Comparing the PMMA and PEGT/PBT Centralizer by the Uncemented BIHAPRO Total Hip Prosthesis

Condition(s) targeted: Osteoarthritis

Intervention: Bihapro Hip prosthesis (Device)

Phase: Phase 3

Status: Recruiting

Sponsored by: Biomet Nederland BV

Official(s) and/or principal investigator(s):
Joanne Bloemsaat-Minekus, PhD, Principal Investigator, Affiliation: Biomet Nederland

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.

Official title: Phase 3 Randomised, Prospective Study Comparing the PMMA and the Resorbable PEGT/PBT Centralizer by the Uncemented BIHAPRO Total Hip Prosthesis

Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Alignment

Complications

Secondary outcome:

Pain

Function

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Atrium medical centre, Heerlen 6401CX, Netherlands; Recruiting
WGH Meijers, MD, Phone: +31 045 527 99 99, Email: wghmeij@planet.nl
Wil Meijers, MD, Principal Investigator

Starting date: May 2005
Ending date: September 2005
Last updated: December 7, 2005