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

Not Applicable

Terminated

• Conditions: Osteoarthritis, Hip; Traumatic Arthritis of Hip
• Interventions: Device: Answer® hip stem

• Registration Number: NCT00588861
• Lead Sponsor: Biomet Orthopedics, LLC

Brief Summary

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.

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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2008-01-02
• Study First Posted: 2008-01-09
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2010-06-14
• Status Verified: 2012-01
• Results First Submitted QC: 2012-01-12
• Results First Posted: 2012-01-26
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Answer® hip stem with Palacos Cement	Answer® hip stem	Femoral stem replacement with Answer® hip stem \& Palacos Bone Cement
Answer® hip stem with Simplex Cement	Answer® hip stem	Femoral stem replacement with Answer® hip stem \& Simplex Bone Cement

Primary Outcome Measures

Name	Time	Method
Harris Hip Score	10 Years Post-Operative	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

Name	Time	Method
Harris Hip Score Pain	Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year	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."

Trial Locations

Locations (1)

Biomet Orthopedics, LLC; 🇺🇸 Warsaw, Indiana, United States