Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement

This study has been terminated.

First Received: December 19, 2007 Last Updated: December 1, 2009 History of Changes

Sponsor:	Biomet Orthopedics, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00588861

Purpose

The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement.

Condition	Intervention
Degenerative Joint (Hip) Disease Arthritis of the Hip Joint	Device: Answer® hip stem

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment
Official Title:	Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Acetabular Shell Using Simplex® or Palacos® Bone Cement

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Clinical outcomes including Harris Hip Score [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Harris Hip Score Pain [ Time Frame: Pre-op, 6 months, 1yr, 2yr, 4yr, 6yr, 8yr, 10yr ] [ Designated as safety issue: No ]

Enrollment:	400
Study Start Date:	September 2002
Estimated Study Completion Date:	September 2016
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Device: Answer® hip stem Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
2: Active Comparator	Device: Answer® hip stem Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

Exclusion Criteria:

Infection, sepsis, and osteomyelitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588861

Locations

United States, Indiana
Biomet Orthopedics, LLC
Warsaw, Indiana, United States, 46581

Sponsors and Collaborators

Biomet Orthopedics, LLC

More Information

No publications provided

Responsible Party:	Biomet Orthopedics, LLC ( Kenneth J. Beres, Director of Clinical Research )
Study ID Numbers:	101-U-011
Study First Received:	December 19, 2007
Last Updated:	December 1, 2009
ClinicalTrials.gov Identifier:	NCT00588861 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Musculoskeletal Diseases
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on February 08, 2010