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)
Sponsor:
Collaborator:
Atrium Medical Center
Information provided by:
Biomet Nederland BV
ClinicalTrials.gov Identifier:
NCT00214760
First received: September 16, 2005
Last updated: January 29, 2010
Last verified: November 2009

September 16, 2005
January 29, 2010
May 2005
August 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Alignment
  • Complications
Complete list of historical versions of study NCT00214760 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Osteoarthritis
  • 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
Hernandez-Vaquero D, Murcia-Mazon A, Paz-Jimenez J, Alegre-Mateo R, Martinez-Garcia 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
70
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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00214760
BMBL_2005_01
No
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