| Primary | Maximum Pain Post-Operative Day (POD) 1 (Morning) | Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable. | | Posted | | Median | Inter-Quartile Range | units on a scale | | Post-Operative Day 1, approximately 6 am to 12:00 pm | | | | ID | Title | Description |
|---|
| OG000 | Peripheral Nerve Block (PNB) | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. | | OG001 | Ropivacaine (PAI-R) | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. | | OG002 | Liposomal Bupivacaine (PAI-L) | This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0003(1 to 6)
- OG0014(2 to 6)
- OG0024.5(3 to 6)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Wilcoxon (Mann-Whitney) | | 0.144 | | | | | | | | | | | | | | Superiority | | | | | Wilcoxon (Mann-Whitney) | | 0.016 | |
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| Secondary | Average Pain Post-Postanesthesia Care Unit (PACU) | Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable. | | Posted | | Median | Inter-Quartile Range | units on a scale | | Post-operative Day 0, approximately 12 pm to 12 am | | | | ID | Title | Description |
|---|
| OG000 | Peripheral Nerve Block (PNB) | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. | | OG001 | Ropivacaine (PAI-R) | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. | | OG002 | Liposomal Bupivacaine (PAI-L) | |
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| Secondary | Maximum Pain Post-PACU | Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable. | | Posted | | Median | Inter-Quartile Range | units on a scale | | Post-operative Day 0, approximately 12 pm to 12 am | | | | ID | Title | Description |
|---|
| OG000 | Peripheral Nerve Block (PNB) | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. | | OG001 | Ropivacaine (PAI-R) | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. | | OG002 | Liposomal Bupivacaine (PAI-L) | This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. |
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| Secondary | Average Pain POD 1 (24 Hours) | Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable. | | Posted | | Median | Inter-Quartile Range | units on a scale | | POD 1, approximately 12 am to 12 am next day | | | | ID | Title | Description |
|---|
| OG000 | Peripheral Nerve Block (PNB) | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. | | OG001 | Ropivacaine (PAI-R) | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. | | OG002 | Liposomal Bupivacaine (PAI-L) | This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. |
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| Secondary | Maximum Pain POD 1 (24 Hours) | Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable. | | Posted | | Median | Inter-Quartile Range | units on a scale | | POD 1, approximately 12 am to 12 am next day | | | | ID | Title | Description |
|---|
| OG000 | Peripheral Nerve Block (PNB) | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. | | OG001 | Ropivacaine (PAI-R) | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. | | OG002 | Liposomal Bupivacaine (PAI-L) | This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. |
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| Secondary | Average Pain POD 2 (24 Hours) | Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable. | Intent-to-Treat Analysis. For POD 2, data are missing for 5 subjects (1 on Peripheral Nerve Block (PNB) arm, 1 on Ropivacaine (PAI-R) arm, and 3 on Liposomal Bupivacaine (PAI-L) arm). | Posted | | Median | Inter-Quartile Range | units on a scale | | POD 2, approximately 12 am to 12 am next day | | | | ID | Title | Description |
|---|
| OG000 | Peripheral Nerve Block (PNB) | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. | | OG001 | Ropivacaine (PAI-R) | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. | | OG002 |
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| Secondary | Maximum Pain POD 2 (24 Hours) | Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable. | Intent-to-Treat Analysis. For POD 2, data are missing for 5 subjects (1 on PNB arm, 1 on PAI-R arm, and 3 on PAI-L arm). | Posted | | Median | Inter-Quartile Range | units on a scale | | POD 2, approximately 12 am to 12 am next day | | | | ID | Title | Description |
|---|
| OG000 | Peripheral Nerve Block (PNB) | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. | | OG001 | Ropivacaine (PAI-R) | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. | | OG002 | Liposomal Bupivacaine (PAI-L) |
|
| Secondary | Preoperative Daily Opioid Use | Opioid consumption will be documented in the patient electronic medical record by the nursing staff caring for the patient. | | Posted | | Median | Inter-Quartile Range | mg oral morphine equivalents (OME) | | baseline | | | | ID | Title | Description |
|---|
| OG000 | Peripheral Nerve Block (PNB) | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. | | OG001 | Ropivacaine (PAI-R) | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. | | OG002 | Liposomal Bupivacaine (PAI-L) | This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. |
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| Secondary | Intraoperative Opioid Use | Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient. | | Posted | | Median | Inter-Quartile Range | mg OME | | During the procedure, approximately 2 hours after start of the procedure | | | | ID | Title | Description |
|---|
| OG000 | Peripheral Nerve Block (PNB) | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. | | OG001 | Ropivacaine (PAI-R) | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. | | OG002 | Liposomal Bupivacaine (PAI-L) | |
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| Secondary | PACU Opioid Use | Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient. | | Posted | | Median | Inter-Quartile Range | mg OME | | Approximately 2 hours after entry in PACU | | | | ID | Title | Description |
|---|
| OG000 | Peripheral Nerve Block (PNB) | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. | | OG001 | Ropivacaine (PAI-R) | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. | | OG002 | Liposomal Bupivacaine (PAI-L) | This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. |
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| Secondary | POD 0 Post-PACU Opioid Use | Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient. | | Posted | | Median | Inter-Quartile Range | mg OME | | POD 0, approximately 12 pm to 12 am | | | | ID | Title | Description |
|---|
| OG000 | Peripheral Nerve Block (PNB) | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. | | OG001 | Ropivacaine (PAI-R) | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. | | OG002 | Liposomal Bupivacaine (PAI-L) |
|
| Secondary | POD 1 Opioid Use | Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient. | | Posted | | Median | Inter-Quartile Range | mg OME | | POD 1, approximately 12 am to 12 am next day | | | | ID | Title | Description |
|---|
| OG000 | Peripheral Nerve Block (PNB) | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. | | OG001 | Ropivacaine (PAI-R) | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. | | OG002 | Liposomal Bupivacaine (PAI-L) |
|
| Secondary | POD 2 Opioid Use | Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient. | Intent-to-treat analysis. For POD 2, data are missing for 5 subjects (1 on PNB arm, 1 on PAI-R arm, and 3 on PAI-L arm). | Posted | | Median | Inter-Quartile Range | mg OME | | POD 2, approximately 12 am to 12 am next day | | | | ID | Title | Description |
|---|
| OG000 | Peripheral Nerve Block (PNB) | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. | | OG001 | Ropivacaine (PAI-R) | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. | |
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| Secondary | Hospital Length of Stay | The hospital length of stay was measured from the date of admittance until the date of discharge. | | Posted | | Median | Inter-Quartile Range | days | | Approximately 3 days | | | | ID | Title | Description |
|---|
| OG000 | Peripheral Nerve Block (PNB) | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. | | OG001 | Ropivacaine (PAI-R) | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. | | OG002 | Liposomal Bupivacaine (PAI-L) | This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. |
|
| Secondary | Balance Testing on Operative Leg Using Unipedal Stance Time | In order to measure clinical balance, unipedal stance time (UST) was collected as an indicator of balance and fall risk. Timing (in seconds) began upon withdrawal of support and continued until the uplifted foot returned to the floor, the subject required support, or if the subject reached a time limit of 30 seconds. The best performance of three repetitions was recorded for analysis. Normative values for the UST are available. A UST threshold of 30 seconds yields a sensitivity of 95% and a specificity of 58% in identifying those with a history of falls. The first five seconds of unipedal stance is indicative of dynamic balance; inability to maintain unipedal stance for five seconds is a significant predictor of injurious falls. | | Posted | | Median | Inter-Quartile Range | seconds | | baseline, approximately 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Peripheral Nerve Block (PNB) | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. | | OG001 | Ropivacaine (PAI-R) | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. |
|