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

Sponsor:	Biomet Orthopedics, LLC
Information provided by (Responsible Party):	Biomet, Inc. ( Biomet Orthopedics, LLC )
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
Osteoarthritis, Hip Traumatic Arthritis of Hip	Device: Answer® hip stem

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

Resource links provided by NLM:

MedlinePlus related topics: Hip Replacement Osteoarthritis

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Harris Hip Score [ Time Frame: 10 Years Post-Operative ] [ Designated as safety issue: No ]
The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent." 80-89 is considered "Good." 70-79 is considered "Fair." Less than 70 is considered "Poor."

Secondary Outcome Measures:

Harris Hip Score Pain [ Time Frame: Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year ] [ Designated as safety issue: No ]
Harris Hip Score Pain is detailed below as mean score for the Harris Hip Score Pain question. 44 being the highest score, and 0 being the lowest score. 44 is considered "None/Ignores." 40 is considered "Slight/Occasional." 30 is considered "Mild." 20 is considered "Moderate." 10 is considered "Marked." 0 is considered "Totally Disabled."

Enrollment:	400
Study Start Date:	September 2002
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Answer Stem with Simplex Cement	Device: Answer® hip stem Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell. Other Names: Answer Hip Stem Simplex Bone Cement
Active Comparator: Answer Stem with Palacos Cement	Device: Answer® hip stem Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell. Other Names: Answer Hip Stem Palacos Bone Cement

Detailed Description:

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. It was desirable to see if there were any differences in the outcomes of two different types of bone cement in application.

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

Investigators

Study Director:

Ken Beres, MD

Biomet, Inc.

More Information

No publications provided

Responsible Party:	Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:	NCT00588861 History of Changes
Other Study ID Numbers:	101-U-011
Study First Received:	December 19, 2007
Results First Received:	June 14, 2010
Last Updated:	January 12, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Arthritis
Osteoarthritis
Osteoarthritis, Hip

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012