Use of Corticosteroid in Intraopertive Injections in Total Knee Replacement Surgery.
Summary
The goal of this clinical trial is to find out which type of steroid medicine, when added to a standard pain-control injection during total knee replacement surgery, works best at reducing pain, limiting opioid use, and improving recovery in adults undergoing surgery for severe knee arthritis or injury. The main questions it aims to answer are: Does adding a steroid to the injection improve pain control and reduce opioid use after surgery? Is the newer extended-release steroid (Zilretta) more effective and safer-especially for patients with diabetes-than the traditional steroid (methylprednisolone)? Researchers will compare: Standard pain-control injection alone Standard injection plus methylprednisolone Standard injection plus Zilretta to see which option provides better pain relief, less opioid use, and improved knee function. (Patients with diabetes or prediabetes will only be in the standard injection or Zilretta groups so researchers can study whether Zilretta is safer for blood sugar control.) Participants will: Be randomly assigned to one of the study groups during their total knee replacement surgery Receive the assigned pain-control injection around the knee joint Be followed after surgery to measure: Pain levels Opioid pain medication use Knee movement (range of motion) Whether another procedure (such as manipulation under anesthesia) is needed if the knee becomes too stiff Patient-reported outcome surveys about pain and function
Timeline
- Start
- 2025-09-01
- Primary completion
- 2026-08-31
- Completion
- 2026-08-31
Publications
- Background Su C, Liu Y, Wu P, Lang J, Chen L. Comparison Between Periarticular Analgesia Versus Intraarticular Injection for Effectiveness and Safety After Total Knee Arthroplasty. J Perianesth Nurs. 2022 Dec;37(6):952-955. doi: 10.1016/j.jopan.2022.04.010. Epub 2022 Sep 16.
- Background Hannon CP, Fillingham YA, Spangehl MJ, Karas V, Kamath AF, Casambre FD, Verity TJ, Nelson N, Hamilton WG, Della Valle CJ. The Efficacy and Safety of Periarticular Injection in Total Joint Arthroplasty: A Direct Meta-Analysis. J Arthroplasty. 2022 Oct;37(10):1928-1938.e9. doi: 10.1016/j.arth.2022.03.045.
- Results Wang Y, Li Z, Gao X, Lin J. The efficacy and safety of intra-articular injection of corticosteroids in multimodal analgesic cocktails in total knee arthroplasty-a historically controlled study. Front Surg. 2024 Jun 11;11:1279462. doi: 10.3389/fsurg.2024.1279462. eCollection 2024.
- Results Wainwright JD, Gugala Z, Krueger CA, Wenke JC. Adding corticosteroids to intra-operative periarticular injections in total knee arthroplasty: A systematic review. Knee. 2024 Aug;49:87-96. doi: 10.1016/j.knee.2024.05.009. Epub 2024 Jun 13.
- Results Wainwright JD, Alaraj S, Wenke JC. Systematic review of intraoperative corticosteroid injections and the risk of infection in arthroscopic surgery. J Clin Orthop Trauma. 2024 Jan 3;48:102332. doi: 10.1016/j.jcot.2024.102332. eCollection 2024 Jan.
- Results Sreedharan Nair V, Ganeshan Radhamony N, Rajendra R, Mishra R. Effectiveness of intraoperative periarticular cocktail injection for pain control and knee motion recovery after total knee replacement. Arthroplast Today. 2019 Jul 12;5(3):320-324. doi: 10.1016/j.artd.2019.05.004. eCollection 2019 Sep.
- Results Schwartz A, Cochrane NH, Jiranek WA, Ryan SP. Periarticular Injection in Total Knee Arthroplasty. J Am Acad Orthop Surg. 2023 Jun 15;31(12):614-619. doi: 10.5435/JAAOS-D-22-01179. Epub 2023 Apr 14.
- Results Russell SJ, Sala R, Conaghan PG, Habib G, Vo Q, Manning R, Kivitz A, Davis Y, Lufkin J, Johnson JR, Kelley S, Bodick N. Triamcinolone acetonide extended-release in patients with osteoarthritis and type 2 diabetes: a randomized, phase 2 study. Rheumatology (Oxford). 2018 Dec 1;57(12):2235-2241. doi: 10.1093/rheumatology/key265.
- Results Oshima A, Hatayama K, Terauchi M, Kakiage H, Hashimoto S, Chikuda H. The comparison of dexamethasone and triamcinolone periarticular administration in total knee arthroplasty: retrospective cohort study. BMC Musculoskelet Disord. 2022 Feb 5;23(1):120. doi: 10.1186/s12891-022-05048-8.
- Results Moon HK, Han CD, Yang IH, Cha BS. Factors affecting outcome after total knee arthroplasty in patients with diabetes mellitus. Yonsei Med J. 2008 Feb 29;49(1):129-37. doi: 10.3349/ymj.2008.49.1.129.
- Results Liu M, Zhang D, Shi B. Comparison of the Post-Total Knee Arthroplasty Analgesic Effect of Intraoperative Periarticular Injection of Different Analgesics. J Coll Physicians Surg Pak. 2019 Dec;29(12):1169-1172. doi: 10.29271/jcpsp.2019.12.1169.
- Results Li Q, Mu G, Liu X, Chen M. Efficacy of additional corticosteroids to multimodal cocktail periarticular injection in total knee arthroplasty: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2021 Jan 22;16(1):77. doi: 10.1186/s13018-020-02144-0.
- Results Kulkarni M, Mallesh M, Wakankar H, Prajapati R, Pandit H. Effect of Methylprednisolone in Periarticular Infiltration for Primary Total Knee Arthroplasty on Pain and Rehabilitation. J Arthroplasty. 2019 Aug;34(8):1646-1649. doi: 10.1016/j.arth.2019.04.060. Epub 2019 May 2.
- Results Kim JI, Kim YT, Jung HJ, Lee JK. Does adding corticosteroids to periarticular injection affect the postoperative acute phase response after total knee arthroplasty? Knee. 2020 Mar;27(2):493-499. doi: 10.1016/j.knee.2019.10.029. Epub 2019 Dec 2.
- Results Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794.
- Results Kg G, J R. Efficacy of Intraoperative Periarticular Local Infiltration for Pain Control and Ambulation in Total Knee Arthroplasty: A Randomized Case-Control Study. Cureus. 2024 Jan 20;16(1):e52639. doi: 10.7759/cureus.52639. eCollection 2024 Jan.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylprednisolone | Other / unclassified | 40 mg | Other |
| Comparator | Triamcinolone Acetonide | Other / unclassified | 32 mg | Other |
| Background | Clonidine | Other / unclassified | 0.8 ml | Other |
| Background | Epinephrine | Other / unclassified | 0.5 mg | Other |
| Background | Ketorolac | Other / unclassified | 30 mg | Other |
| Background | Ropivacaine | Other / unclassified | 49.25 ml | Other |