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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 16, 2005

Last Updated Date

January 29, 2010

Start Date ^ICMJE

May 2005

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Alignment
Complications

Change History

Complete list of historical versions of study NCT00214760 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Pain
Function

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Osteoarthritis

Intervention ^ICMJE

Device: PGET
resolbable liner

Other Name: resolbable liner
Device: PMMA
cement liner

Other Name: cement liner

Study Arm (s)

Experimental: PGET
Intervention: Device: PGET
Active Comparator: PMMA
Intervention: Device: PMMA

Publications *

Hernández-Vaquero D, Murcia-Mazón A, Paz-Jimenez J, Alegre-Mateo R, Martínez-García 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.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

September 2011

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Netherlands

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00214760

Other Study ID Numbers ^ICMJE

BMBL_2005_01

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Meijers, Atrium medisch centrum

Study Sponsor ^ICMJE

Biomet Nederland BV

Collaborators ^ICMJE

Atrium Medical Center

Investigators ^ICMJE

Principal Investigator:

Joanne Bloemsaat-Minekus, PhD

Biomet Nederland

Information Provided By

Biomet Nederland BV

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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