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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis, Hip, Traumatic Arthritis of Hip

Intervention / Treatment
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* Device: Answer® hip stem
* Device: Answer® hip stem


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Answer® hip stem with Simplex Cement<br>Femoral stem replacement with Answer® hip stem & Simplex Bone Cement | Device: Answer® hip stem<br>* Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.<br>* Other names: Simplex Bone Cement;Device: Answer® hip stem<br>* Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.<br>* Other names: Palacos Bone Cement;|
| Active Comparator: Answer® hip stem with Palacos Cement<br>Femoral stem replacement with Answer® hip stem & Palacos Bone Cement | Device: Answer® hip stem<br>* Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.<br>* Other names: Simplex Bone Cement;Device: Answer® hip stem<br>* Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.<br>* Other names: Palacos Bone Cement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |