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Prospective Cohort of patients who are scheduled for a Robot Assisted Total Knee Arthroplasty (RATKA). A prospective survey of patient reported outcome measures (Numeric Rating Scale) will be obtained postoperatively of 72 hours, as well as at the postoperative opioid consumption after 72 hours.
Opioid use is a well-discussed issue in the United States among orthopedic surgeons, as while these drugs are helpful and necessary, they pose the risk of addiction and ultimately should be used as sparingly as possible. By taking a multimodal approach to pain management, this can be successfully achieved. Periarticular injections are currently used to achieve this goal, and 2021 a bupivacaine-meloxicam extended-release periarticular injection (Zynrelef) was introduced and is regularly implemented into RATKAs. Randomized clinical trials found that Zynrelef's use in traditional total knee arthroplasties (TKA) was just as effective as standard periarticular injections in reducing opioid use and pain, but whether Zynrelef works just as well if not better in RATKA is not yet established.
Objectives: (primary and important secondary objectives)
To evaluate the improvement in pain and use of opioids of a patient who received Zynrelef after undergoing RATKA compared to the traditional periarticular injections commonly used. The secondary objective will be documentation of the patient's use of other oral (over-the-counter) OTC pain relievers, such as acetaminophen or NSAIDs (non-steroidal anti inflammatory drugs).
Study Design:
Prospective Cohort Study (double arm)
Setting/Participants:
Patients who have undergone a standard of care RATKA at any Allegheny Health Network facility who consent to filling out a survey addressing their reported outcomes.
Study Interventions and Measures:
Patients will be evaluated with the Numeric Rating Scale (NRS) on postoperative days 1-3. Patients will be given paper forms which will be collected by the physicians at their next postoperative visit. A retrospective review of Epic Electronic Medical Records (EMR) will also be conducted to describe basic demographic characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zynrelef | Experimental | Periarticular injection of bupivacaine-meloxicam extended release |
|
| Control | Active Comparator | Periarticular injection of bupivacaine, ketorolac, and lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupivacaine-meloxicam (extended release) | Combination Product | These surgeons will be using Zynrelef (bupivacaine-meloxicam extended release) as a form of periarticular analgesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of opioid medications used (measured in morphine milligrams equivalents) | Self-report of opioid medications | From completion of surgery to 3 days post-op |
| Patient reported outcome measure (Numeric Rating Scale) | Self-report of pain using numeric scale. Title: Numeric Rating Scale; Ranges from 0 to 10, where 10 is maximal pain and 0 is no pain at all. | From completion of surgery to 3 days post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of oral Over-the-counter (OTC) pain reliever medications used | Self-report of Over-the-counter (OTC) pain relievers | From completion of surgery to 3 days post-operation |
| Complications and Adverse Events |
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Inclusion Criteria:
Males or females aged 18-89 years
Diagnosed with knee osteoarthritis requiring surgical intervention
Indicated for unilateral RATKA
Exclusion Criteria:
Pediatric, pregnant, or incarcerated patients
BMI of more than 45 kg/m2
Prolonged opioid use history of >5 mg/day for >1 month
History of contralateral TKA <2 years prior to the index TKA
Type 1 Hypersensitivity to NSAIDs or local anesthetics
Diagnosis of severe renal disease
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Obinna Ajah, MD | Contact | 877-660-6777 | obinna.ajah@ahn.org |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Waligora, MD | Allegheny Health Network | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35848995 | Background | Joo PY, Chen AF, Richards J, Law TY, Taylor K, Marchand K, Clark G, Collopy D, Marchand RC, Roche M, Mont MA, Malkani AL. Clinical results and patient-reported outcomes following robotic-assisted primary total knee arthroplasty : a multicentre study. Bone Jt Open. 2022 Aug;3(8):589-595. doi: 10.1302/2633-1462.37.BJO-2022-0076.R1. | |
| 40711999 |
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| Bupivacaine | Drug | These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia. |
|
| Ketorolac | Drug | These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia. |
|
| Lidocaine (drug) | Drug | These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia. |
|
Report of adverse events
| From completion of surgery to 3 days post-op |
| Salmons HI, Amundson AW, Duncan CM, Larson DR, Mallinger BD, Couch CG, Pagnano MW, Trousdale RT, Abdel MP. Bupivacaine-Meloxicam Extended-Release Solution Compared with a Standard Periarticular Injection in Primary Total Knee Arthroplasty: A Randomized Clinical Trial Showing Similar Efficacy in Postoperative Analgesia. J Bone Joint Surg Am. 2025 Jul 25;107(17):1918-1925. doi: 10.2106/JBJS.25.00086. |
| 34228280 | Background | Blair HA. Bupivacaine/Meloxicam Prolonged Release: A Review in Postoperative Pain. Drugs. 2021 Jul;81(10):1203-1211. doi: 10.1007/s40265-021-01551-9. Epub 2021 Jul 6. |
| 31985959 | Background | Dydyk AM, Jain NK, Gupta M. Opioid Use Disorder: Evaluation and Management. 2024 Jan 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK553166/ |
| 34505846 | Background | Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020 Nov 26;29-30:100587. doi: 10.1016/j.eclinm.2020.100587. eCollection 2020 Dec. |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D020910 | Ketorolac |
| D008012 | Lidocaine |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
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