Comparing the PMMA and PEGT/PBT Centralizer by the Uncemented BIHAPRO Total Hip Prosthesis - Full Text View

Sponsored by:	Biomet Nederland BV
Information provided by:	Biomet Nederland BV
ClinicalTrials.gov Identifier:	NCT00214760

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: Bihapro Hip prosthesis	Phase III

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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
Complications

Secondary Outcome Measures:

Pain
Function

Estimated Enrollment:	100
Study Start Date:	May 2005
Estimated Study Completion Date:	September 2005

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 resorbable material, which gives stability during the first month after the placement of the hip prosthesis. However, PEGT/PBT is resorped 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	Recruiting
Heerlen, Netherlands, 6401CX
Contact: WGH Meijers, MD +31 045 527 99 99 wghmeij@planet.nl
Principal Investigator: Wil Meijers, MD

Sponsors and Collaborators

Biomet Nederland BV

Investigators

Principal Investigator:

Joanne Bloemsaat-Minekus, PhD

Biomet Nederland

More Information

Publications of Results:

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.

Study ID Numbers:	BMBL_2005_01
Study First Received:	September 16, 2005
Last Updated:	December 7, 2005
ClinicalTrials.gov Identifier:	NCT00214760
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Biomet Nederland BV:

Hip prosthesis
Centralizer
Uncemented

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 14, 2009