Study Stopped
Study was terminated due to insufficient data and lack of patient follow-up
Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 19, 2007
CompletedFirst Posted
Study publicly available on registry
January 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
January 26, 2012
CompletedJanuary 27, 2017
January 1, 2012
7.7 years
December 19, 2007
June 14, 2010
January 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Harris Hip Score Pain
Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year
Study Arms (2)
Answer® hip stem with Simplex Cement
ACTIVE COMPARATORFemoral stem replacement with Answer® hip stem \& Simplex Bone Cement
Answer® hip stem with Palacos Cement
ACTIVE COMPARATORFemoral stem replacement with Answer® hip stem \& Palacos Bone Cement
Interventions
Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Infection, sepsis, and osteomyelitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Biomet Orthopedics, LLC
Warsaw, Indiana, 46581, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study was terminated prematurely after sponsor no longer distributed the products involved and follow-up failed to produce sufficient data to be analyzed.
Results Point of Contact
- Title
- Nick Higdon, Clinical Research Specialist
- Organization
- Biomet Manufacturing
Study Officials
- STUDY DIRECTOR
Ken Beres, MD
Zimmer Biomet
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2007
First Posted
January 9, 2008
Study Start
September 1, 2002
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
January 27, 2017
Results First Posted
January 26, 2012
Record last verified: 2012-01