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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00588861
• Other study ID #: 101-U-011
• Status: Terminated
• Phase: N/A
• First received: December 19, 2007
• Last updated: January 26, 2017
• Start date: September 2002
• Est. completion date: May 2010

Study information

• Verified date: January 2012
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Traumatic Arthritis of Hip

Intervention

Device:
• Answer® hip stem
Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
• Answer® hip stem
Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.

Locations

Country	Name	City	State
United States	Biomet Orthopedics, LLC	Warsaw	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Biomet Orthopedics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score	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."	10 Years Post-Operative
Secondary	Harris Hip Score Pain	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."	Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year