NCT02841644|CompletedResults
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Sponsor study identifier
observational
180
1 country
4
Study Start
April 2015
Actual (reported)Primary Completion
April 2019
Actual (reported)Study Completion
April 2020
Actual (reported)For the last 70 years, orthopaedic dogma has dictated that all injuries that penetrate the joint capsule require formal irrigation and debridement in the operating room to minimize the risk of developing septic complications. The literature supporting this practice is sparse and stems primarily from wartime injuries that may not be generalizable to the smaller, less contaminated arthrotomies seen in the civilian population. Despite the classical teaching of all traumatic arthrotomies requiring irrigation, debridement, and closure in the operating room, numerous surgeons around the country are beginning to treat small traumatic arthrotomies without surgery. The purpose of this study is to evaluate the cost of treatment as well as incidence of adverse events, such as the development of septic arthritis, in patients undergoing operative and non-operative treatment of traumatic arthrotomies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2015
Actual (reported)June 27, 2016
Actual (reported)July 22, 2016
Actual (reported)April 2019
Actual (reported)April 2020
Actual (reported)August 3, 2021
Actual (reported)Cost of Treatments
To compare the cost of medical care in patients with traumatic arthrotomies treated with surgical irrigation and debridement versus non-operative treatment with local wound care. To estimate cost associated with TAs, total charge data was acquired for all patients treated at the lead site.
12 months
Complications
Complications were defined as septic arthritis, return to the OR, rehospitalization, and osteomyelitis of the injured joint.
12 months
Comparing 3-Month Change in Veterans RAND 12-Item Health Survey (VR-12) by Treatment Method
baseline, 3 months
Patient diagnosed with traumatic arthrotomy treated nonoperatively.
Patient diagnosed with traumatic arthrotomy treated operatively.
operatively treated traumatic arthrotomy.
non-operatively treated traumatic arthrotomy.
Any patient 18 years and older with a traumatic arthrotomy
University of Kentucky
Lexington, Kentucky, 40506, United States
Carolinas Medical Center- Main
Charlotte, North Carolina, 28204, United States
Greenville Health System
Greenville, South Carolina, 29605, United States
The University of Tennessee Health Science Center
Memphis, Texas, 38163, United States
HAMPTON OP Jr. The management of penetrating wounds and suppurative arthritis of the knee joint in the Mediterranean Theater of Operations. J Bone Joint Surg Am. 1946 Oct;28(4):659-80. No abstract available.
Levy AS, Lefkoe TP, Whitelaw GP, Kohler S. Management of penetrating pneumatic nailgun injuries of the knee. J Orthop Trauma. 1991;5(1):66-70. doi: 10.1097/00005131-199103000-00012.
Patzakis MJ, Dorr LD, Ivler D, Moore TM, Harvey JP Jr. The early management of open joint injuries. A prospective study of one hundred and forty patients. J Bone Joint Surg Am. 1975 Dec;57(8):1065-70.
Joseph Hsu, MD
Wake Forest University Health Sciences
180 participants (actual enrollment reported by the registry).
First Submitted
June 27, 2016
First Posted
July 22, 2016
Study Start
April 2015
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Marvel JE, Marsh HO. Management of penetrating injuries of the knee. Clin Orthop Relat Res. 1977 Jan-Feb;(122):268-72.
Lanier WL. A three-decade perspective on anesthesia safety. Am Surg. 2006 Nov;72(11):985-9; discussion 1021-30, 1133-48. doi: 10.1177/000313480607201101.
Botney R. Improving patient safety in anesthesia: a success story? Int J Radiat Oncol Biol Phys. 2008;71(1 Suppl):S182-6. doi: 10.1016/j.ijrobp.2007.05.095.
Wolters U, Wolf T, Stutzer H, Schroder T. ASA classification and perioperative variables as predictors of postoperative outcome. Br J Anaesth. 1996 Aug;77(2):217-22. doi: 10.1093/bja/77.2.217.
Chander S, Coakley G. What's New in the Management of Bacterial Septic Arthritis? Curr Infect Dis Rep. 2011 Oct;13(5):478-84. doi: 10.1007/s11908-011-0201-0.
Tornetta P 3rd, Boes MT, Schepsis AA, Foster TE, Bhandari M, Garcia E. How effective is a saline arthrogram for wounds around the knee? Clin Orthop Relat Res. 2008 Feb;466(2):432-5. doi: 10.1007/s11999-007-0006-5. Epub 2008 Jan 10.
Nord RM, Quach T, Walsh M, Pereira D, Tejwani NC. Detection of traumatic arthrotomy of the knee using the saline solution load test. J Bone Joint Surg Am. 2009 Jan;91(1):66-70. doi: 10.2106/JBJS.G.01682.
Metzger P, Carney J, Kuhn K, Booher K, Mazurek M. Sensitivity of the saline load test with and without methylene blue dye in the diagnosis of artificial traumatic knee arthrotomies. J Orthop Trauma. 2012 Jun;26(6):347-9. doi: 10.1097/BOT.0b013e3182255167.
McKnight RR, Ruffolo M, Wally MK, Seymour RB, Jeray K, E Matuszewski P, Weinlein J, Hsu JR; Southeast Fracture Consortium. Traumatic Arthrotomies: Do They All Need the Operating Room? J Orthop Trauma. 2021 Nov 1;35(11):612-618. doi: 10.1097/BOT.0000000000002093.
Primary Completion
April 2019
Actual (reported)Study Completion
April 2020
Actual (reported)Last Updated
July 14, 2022
Results First Posted
August 3, 2021
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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