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| Sponsor: | Biomet Nederland BV |
|---|---|
| Collaborator: |
Atrium Medical Center |
| Information provided by: | Biomet Nederland BV |
| ClinicalTrials.gov Identifier: | NCT00214760 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Device: PGET Device: PMMA |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase 3 Randomised, Prospective Study Comparing the PMMA and the Resorbable PEGT/PBT Centralizer by the Uncemented BIHAPRO Total Hip Prosthesis |
| Enrollment: | 70 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | September 2011 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| PGET: Experimental |
Device: PGET
resolbable liner
|
| PMMA: Active Comparator |
Device: PMMA
cement liner
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands | |
| Atrium medical centre | |
| Heerlen, Netherlands, 6401CX | |
| Principal Investigator: | Joanne Bloemsaat-Minekus, PhD | Biomet Nederland |
More Information
| Responsible Party: | Atrium medisch centrum ( Meijers ) |
| Study ID Numbers: | BMBL_2005_01 |
| Study First Received: | September 16, 2005 |
| Last Updated: | January 29, 2010 |
| ClinicalTrials.gov Identifier: | NCT00214760 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
Hip prosthesis Centralizer Uncemented |
|
Vasodilator Agents Osteoarthritis Joint Diseases Physiological Effects of Drugs Antimutagenic Agents Rheumatic Diseases Cardiovascular Agents |
Protective Agents Pharmacologic Actions Polymethyl Methacrylate Musculoskeletal Diseases Arthritis Therapeutic Uses |
