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Study was terminated due to insufficient data and lack of patient follow-up
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Answer® hip stem with Simplex Cement | Active Comparator | Femoral stem replacement with Answer® hip stem & Simplex Bone Cement |
|
| Answer® hip stem with Palacos Cement | Active Comparator | Femoral stem replacement with Answer® hip stem & Palacos Bone Cement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Answer® hip stem | Device | Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ken Beres, MD | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomet Orthopedics, LLC | Warsaw | Indiana | 46581 | United States |
The patients were assigned to each group according to the bone cement used with the implant.
Patients were recruited by the investigator based on the FDA cleared inclusion/exclusion criteria in the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Answer Stem Utilizing Simplex Cement | Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics |
| FG001 | Answer Stem Utilizing Palacos Cement | Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Operative |
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| 6 Months |
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| 1 Year |
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| 2 Years |
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| 4 Years |
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| 6 Years |
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| 8 Years |
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| 10 Years |
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| ID | Title | Description |
|---|---|---|
| BG000 | Answer Stem Utilizing Simplex Cement | Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics |
| BG001 | Answer Stem Utilizing Palacos Cement |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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." | This population represents patients that returned for follow-up per protocol. | Posted | Mean | Standard Deviation | Mean Hip Pain | Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year |
|
8 Years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Answer Stem Utilizing Simplex Cement | Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dislocation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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Study was terminated prematurely after sponsor no longer distributed the products involved and follow-up failed to produce sufficient data to be analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nick Higdon, Clinical Research Specialist | Biomet Manufacturing | 1-800-348-9500 | 3047 | nicholas.higdon@biomet.com |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Answer® hip stem | Device | Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation. |
|
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| 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." | This population represents patients that returned for follow-up per protocol. Because no patients returned at the primary outcome measure time frame (10 years), 0 patients were analyzed at 10 years. | Posted | 10 Years Post-Operative |
|
|
|
| 15 |
| 202 |
| 0 |
| 202 |
| EG001 | Answer Stem Utilizing Palacos Cement | Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation. | 8 | 200 | 0 | 200 |
| Femoral loosening | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Deep infection < 6 weeks | Infections and infestations | Non-systematic Assessment |
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| Deep infection > 6 weeks | Infections and infestations | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
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| Stroke | Vascular disorders | Non-systematic Assessment |
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| Femoral, acetabular loosening and instability | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Revision with all components removed and re-implantation | Surgical and medical procedures | Non-systematic Assessment |
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| I&D, exchange of poly liner | Surgical and medical procedures | Non-systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can conduct a pre-publication review of articles, papers, or presentations which the PI desires to publish. Any such review must be completed by sponsor within thirty (30)days of the submission of the request. The PI must include whatever credits the sponsor deems necessary or appropriate to disclose its proprietary interest to the material disclosed in the article, paper or presentation.
| D012216 |
| Rheumatic Diseases |