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

Tracking Information
First Submitted Date ICMJE	September 16, 2005
First Posted Date ICMJE	September 22, 2005
Last Update Posted Date	February 1, 2010
Study Start Date ICMJE	May 2005
Actual Primary Completion Date	August 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 29, 2010)	Alignment [ Time Frame: 0,3,6,12,24 months ]; Complications [ Time Frame: all time points ]
Original Primary Outcome Measures ICMJE; (submitted: September 16, 2005)	Alignment; Complications
Change History	Complete list of historical versions of study NCT00214760 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 29, 2010)	Pain [ Time Frame: 0,3,6,12,24 months ]; Function [ Time Frame: 0,3,6,12,24 months ]
Original Secondary Outcome Measures ICMJE; (submitted: September 16, 2005)	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; Intervention Model: Parallel Assignment; Masking: Single (Participant); 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 Arms	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
Actual Enrollment ICMJE; (submitted: January 29, 2010)	70
Original Enrollment ICMJE; (submitted: September 16, 2005)	100
Estimated Study Completion Date	September 2011
Actual 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	No
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	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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
PRS Account	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