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

September 16, 2005
September 22, 2005
February 1, 2010
May 2005
August 2008   (Final data collection date for primary outcome measure)
  • Alignment [ Time Frame: 0,3,6,12,24 months ]
  • Complications [ Time Frame: all time points ]
  • Alignment
  • Complications
Complete list of historical versions of study NCT00214760 on Archive Site
  • Pain [ Time Frame: 0,3,6,12,24 months ]
  • Function [ Time Frame: 0,3,6,12,24 months ]
  • Pain
  • Function
Not Provided
Not Provided
Polymethyl Methacrylate and (PEGT/PBT) Centralizer by the Uncemented BIHAPRO THP
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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Device: PGET
    resolbable liner
    Other Name: resolbable liner
  • Device: PMMA
    cement liner
    Other Name: cement liner
  • Experimental: PGET
    Intervention: Device: PGET
  • Active Comparator: PMMA
    Intervention: Device: PMMA
Hernández-Vaquero D, Murcia-Mazón A, Paz-Jimenez J, Alegre-Mateo R, Martínez-García J, Pena-Vazquez J. Behavior of the femoral stem in the Bihapro hip prosthesis. Orthopedics. 1999 Nov;22(11):1049-53.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2011
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Meijers, Atrium medisch centrum
Biomet Nederland BV
Atrium Medical Center
Principal Investigator: Joanne Bloemsaat-Minekus, PhD Biomet Nederland
Biomet Nederland BV
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP