Arthropathy of Hip Joint, Osteoarthritis, Hip
Conditions
Brief summary
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.
Detailed description
Methods: Data Collection: * pre-op assessment/physical therapy evaluation * post op assessment - PACU, phase II (Prior to discharge) * phone calls after discharge (post op day 1, 2, 3) * follow up assessment in surgeon's office (3 and 6 weeks post op) * Ortech * Swiftpath * HOOS jr Pre-optimization: * All patients enroll in SwiftPath education program * Optimized BMI, hemoglobin, albumin, glucose control, A1C and blood pressure control Total Joint procedure: -anterior approach using the HANA table THA preformed with intra-articular block Pain Management regimen: * Pre op PT teaching * post op multimodal pain regimen
Interventions
None listed
Sponsors
St. Elizabeth Medical Center, Utica, NY
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Elective total hip arthroplasty * unilateral * patient surgeries scheduled to be performed at the hospital and surgery center * patients must enroll in SwiftPath * Ability to read and understand English
Exclusion criteria
* Patient diagnosis of schizophrenia, bipolar disease, dementia * previous burn to affected extremity * BMI \> 40 * Hemoglobin \<12 female, \<13 male * Albumin less than 3.5 * A1C \>8.0
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-operative Narcotic Use | Pre-operatively | Percentage of patients that used used opioids pre-operatively |
| Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period | 6 weeks | Number of patients that took any opioids throughout 6-week follow-up period |
| Short Physical Performance Battery | 6 Weeks | Assessment tool measuring gait speed, balance and chair stand test. Scores range from 0 to 4 with higher scores indicating a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay in Hospital | 1 week | Average number of days in hospital after surgery |
| Numeric Pain Scores | 6 Weeks | 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. |
| Number of Patients Who Return to Driving 6 Weeks After Surgery | 6 Weeks | Patients will respond yes or no when asked if they have resumed driving. |
| Number of Patients That Return to Work 6 Weeks After Surgery | 6 weeks | 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. |
| Sleep Quality | 6 Weeks | The percentage of patients where pain interrupts sleep 'never' or 'rarely' will be combined together and reported. |
| Number of Participants Who Adhere to Prescribed Post op Recovery Protocol | 2 weeks | Number of Participants Who Adhere to Prescribed Post op Recovery Protocol collected via a questionnaire |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| THR With HANA Table Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table. | 207 |
| Total | 207 |
Baseline characteristics
| Characteristic | THR With HANA Table |
|---|---|
| Age, Continuous | 68.7 years STANDARD_DEVIATION 9.75 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 202 Participants |
| Region of Enrollment United States | 207 participants |
| Sex: Female, Male Female | 116 Participants |
| Sex: Female, Male Male | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 207 |
| other Total, other adverse events | 0 / 207 |
| serious Total, serious adverse events | 0 / 207 |
Outcome results
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
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THR With HANA Table | Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period | 128 Participants |
Primary
Pre-operative Narcotic Use
Percentage of patients that used used opioids pre-operatively
Time frame: Pre-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THR With HANA Table | Pre-operative Narcotic Use | 30 Participants |
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.
Time frame: 6 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THR With HANA Table | Short Physical Performance Battery | Balance | 3.95 score on a scale | Standard Deviation 0.31 |
| THR With HANA Table | Short Physical Performance Battery | Gait | 3.89 score on a scale | Standard Deviation 0.45 |
| THR With HANA Table | Short Physical Performance Battery | Chair | 3.17 score on a scale | Standard Deviation 1.31 |
Secondary
Length of Stay in Hospital
Average number of days in hospital after surgery
Time frame: 1 week
| Arm | Measure | Value (MEAN) |
|---|---|---|
| THR With HANA Table | Length of Stay in Hospital | 0.4175 days |
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
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THR With HANA Table | Number of Participants Who Adhere to Prescribed Post op Recovery Protocol | 206 Participants |
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.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THR With HANA Table | Number of Patients That Return to Work 6 Weeks After Surgery | 56 Participants |
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.
Time frame: 6 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THR With HANA Table | Number of Patients Who Return to Driving 6 Weeks After Surgery | 182 Participants |
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.
Time frame: 6 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THR With HANA Table | Numeric Pain Scores | Best pain level | 0.00966 units on a scale | Standard Deviation 0.139 |
| THR With HANA Table | Numeric Pain Scores | Worst pain level | 2.14 units on a scale | Standard Deviation 1.77 |
Secondary
Sleep Quality
The percentage of patients where pain interrupts sleep 'never' or 'rarely' will be combined together and reported.
Time frame: 6 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THR With HANA Table | Sleep Quality | 184 Participants |