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

Phase 3

Terminated

• Conditions: Osteoarthritis
• Interventions: Device: PGET; Device: PMMA

• Registration Number: NCT00214760
• Lead Sponsor: Biomet Nederland BV

Brief Summary

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.

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Primary Completion: 2008-08
• Status Verified: 2009-11
• Last Update Submitted: 2010-01-29
• Last Update Posted: 2010-02-01
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PGET	PGET	-
PMMA	PMMA	-

Primary Outcome Measures

Name	Time	Method
Complications	all time points
Alignment	0,3,6,12,24 months

Secondary Outcome Measures

Name	Time	Method
Pain	0,3,6,12,24 months
Function	0,3,6,12,24 months

Trial Locations

Locations (1)

Atrium medical centre; 🇳🇱 Heerlen, Netherlands