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

NCT ID: NCT00214760

Last Updated: 2010-02-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2011-09-30

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PGET

Group Type: EXPERIMENTAL

PGET

Intervention Type: DEVICE

resolbable liner

PMMA

Group Type: ACTIVE_COMPARATOR

PMMA

Intervention Type: DEVICE

cement liner

Interventions

PGET

resolbable liner

Intervention Type: DEVICE

PMMA

cement liner

Intervention Type: DEVICE

Other Intervention Names

resolbable liner; cement liner

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atrium Medical Center

OTHER

Sponsor Role: collaborator

Biomet Nederland BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Atrium medisch centrum

Principal Investigators

Joanne Bloemsaat-Minekus, PhD

Role: PRINCIPAL_INVESTIGATOR

Biomet Nederland

Locations

Atrium medical centre

Heerlen, , Netherlands

Countries

Netherlands

References

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. doi: 10.3928/0147-7447-19991101-13.

Reference Type: RESULT

PMID: 10580823 (View on PubMed)

Other Identifiers

BMBL_2005_01

Identifier Type: -

Identifier Source: org_study_id