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

This study has been terminated.
(On of the liners has been taken from the market)
Atrium Medical Center
Information provided by:
Biomet Nederland BV Identifier:
First received: September 16, 2005
Last updated: January 29, 2010
Last verified: November 2009
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 Intervention Phase
Osteoarthritis Device: PGET Device: PMMA Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Biomet Nederland BV:

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

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

Enrollment: 70
Study Start Date: May 2005
Estimated Study Completion Date: September 2011
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PGET Device: PGET
resolbable liner
Other Name: resolbable liner
Active Comparator: PMMA Device: PMMA
cement liner
Other Name: cement liner

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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00214760

Atrium medical centre
Heerlen, Netherlands, 6401CX
Sponsors and Collaborators
Biomet Nederland BV
Atrium Medical Center
Principal Investigator: Joanne Bloemsaat-Minekus, PhD Biomet Nederland
  More Information

Responsible Party: Meijers, Atrium medisch centrum Identifier: NCT00214760     History of Changes
Other Study ID Numbers: BMBL_2005_01
Study First Received: September 16, 2005
Last Updated: January 29, 2010

Keywords provided by Biomet Nederland BV:
Hip prosthesis

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Polymethyl Methacrylate
Vasodilator Agents
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs processed this record on September 21, 2017