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To prove that anterior approach total hip arthroplasty using the HANA table can be performed with little, if any, need for opioids using a combination of education, optimized pre op and post op pain protocols and optimized recovery tools.
Methods:
Data Collection:
Pre-optimization:
Total Joint procedure:
-anterior approach using the HANA table THA preformed with intra-articular block
Pain Management regimen:
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| Measure | Description | Time Frame |
|---|---|---|
| Pre-operative Narcotic Use | Percentage of patients that used used opioids pre-operatively | Pre-operatively |
| Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period | Number of patients that took any opioids throughout 6-week follow-up period | 6 weeks |
| Short Physical Performance Battery | Assessment tool measuring gait speed, balance and chair stand test. Scores range from 0 to 4 with higher scores indicating a better outcome. | 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Scores | A numeric pain score (0-10, 0 is no pain and 10 is worst imaginable pain). This will be used to assess patients level of pain relating to opioid use and recovery. Both 'best' pain level and 'worst' pain level as reported by the patient will be reported. | 6 Weeks |
| Sleep Quality |
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Inclusion Criteria:
Exclusion Criteria:
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Males and females presenting seeking elective unilateral total hip arthoplasty that fall within inclusion criteria listed above
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Wickline, MD | St. Elizabeth's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Elizabeth's Medical Center | Utica | New York | 13501 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | THR With HANA Table | Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | THR With HANA Table | Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pre-operative Narcotic Use | Percentage of patients that used used opioids pre-operatively | Posted | Count of Participants | Participants | Pre-operatively |
|
|
1 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 | THR With HANA Table | Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Wickline, MD | Genesee Orthopedic & Hand Surgery Associates, P.C. | 315-735-4496 | awickline23@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2020 | Mar 13, 2020 | Prot_SAP_000.pdf |
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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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The percentage of patients where pain interrupts sleep 'never' or 'rarely' will be combined together and reported. |
| 6 Weeks |
| Number of Participants Who Adhere to Prescribed Post op Recovery Protocol | Number of Participants Who Adhere to Prescribed Post op Recovery Protocol collected via a questionnaire | 2 weeks |
| Length of Stay in Hospital | Average number of days in hospital after surgery | 1 week |
| Number of Patients That Return to Work 6 Weeks After Surgery | questionnaire asking the patient to report whether or not they have returned to employment and at what capacity (using Department of Labor physical employment scale). Patients will answer "yes" or "no" when asked if they have returned to work. | 6 weeks |
| Number of Patients Who Return to Driving 6 Weeks After Surgery | Patients will respond yes or no when asked if they have resumed driving. | 6 Weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period | Number of patients that took any opioids throughout 6-week follow-up period | Posted | Count of Participants | Participants | 6 weeks |
|
|
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| Primary | Short Physical Performance Battery | Assessment tool measuring gait speed, balance and chair stand test. Scores range from 0 to 4 with higher scores indicating a better outcome. | Posted | Mean | Standard Deviation | score on a scale | 6 Weeks |
|
|
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| Secondary | Numeric Pain Scores | A numeric pain score (0-10, 0 is no pain and 10 is worst imaginable pain). This will be used to assess patients level of pain relating to opioid use and recovery. Both 'best' pain level and 'worst' pain level as reported by the patient will be reported. | Posted | Mean | Standard Deviation | units on a scale | 6 Weeks |
|
|
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| Secondary | Sleep Quality | The percentage of patients where pain interrupts sleep 'never' or 'rarely' will be combined together and reported. | Posted | Count of Participants | Participants | 6 Weeks |
|
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| Secondary | Number of Participants Who Adhere to Prescribed Post op Recovery Protocol | Number of Participants Who Adhere to Prescribed Post op Recovery Protocol collected via a questionnaire | Posted | Count of Participants | Participants | 2 weeks |
|
|
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| Secondary | Length of Stay in Hospital | Average number of days in hospital after surgery | Posted | Mean | Full Range | days | 1 week |
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| Secondary | Number of Patients That Return to Work 6 Weeks After Surgery | questionnaire asking the patient to report whether or not they have returned to employment and at what capacity (using Department of Labor physical employment scale). Patients will answer "yes" or "no" when asked if they have returned to work. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | Number of Patients Who Return to Driving 6 Weeks After Surgery | Patients will respond yes or no when asked if they have resumed driving. | Posted | Count of Participants | Participants | 6 Weeks |
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| 0 |
| 207 |
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| 207 |
| 0 |
| 207 |
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| D012216 |
| Rheumatic Diseases |
|