Rotator Cuff Tears Clinical Trial
Official title:
Effects of the Application of a New Pharmacological Protocol for Shoulder Arthroscopy in Beach Chair Position
Verified date | July 2023 |
Source | Clinic for Orthopedics Lovran |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Shoulder arthroscopy provides many benefits with a permanent increase in the possibilities and complexity of the application. A condition to perform it is intraoperative visual clarity dependent on hemorrhage control. The aim of this prospective, double blind, randomized, and controlled study is to examine the effect of intravenously administered tranexamic acid (TXA) on the visual clarity, perioperative hemorrhage, duration and early postoperative course of shoulder arthroscopy in beach chair position, which is not yet available in the literature. In the tested and control group, the investigators measure hemoglobin (Hb) in the waste irrigation fluid and the patient's blood before and after the procedure, visual clarity, duration of the procedure, postoperative shoulder swelling, pain level and analgesic drug consumption. The research uses scientific methods to determine if there is a reasonable basis for introducing TXA into routine clinical use.
Status | Completed |
Enrollment | 104 |
Est. completion date | July 21, 2023 |
Est. primary completion date | July 21, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - rotator cuff tear - instability of the glenohumeral joint - instability of the acromioclavicular joint Exclusion Criteria: - allergy to tranexamic acid - deep vein thrombosis - congenital thrombophilia - coagulopathy - thromboembolic events last 12 months - stroke or acute coronary syndrome last 3 months - renal failure - cirrhosis of the liver - glaucoma or retinal vascular disorder - chronic treatment with anticoagulant therapy - uncontrolled hypertension |
Country | Name | City | State |
---|---|---|---|
Croatia | University orthopaedic and trauma hospital | Lovran | Primorsko Goranska |
Lead Sponsor | Collaborator |
---|---|
Nikola Matejcic | University of Rijeka, The Faculty of Medicine, University of Zagreb, The Faculty of Kinesiology, University orthopaedic and trauma hospital Lovran |
Croatia,
Ampat G, Bruguera J, Copeland SA. Aquaflo pump vs FMS 4 pump for shoulder arthroscopic surgery. Ann R Coll Surg Engl. 1997 Sep;79(5):341-4. — View Citation
Avery DM 3rd, Gibson BW, Carolan GF. Surgeon-rated visualization in shoulder arthroscopy: a randomized blinded controlled trial comparing irrigation fluid with and without epinephrine. Arthroscopy. 2015 Jan;31(1):12-8. doi: 10.1016/j.arthro.2014.08.010. Epub 2014 Nov 6. — View Citation
Bayram E, Yildirim C, Erturk AK, Yilmaz M, Atlihan D. Comparison of the efficacy of irrigation with epinephrine or tranexamic acid on visual clarity during arthroscopic rotator cuff repair: A double-blind, randomized-controlled study. Jt Dis Relat Surg. 2021;32(1):115-121. doi: 10.5606/ehc.2021.78393. Epub 2021 Jan 6. — View Citation
Belk JW, McCarty EC, Houck DA, Dragoo JL, Savoie FH, Thon SG. Tranexamic Acid Use in Knee and Shoulder Arthroscopy Leads to Improved Outcomes and Fewer Hemarthrosis-Related Complications: A Systematic Review of Level I and II Studies. Arthroscopy. 2021 Apr;37(4):1323-1333. doi: 10.1016/j.arthro.2020.11.051. Epub 2020 Dec 2. — View Citation
Burkhart SS, Danaceau SM, Athanasiou KA. Turbulence control as a factor in improving visualization during subacromial shoulder arthroscopy. Arthroscopy. 2001 Feb;17(2):209-12. doi: 10.1053/jars.2001.22298. — View Citation
Cripps CM. Rapid method for the estimation of plasma haemoglobin levels. J Clin Pathol. 1968 Jan;21(1):110-2. doi: 10.1136/jcp.21.1.110. No abstract available. — View Citation
Ersin M, Demirel M, Buget MI, Edipoglu IS, Atalar AC, Ersen A. The effect of intravenous tranexamic acid on visual clarity during arthroscopic rotator cuff repair: A randomized, double-blinded, placebo-controlled pilot study. Acta Orthop Traumatol Turc. 2020 Nov;54(6):572-576. doi: 10.5152/j.aott.2020.19164. — View Citation
Gao HL, Zhang JC, He Y, Zhai WT, Xiao LB, Shi Q. [Clinical study on the control of intra-articular hemorrhage by tranexamic acid after shoulder arthroscopy]. Zhongguo Gu Shang. 2020 Mar 25;33(3):238-41. doi: 10.12200/j.issn.1003-0034.2020.03.010. Chinese. — View Citation
Goldstein M, Feldmann C, Wulf H, Wiesmann T. Tranexamic Acid Prophylaxis in Hip and Knee Joint Replacement. Dtsch Arztebl Int. 2017 Dec 1;114(48):824-830. doi: 10.3238/arztebl.2017.0824. — View Citation
Hartland AW, Teoh KH, Rashid MS. Clinical Effectiveness of Intraoperative Tranexamic Acid Use in Shoulder Surgery: A Systematic Review and Meta-analysis. Am J Sports Med. 2021 Sep;49(11):3145-3154. doi: 10.1177/0363546520981679. Epub 2021 Jan 21. — View Citation
Jensen KH, Werther K, Stryger V, Schultz K, Falkenberg B. Arthroscopic shoulder surgery with epinephrine saline irrigation. Arthroscopy. 2001 Jul;17(6):578-81. doi: 10.1053/jars.2001.23590. — View Citation
Kirsch JM, Bedi A, Horner N, Wiater JM, Pauzenberger L, Koueiter DM, Miller BS, Bhandari M, Khan M. Tranexamic Acid in Shoulder Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2017 Sep;5(9):e3. doi: 10.2106/JBJS.RVW.17.00021. — View Citation
Li X, Eichinger JK, Hartshorn T, Zhou H, Matzkin EG, Warner JP. A comparison of the lateral decubitus and beach-chair positions for shoulder surgery: advantages and complications. J Am Acad Orthop Surg. 2015 Jan;23(1):18-28. doi: 10.5435/JAAOS-23-01-18. — View Citation
Liu YF, Hong CK, Hsu KL, Kuan FC, Chen Y, Yeh ML, Su WR. Intravenous Administration of Tranexamic Acid Significantly Improved Clarity of the Visual Field in Arthroscopic Shoulder Surgery. A Prospective, Double-Blind, and Randomized Controlled Trial. Arthroscopy. 2020 Mar;36(3):640-647. doi: 10.1016/j.arthro.2019.10.020. Epub 2019 Dec 20. — View Citation
Memon M, Kay J, Gholami A, Simunovic N, Ayeni OR. Fluid Extravasation in Shoulder Arthroscopic Surgery: A Systematic Review. Orthop J Sports Med. 2018 May 14;6(5):2325967118771616. doi: 10.1177/2325967118771616. eCollection 2018 May. — View Citation
Morrison DS, Schaefer RK, Friedman RL. The relationship between subacromial space pressure, blood pressure, and visual clarity during arthroscopic subacromial decompression. Arthroscopy. 1995 Oct;11(5):557-60. doi: 10.1016/0749-8063(95)90131-0. — View Citation
Ng W, Jerath A, Wasowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-50. doi: 10.5603/AIT.a2015.0011. Epub 2015 Mar 23. — View Citation
Nho SJ, Freedman KB, Bansal SL, Romeo AA, Bach BR Jr, Bush-Joseph CA, Turner DA, Cole BJ. The effect of radiofrequency energy on nonweight-bearing areas of bone following shoulder and knee arthroscopy. Orthopedics. 2005 Apr;28(4):392-9. doi: 10.3928/0147-7447-20050401-16. — View Citation
Parker JD, Lim KS, Kieser DC, Woodfield TBF, Hooper GJ. Is tranexamic acid toxic to articular cartilage when administered topically? What is the safe dose? Bone Joint J. 2018 Mar 1;100-B(3):404-412. doi: 10.1302/0301-620X.100B3.BJJ-2017-1135.R1. — View Citation
Rains DD, Rooke GA, Wahl CJ. Pathomechanisms and complications related to patient positioning and anesthesia during shoulder arthroscopy. Arthroscopy. 2011 Apr;27(4):532-41. doi: 10.1016/j.arthro.2010.09.008. Epub 2010 Dec 24. — View Citation
Rodriguez-Merchan EC. Tranexamic acid is effective in decreasing postoperative intraarticular bleeding in arthroscopic knee surgery. Blood Coagul Fibrinolysis. 2020 Apr;31(3):175-178. doi: 10.1097/MBC.0000000000000895. — View Citation
Smith JJ, Porth CM, Erickson M. Hemodynamic response to the upright posture. J Clin Pharmacol. 1994 May;34(5):375-86. doi: 10.1002/j.1552-4604.1994.tb04977.x. — View Citation
Tuijthof GJ, de Vaal MM, Sierevelt IN, Blankevoort L, van der List MP. Performance of arthroscopic irrigation systems assessed with automatic blood detection. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1948-54. doi: 10.1007/s00167-011-1495-z. Epub 2011 Apr 9. — View Citation
Tuijthof GJ, Dusee L, Herder JL, van Dijk CN, Pistecky PV. Behavior of arthroscopic irrigation systems. Knee Surg Sports Traumatol Arthrosc. 2005 Apr;13(3):238-46. doi: 10.1007/s00167-004-0573-x. Epub 2005 Jan 4. — View Citation
van Montfoort DO, van Kampen PM, Huijsmans PE. Epinephrine Diluted Saline-Irrigation Fluid in Arthroscopic Shoulder Surgery: A Significant Improvement of Clarity of Visual Field and Shortening of Total Operation Time. A Randomized Controlled Trial. Arthroscopy. 2016 Mar;32(3):436-44. doi: 10.1016/j.arthro.2015.08.027. — View Citation
Weber SC, Abrams JS, Nottage WM. Complications associated with arthroscopic shoulder surgery. Arthroscopy. 2002 Feb;18(2 Suppl 1):88-95. doi: 10.1053/jars.2002.31801. — View Citation
* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual clarity on endoscope screen during shoulder arthroscopy | The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time | At the very beginning of the shoulder arthroscopy | |
Primary | Visual clarity on endoscope screen during shoulder arthroscopy | The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time | After 15 minutes since the beginning of the surgery | |
Primary | Visual clarity on endoscope screen during shoulder arthroscopy | The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time | After 30 minutes since the beginning of the surgery | |
Primary | Visual clarity on endoscope screen during shoulder arthroscopy | The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time | After 45 minutes since the beginning of the surgery | |
Primary | Visual clarity on endoscope screen during shoulder arthroscopy | The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time | After 60 minutes since the beginning of the surgery | |
Primary | Visual clarity on endoscope screen during shoulder arthroscopy | The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time | After 75 minutes since the beginning of the surgery | |
Primary | Visual clarity on endoscope screen during shoulder arthroscopy | The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time | After 90 minutes since the beginning of the surgery | |
Primary | Visual clarity on endoscope screen during shoulder arthroscopy | The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time | After 105 minutes since the beginning of the surgery | |
Primary | Visual clarity on endoscope screen during shoulder arthroscopy | The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time | After 120 minutes since the beginning of the surgery | |
Primary | Visual clarity on endoscope screen during shoulder arthroscopy | The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time | After 135 minutes since the beginning of the surgery | |
Primary | Visual clarity on endoscope screen during shoulder arthroscopy | The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time | After 150 minutes since the beginning of the surgery | |
Primary | Visual clarity on endoscope screen during shoulder arthroscopy | Screen photos taken every 15 minutes during shoulder arthroscopy will be presented after surgery to three independent surgeons with experience in arthroscopy on visual clarity estimation using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) | Through study completion, an average of 1 year | |
Primary | Perioperative blood loss | The investigators will measure hemoglobin (Hb mg/100 mL) in the waste irrigation fluid collected during the surgery | Right after the surgery | |
Primary | Perioperative blood loss | The investigators will measure hemoglobin (Hb g/L) in the patient's blood before and after the procedure | 1 day before the surgery | |
Primary | Perioperative blood loss | The investigators will measure hemoglobin (Hb g/L) in the patient's blood before and after the procedure | 2nd day after the surgery | |
Primary | Early postoperative course of shoulder arthroscopy | The investigators will measure postoperative shoulder swelling. Shoulder circumference will be measured in centimeters (cm) at 3 typical sites one day before the surgery and 1st and 2nd day after the surgery | One day before the surgery | |
Primary | Early postoperative course of shoulder arthroscopy | The investigators will measure postoperative shoulder swelling. Shoulder circumference will be measured in centimeters (cm) at 3 typical sites one day before the surgery and 1st and 2nd day after the surgery | 1st day after the surgery | |
Primary | Early postoperative course of shoulder arthroscopy | The investigators will measure postoperative shoulder swelling. Shoulder circumference will be measured in centimeters (cm) at 3 typical sites one day before the surgery and 1st and 2nd day after the surgery | 2nd day after the surgery | |
Primary | Early postoperative course of shoulder arthroscopy | The investigators will measure postoperative pain level with Visual analog scale range from 0 (no pain) - 10 (the strongest pain) | 1st postoperative day | |
Primary | Early postoperative course of shoulder arthroscopy | The investigators will measure postoperative pain level with Visual analog scale range from 0 (no pain) - 10 (the strongest pain) | 2nd postoperative day | |
Primary | Early postoperative course of shoulder arthroscopy | The investigators will measure analgesic drug consumption (mg of peroral or injectable product of paracetamol) | During hospitalization (up to 7 days) | |
Primary | Early postoperative course of shoulder arthroscopy | The investigators will measure analgesic drug consumption (mg of peroral or injectable product of ketoprofen) | During hospitalization (up to 7 days) | |
Primary | Early postoperative course of shoulder arthroscopy | The investigators will measure analgesic drug consumption (mg of injectable product of metamizole) | During hospitalization (up to 7 days) | |
Primary | Early postoperative course of shoulder arthroscopy | The investigators will measure analgesic drug consumption (mg of injectable product of tramadol) | During hospitalization (up to 7 days) | |
Secondary | Difference in blood loss between different indications for performing shoulder arthroscopy | The investigators will measure hemoglobin (Hb mg/100 mL) in the waste irrigation fluid collected during the different types of shoulder arthroscopy | Right after the surgery | |
Secondary | Difference in blood loss between different indications for performing shoulder arthroscopy | The investigators will measure hemoglobin (Hb g/L) in the patient's blood before and after the different types of shoulder arthroscopy | 1 day before the surgery | |
Secondary | Difference in blood loss between different indications for performing shoulder arthroscopy | The investigators will measure hemoglobin (Hb g/L) in the patient's blood before and after the different types of shoulder arthroscopy | 2nd day after the surgery |
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