drugset / Trial / NCT05465382
Effect of Early Saline Lavage on Synovial Fluid Composition Following Intra Articular Ankle Fractures
RandomizedParallel-groupSingle-blindPrevention
Summary
The purpose of this study is to examine the effect of early, percutaneous, intra-articular saline lavage on the undiluted synovial fluid microenvironment during the acute phase following intra-articular fracture of the human ankle. We hypothesize that early intervention with percutaneous joint lavage in the first 0-48 hours after injury will attenuate the production of pro-inflammatory cytokines, MMP's and cartilage breakdown products compared to non-lavaged control subjects at the time of surgical fixation.
Timeline
- Start
- 2022-07-22
- Primary completion
- 2024-05-07
- Completion
- 2024-05-07
Outcome
Outcome not reported
Stopped (Enrollment): “Low accrual”
Publications
- Background Huch K, Kuettner KE, Dieppe P. Osteoarthritis in ankle and knee joints. Semin Arthritis Rheum. 1997 Feb;26(4):667-74. doi: 10.1016/s0049-0172(97)80002-9.
- Background Brown TD, Johnston RC, Saltzman CL, Marsh JL, Buckwalter JA. Posttraumatic osteoarthritis: a first estimate of incidence, prevalence, and burden of disease. J Orthop Trauma. 2006 Nov-Dec;20(10):739-44. doi: 10.1097/01.bot.0000246468.80635.ef.
- Background Delco ML, Kennedy JG, Bonassar LJ, Fortier LA. Post-traumatic osteoarthritis of the ankle: A distinct clinical entity requiring new research approaches. J Orthop Res. 2017 Mar;35(3):440-453. doi: 10.1002/jor.23462. Epub 2016 Nov 8.
- Background Buckwalter JA, Brown TD. Joint injury, repair, and remodeling: roles in post-traumatic osteoarthritis. Clin Orthop Relat Res. 2004 Jun;(423):7-16.
- Background McKinley TO, Tochigi Y, Rudert MJ, Brown TD. The effect of incongruity and instability on contact stress directional gradients in human cadaveric ankles. Osteoarthritis Cartilage. 2008 Nov;16(11):1363-9. doi: 10.1016/j.joca.2008.04.005. Epub 2008 Jun 3.
- Background Dirschl DR, Marsh JL, Buckwalter JA, Gelberman R, Olson SA, Brown TD, Llinias A. Articular fractures. J Am Acad Orthop Surg. 2004 Nov-Dec;12(6):416-23. doi: 10.5435/00124635-200411000-00006.
- Background Giannoudis PV, Tzioupis C, Papathanassopoulos A, Obakponovwe O, Roberts C. Articular step-off and risk of post-traumatic osteoarthritis. Evidence today. Injury. 2010 Oct;41(10):986-95. doi: 10.1016/j.injury.2010.08.003.
- Background Allen NB, Abar B, Danilkowicz RM, Kraus VB, Olson SA, Adams SB. Intra-Articular Synovial Fluid With Hematoma After Ankle Fracture Promotes Cartilage Damage In Vitro Partially Attenuated by Anti-Inflammatory Agents. Foot Ankle Int. 2022 Mar;43(3):426-438. doi: 10.1177/10711007211046952. Epub 2021 Oct 7.
- Background Hembree WC, Ward BD, Furman BD, Zura RD, Nichols LA, Guilak F, Olson SA. Viability and apoptosis of human chondrocytes in osteochondral fragments following joint trauma. J Bone Joint Surg Br. 2007 Oct;89(10):1388-95. doi: 10.1302/0301-620X.89B10.18907.
- Background Adams SB, Setton LA, Bell RD, Easley ME, Huebner JL, Stabler T, Kraus VB, Leimer EM, Olson SA, Nettles DL. Inflammatory Cytokines and Matrix Metalloproteinases in the Synovial Fluid After Intra-articular Ankle Fracture. Foot Ankle Int. 2015 Nov;36(11):1264-71. doi: 10.1177/1071100715611176. Epub 2015 Oct 8.
- Background Adams SB, Reilly RM, Huebner JL, Kraus VB, Nettles DL. Time-Dependent Effects on Synovial Fluid Composition During the Acute Phase of Human Intra-articular Ankle Fracture. Foot Ankle Int. 2017 Oct;38(10):1055-1063. doi: 10.1177/1071100717728234. Epub 2017 Sep 11.
- Background Kimmerling KA, Furman BD, Mangiapani DS, Moverman MA, Sinclair SM, Huebner JL, Chilkoti A, Kraus VB, Setton LA, Guilak F, Olson SA. Sustained intra-articular delivery of IL-1RA from a thermally-responsive elastin-like polypeptide as a therapy for post-traumatic arthritis. Eur Cell Mater. 2015 Jan 31;29:124-39; discussion 139-40. doi: 10.22203/ecm.v029a10.
- Background Furman BD, Mangiapani DS, Zeitler E, Bailey KN, Horne PH, Huebner JL, Kraus VB, Guilak F, Olson SA. Targeting pro-inflammatory cytokines following joint injury: acute intra-articular inhibition of interleukin-1 following knee injury prevents post-traumatic arthritis. Arthritis Res Ther. 2014 Jun 25;16(3):R134. doi: 10.1186/ar4591.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Lidocaine | Other / unclassified | 1 % | Other |
| Background | Lidocaine | Other / unclassified | 10 ml | Other |
Indications
No indication recorded.