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| Name | Class |
|---|---|
| DJO Incorporated | INDUSTRY |
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The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the Revelation Hip Stem prior to 2002.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revelation | Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revelation Hip Stem (Revelation) | Device | Subjects who received the Revelation Hip Stem prior to 2002 and still maintain the original device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship of the Device | The subject meets the inclusion/exclusion criteria of the study and received a Revelation Hip Stem prior to 2002 that has survived intact without any type of surgery to revise or remove parts or the whole prosthesis. | 10 year |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario McMaster Arthritis Index (WOMAC) | Standardized questionnaire used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. It assesses the pain, joint stiffness, physical, social & emotional function of a person with osteoarthritis in determining the overall level of disability. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). For each item, the possible range of scores is therefore 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include only subjects who received the Revelation Hip Stem prior to 2002 and who voluntarily consent to take part in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Frosty Moore, M.D. | Westlake Orthopaedics Spine & Sports | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westlake Orthopaedics Spine & Sports | Austin | Texas | 78746 | United States |
Assignment was based on subjects signing the consent form. They were either in the study or not.
The site had a list of patients to call based on previous enrollment into an IDE study from back in 1998. There was not additional recruitment required.
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| ID | Title | Description |
|---|---|---|
| FG000 | Revelation | Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Revelation | Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survivorship of the Device | The subject meets the inclusion/exclusion criteria of the study and received a Revelation Hip Stem prior to 2002 that has survived intact without any type of surgery to revise or remove parts or the whole prosthesis. | Subjects who signed the consent form and completed the study paperwork. | Posted | Number | participants | 10 year |
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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 | Revelation | Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit. |
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Small patient population to choose from and difficulty in locating people who have not been seen by the doctor in almost 10 years.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jane M. Jacob | DJO Surgical | 512-834-6323 | jane.jacob@djoglobal.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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| 10 year |
| Harris Hip Score | A tool for the evaluation of how a patient is doing after their hip is replaced. Based on a total of 100 points possible, each question is awarded a certain number of points based on how it is answered. Questions are further grouped into four categories. The first category is pain, the second category is function, third is functional activities and finally the physical exam results are tabulated, and based on your range of motion. The score is reported as 90-100 for excellent results, 80-90 being good, 70-79 fair, 60-69 poor, and below 60 a failed result. | 10 year |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Western Ontario McMaster Arthritis Index (WOMAC) | Standardized questionnaire used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. It assesses the pain, joint stiffness, physical, social & emotional function of a person with osteoarthritis in determining the overall level of disability. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). For each item, the possible range of scores is therefore 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. | Posted | Mean | Standard Deviation | units on a scale | 10 year |
|
|
|
| Secondary | Harris Hip Score | A tool for the evaluation of how a patient is doing after their hip is replaced. Based on a total of 100 points possible, each question is awarded a certain number of points based on how it is answered. Questions are further grouped into four categories. The first category is pain, the second category is function, third is functional activities and finally the physical exam results are tabulated, and based on your range of motion. The score is reported as 90-100 for excellent results, 80-90 being good, 70-79 fair, 60-69 poor, and below 60 a failed result. | Posted | Mean | Standard Deviation | units on a scale | 10 year |
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| 0 |
| 8 |
| 0 |
| 8 |
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| D012216 |
| Rheumatic Diseases |