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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00214760
• Other study ID #: BMBL_2005_01
• Status: Terminated
• Phase: Phase 3
• First received: September 16, 2005
• Last updated: January 29, 2010
• Start date: May 2005
• Est. completion date: September 2011

Study information

• Verified date: November 2009
• Source: Biomet Nederland BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: September 2011
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• PGET
resolbable liner
• PMMA
cement liner

Locations

Country	Name	City	State
Netherlands	Atrium medical centre	Heerlen

Sponsors (2)

Lead Sponsor	Collaborator
Biomet Nederland BV	Atrium Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alignment		0,3,6,12,24 months	No
Primary	Complications		all time points	Yes
Secondary	Pain		0,3,6,12,24 months	No
Secondary	Function		0,3,6,12,24 months	No