Arthropathy of Knee Joint
Conditions
Brief summary
To prove that total knee arthroplasty can be performed with little, if any need for opioids by using a combination of patient education, optimized pre-op and post-op pain and recovery protocols. The goal being opioid-free total knee arthroplasty.
Detailed description
All study patients will receive a standardized protocol * All surgical procedures performed by single surgeon using same implants, approach, pre-op and post-op optimization, and simplified pain protocol at a single hospital or surgery center * Will attempt to minimize the number of anesthesiologists to further control variability in care Methods: 1. Pre-op Optimization * All patients enroll in education program * All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C, and blood pressure 2. Total Joint Procedure * Tourniquet-free cemented total knee arthroplasty is performed with intra-articular block 3. Data Collection * Electronic medical record chart review * Pre-op assessment and Post-op assessment (post anesthesia care unit (PACU), Phase II-prior to discharge * Phone calls after discharge * Follow-up assessment in surgeon's office * Swift path / KOOS JR surveys 4. Pain Management Regimen * pre-op physical therapy teaching * post-op multimodal pain regimen
Interventions
dosage frequency and duration
Sponsors
Study design
Eligibility
Inclusion criteria
* Surgeries to be performed at hospital * Surgeries to be performed at surgery center * Ability to read and understand English * Primary care clearance for patients diagnosed with high blood pressure
Exclusion criteria
* Disease states, patient conditions to exclude: Schizophrenia Bipolar Disease Dementia * Known allergies to local anesthetics * Previous burn to affected extremity * BMI \> 40 * Nonoptimized anemia * Albumin less than 3.5 * A1C \> 8.0
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative | 12 weeks | Using a combination of patient education, optimized pre-operative and post-operative pain protocols and optimized recovery protocols |
| Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative | 12 weeks | The total number of opioid tablets taken by patient after total knee arthroplasty performed through 12 weeks postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement | 6 weeks | Swift path is an Educational tool (diary) for patients undergoing total joint replacement, that patients follow from the initial booking of surgery through their recovery. It guides patients through potential risks involved with joint surgery, through a multimodal pain management protocol for pain prevention and through recovery. |
| Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14 | Postop Days10-14 | Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals. |
| Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | postoperative days 1,2,3,postoperative day 10-14, 3 weeks post surgery, 6 weeks post surgery and 12 weeks post surgery | Pain level is measured by the Numerical Rating Scale (NRS) for pain utilizing minimum number 0 to maximum number 10 (0 represents no pain and 10 represents worst pain imaginable). The higher the number reported the worst the pain/outcome. This will be used to assess patient's level of pain relating to opioid use and recovery. |
| Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6 | Postoperative 6 weeks | Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals. |
| Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12 | Postoperative 12 weeks | Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals. |
| Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3 | postoperative 3 weeks | Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals. |
| Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) | Baseline (preoperative); 6 weeks post surgery; 12 weeks post surgery | The Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) is a survey that is an assessment and questionnaire that rates a patients joint pain, stiffness and function in daily living. Patients answer questions about joint stiffness, pain and daily activities using the following scoring values: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The values for all questions are added up to get a raw score that ranges from a minimum of 0 to a maximum of 28. This raw score is converted to an interval score using a provided table. The interval score ranges from a minimum of 0 to a maximum of 100 where 0 = total knee disability and 100 = perfect knee health. The higher the score on scale from 0 to 100 the better the outcome. |
Countries
United States
Participant flow
Recruitment details
All patients to have total knee arthroplasty. All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C and blood pressure. All patients enrolled in educational program. All patients have pre-op physical therapy teaching.
Participants by arm
| Arm | Count |
|---|---|
| Total Knee Arthroplasty Number of patients that had total knee arthroplasty after meeting study inclusion criteria | 386 |
| Total | 386 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Physician Decision | 6 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Total Knee Arthroplasty | — |
|---|---|---|
| Age, Continuous | 69 years | — |
| ASA I | 8 participants | — |
| ASA II | 173 participants | — |
| ASA III | 200 participants | — |
| ASA IV | 5 participants | — |
| BMI | 31.6 kg/m² STANDARD_DEVIATION 5.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 226 Participants | — |
| Sex: Female, Male Male | 160 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 386 |
| other Total, other adverse events | 33 / 386 |
| serious Total, serious adverse events | 4 / 386 |
Outcome results
Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative
The total number of opioid tablets taken by patient after total knee arthroplasty performed through 12 weeks postoperative
Time frame: 12 weeks
Population: Number of Participants Stratified by Total Quantity of Opioid Tablets Taken Post Total Knee Replacement
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Knee Arthoplasty | Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative | no opioids | 72 Participants |
| Total Knee Arthoplasty | Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative | 1-5 tablets | 159 Participants |
| Total Knee Arthoplasty | Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative | 6-10 tablets | 101 Participants |
| Total Knee Arthoplasty | Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative | >10 tablets | 53 Participants |
Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative
Using a combination of patient education, optimized pre-operative and post-operative pain protocols and optimized recovery protocols
Time frame: 12 weeks
Population: Number of patents that took no opioids after total knee arthroplasty 12 weeks post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Knee Arthoplasty | Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative | 73 Participants |
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity
Pain level is measured by the Numerical Rating Scale (NRS) for pain utilizing minimum number 0 to maximum number 10 (0 represents no pain and 10 represents worst pain imaginable). The higher the number reported the worst the pain/outcome. This will be used to assess patient's level of pain relating to opioid use and recovery.
Time frame: postoperative days 1,2,3,postoperative day 10-14, 3 weeks post surgery, 6 weeks post surgery and 12 weeks post surgery
Population: 386 patients analyzed through 6 weeks; 340 patients analyzed at 12 weeks only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Week 3- Best with Activity | 1.3 score on a scale | Standard Deviation 1.6 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Week 3 - Worst with Activity | 3.1 score on a scale | Standard Deviation 2.1 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Week 6 - Best at Rest | 0.1 score on a scale | Standard Deviation 0.6 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Week 12 - Best at Rest | 0.0 score on a scale | Standard Deviation 0.2 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Day 1 - Best with Rest | 1.0 score on a scale | Standard Deviation 1.8 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Day 1 - Worst with Rest | 2.4 score on a scale | Standard Deviation 2.3 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Day 1 - Best with Activity | 2.9 score on a scale | Standard Deviation 2.2 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Day 1 - Worst with Activity | 4.6 score on a scale | Standard Deviation 2.3 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Day 2 - Best at Rest | 1.8 score on a scale | Standard Deviation 2 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Day 2 - Worst at Rest | 3.4 score on a scale | Standard Deviation 2.3 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Day 2 - Best with Activity | 4.2 score on a scale | Standard Deviation 2 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Day 2 - Worst with Activity | 5.9 score on a scale | Standard Deviation 1.9 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Day 3 - Best at Rest | 1.0 score on a scale | Standard Deviation 1.6 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Day 3 - Worst at Rest | 2.4 score on a scale | Standard Deviation 2.1 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Day 3 - Best with Activity | 3.3 score on a scale | Standard Deviation 2.1 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Day 3 - Worst with Activity | 5.0 score on a scale | Standard Deviation 2 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Days 10-14 - Best at Rest | 0.5 score on a scale | Standard Deviation 1.2 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Days 10-14 - Worst at Rest | 2.1 score on a scale | Standard Deviation 2 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Days 10-14 - Best with Activity | 2.0 score on a scale | Standard Deviation 1.9 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Days 10-14 Worst with Activity | 4.0 score on a scale | Standard Deviation 2.1 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Week 3 - Best at Rest | 0.3 score on a scale | Standard Deviation 0.8 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Week 3 - Worst at Rest | 1.5 score on a scale | Standard Deviation 1.9 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Week 6 - Worst at Rest | 0.7 score on a scale | Standard Deviation 1.5 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Week 6 - Best with Activity | 0.5 score on a scale | Standard Deviation 1.2 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Week 6 - Worst with Activity | 1.9 score on a scale | Standard Deviation 2 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Week 12 - Worst at Rest | 0.2 score on a scale | Standard Deviation 0.7 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Week 12 - Best with Activity | 0.0 score on a scale | Standard Deviation 0.3 |
| Total Knee Arthoplasty | Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity | Postoperative Week 12 - Worst with Activity | 0.5 score on a scale | Standard Deviation 1.2 |
Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR)
The Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) is a survey that is an assessment and questionnaire that rates a patients joint pain, stiffness and function in daily living. Patients answer questions about joint stiffness, pain and daily activities using the following scoring values: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The values for all questions are added up to get a raw score that ranges from a minimum of 0 to a maximum of 28. This raw score is converted to an interval score using a provided table. The interval score ranges from a minimum of 0 to a maximum of 100 where 0 = total knee disability and 100 = perfect knee health. The higher the score on scale from 0 to 100 the better the outcome.
Time frame: Baseline (preoperative); 6 weeks post surgery; 12 weeks post surgery
Population: 311 patients reported KOOS JR scores at baseline which was prior to surgery. At 6 weeks 379 patients reported scores. At 12 weeks 341 patients reported scores.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Knee Arthoplasty | Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) | Baseline prior to surgery | 53.1 score on a scale | Standard Deviation 11.9 |
| Total Knee Arthoplasty | Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) | Postoperative 6 Week | 71.8 score on a scale | Standard Deviation 11.8 |
| Total Knee Arthoplasty | Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) | Postoperative 12 Week | 90.0 score on a scale | Standard Deviation 8.2 |
Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement
Swift path is an Educational tool (diary) for patients undergoing total joint replacement, that patients follow from the initial booking of surgery through their recovery. It guides patients through potential risks involved with joint surgery, through a multimodal pain management protocol for pain prevention and through recovery.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Knee Arthoplasty | Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement | 386 Participants |
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14
Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.
Time frame: Postop Days10-14
Population: Physical therapy adherence for patients not taking opioids and taking opioids at 10-14 day follow-up visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Knee Arthoplasty | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14 | PT Adherence | 193 Participants |
| Total Knee Arthoplasty | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14 | PT Non-adherence | 76 Participants |
| Opiates and Physical Therapy Adherence | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14 | PT Adherence | 64 Participants |
| Opiates and Physical Therapy Adherence | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14 | PT Non-adherence | 53 Participants |
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3
Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.
Time frame: postoperative 3 weeks
Population: Physical therapy adherence for patients not taking opioids and taking opioids at 3 week follow-up visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Knee Arthoplasty | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3 | PT Adherence | 290 Participants |
| Total Knee Arthoplasty | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3 | PT Non-adherence | 59 Participants |
| Opiates and Physical Therapy Adherence | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3 | PT Adherence | 28 Participants |
| Opiates and Physical Therapy Adherence | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3 | PT Non-adherence | 7 Participants |
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6
Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.
Time frame: Postoperative 6 weeks
Population: Physical therapy adherence for patients not taking opioids and taking opioids at 6 week follow-up visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Knee Arthoplasty | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6 | PT Adherence | 361 Participants |
| Total Knee Arthoplasty | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6 | PT Non-adherence | 12 Participants |
| Opiates and Physical Therapy Adherence | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6 | PT Non-adherence | 2 Participants |
| Opiates and Physical Therapy Adherence | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6 | PT Adherence | 10 Participants |
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12
Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.
Time frame: Postoperative 12 weeks
Population: Physical therapy adherence for patients not taking opioids and taking opioids at 12 week follow-up visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Knee Arthoplasty | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12 | PT Adherence | 297 Participants |
| Total Knee Arthoplasty | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12 | PT Non-adherence | 38 Participants |
| Opiates and Physical Therapy Adherence | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12 | PT Adherence | 2 Participants |
| Opiates and Physical Therapy Adherence | Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12 | PT Non-adherence | 0 Participants |