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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Biomet Nederland BV:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214760

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

Publications:
Responsible Party: Meijers, Atrium medisch centrum
ClinicalTrials.gov Identifier: NCT00214760     History of Changes
Other Study ID Numbers: BMBL_2005_01
Study First Received: September 16, 2005
Last Updated: January 29, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Biomet Nederland BV:
Hip prosthesis
Centralizer
Uncemented

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Polymethyl Methacrylate
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014