: PMMA
cement liner
Other Name: cement liner

Primary Outcome Measures :
  1. Alignment [ Time Frame: 0,3,6,12,24 months ]
  2. Complications [ Time Frame: all time points ]

Secondary Outcome Measures :
  1. Pain [ Time Frame: 0,3,6,12,24 months ]
  2. Function [ Time Frame: 0,3,6,12,24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age between 18 and 75 years
  • Diagnosis: Osteoarthritis
  • Indicated for a primary hip prosthesis

Exclusion Criteria:

  • Previous hip surgery
  • No informed consent
  • Active infection in hip
  • Immature skeleton
  • Rheumatoid arthritis, M. Paget

Information from the National Library of Medicine

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 identifier (NCT number): NCT00214760

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Atrium medical centre
Heerlen, Netherlands, 6401CX
Sponsors and Collaborators
Biomet Nederland BV
Atrium Medical Center
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Principal Investigator: Joanne Bloemsaat-Minekus, PhD Biomet Nederland
Publications of Results:
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Responsible Party: Meijers, Atrium medisch centrum Identifier: NCT00214760    
Other Study ID Numbers: BMBL_2005_01
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 1, 2010
Last Verified: November 2009
Keywords provided by Biomet Nederland BV:
Hip prosthesis
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases