Clinical trial NCT03954860: Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy
Official title: Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to evaluate the safety and efficacy of topical combined with intravenous tranexamic acid for high tibial osteotomy without placement of a drainage tube The clinical scores of patients and their possible risks were tracked. The investigators hypothesized that a combination of tranexamic acid and no drainage tube could reduce blood loss and facilitate early recovery. The implementation of the study will provide a new perioperative blood loss control program for High Tibial Osteotomy, reduce the cost of hospitalization, promote patients to get out of bed early, reduce the number of days in hospital.

Detailed description: The condition of the patients was evaluated, and the total length of both lower limbs, anteroposterior position of knee and Mri of knee were included. The preoperative dose of tranexamic acid was calculated according to body weight of 20 mg / kg, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and after incision closure, 30 ml of normal saline solution containing 2 g of tranexamic acid was injected through drainage tube or subcutaneously. Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. Arthroscopy was first used to further confirm the cartilage defect, and a new type of lower limb alignment meter and a customized precise osteotomy template were used to perform the osteotomy according to the preoperative plan. One group was not placed drainage tube, the other group was placed drainage tube. Visual analogue pain score (Vas) and American Special Surgical Hospital (HSS) knee function score were recorded 3 month after surgery. Throughout the trial, the investigators will carefully observe and manage your complications and the outcome of your surgery.

Eligibility criteria: Inclusion Criteria:

1. Simple knee medial compartment osteoarthritis High tibial osteotomy.
2. With varus deformity, medial proximal tibia angle \<85°
3. Unilateral High tibial osteotomy
4. informed consent: Participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process

Exclusion Criteria:

1. patients who underwent other knee surgery within 6 months
2. Preoperative combined anemia (Hb\<100g/l)
3. Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases
4. Patient with preoperative coagulation abnormalities 5. Patients with allergies and patients allergic to TXA.

Primary outcomes:
measure: Postoperative blood loss
timeFrame: The third day after operation
measure: Haemoglobin
timeFrame: The third day after operation
measure: Hematocrit
timeFrame: The third day after operation
measure: Hospital for special surgery knee score
timeFrame: postoperative 3 month
measure: Visual Analogue Scale Postoperative Day One
timeFrame: Postoperative Day One
measure: Visual Analogue Scale Postoperative Day Three
timeFrame: Postoperative Day Three
measure: Visual Analogue Scale Postoperative Day Five
timeFrame: Postoperative Day Five
measure: Circumference of shank Postoperative Day One
timeFrame: Postoperative Day One
measure: Circumference of shank Postoperative Day Three
timeFrame: Postoperative Day Three
measure: Circumference of shank Postoperative Day Five
timeFrame: Postoperative Day Five
measure: Number of blood transfusions
timeFrame: Postoperative Day Three
measure: Number of Incision infection
timeFrame: postoperative 3 month
measure: Number of hematoma formation
timeFrame: postoperative 3 month
measure: Number of delayed healing of the incision.
timeFrame: On the 14th day after operation
measure: Volume of drainage
timeFrame: Postoperative Day One
Secondary outcomes:
measure: Activated partial thromboplastin time
timeFrame: The third day after operation
measure: Prothrombin time
timeFrame: The third day after operation
measure: Concentration of D-dimer
timeFrame: The third day after operation
measure: Concentration of Fibrinogen
timeFrame: The third day after operation
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Peilai Liu, Ph.D
role: STUDY_CHAIR
References:
citation: Kim KI, Kim HJ, Kim GB, Bae SH. Tranexamic acid is effective for blood management in open-wedge high tibial osteotomy. Orthop Traumatol Surg Res. 2018 Nov;104(7):1003-1007. doi: 10.1016/j.otsr.2018.07.019. Epub 2018 Sep 20.
citation: Palanisamy JV, Das S, Moon KH, Kim DH, Kim TK. Intravenous Tranexamic Acid Reduces Postoperative Blood Loss After High Tibial Osteotomy. Clin Orthop Relat Res. 2018 Nov;476(11):2148-2154. doi: 10.1097/CORR.0000000000000378.
citation: Suh DW, Kyung BS, Han SB, Cheong K, Lee WH. Efficacy of Tranexamic Acid for Hemostasis in Patients Undergoing High Tibial Osteotomy. J Knee Surg. 2018 Jan;31(1):50-55. doi: 10.1055/s-0037-1600091. Epub 2017 Mar 29.
citation: Zhang Q, Zhang Q, Guo W, Liu Z, Cheng L, Zhu G. No need for use of drainage after minimally invasive unicompartmental knee arthroplasty: a prospective randomized, controlled trial. Arch Orthop Trauma Surg. 2015 May;135(5):709-13. doi: 10.1007/s00402-015-2192-z. Epub 2015 Mar 8.
citation: Huang Z, Xie X, Li L, Huang Q, Ma J, Shen B, Kraus VB, Pei F. Intravenous and Topical Tranexamic Acid Alone Are Superior to Tourniquet Use for Primary Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Dec 20;99(24):2053-2061. doi: 10.2106/JBJS.16.01525.
citation: Chan JJ, Cirino CM, Huang HH, Poeran J, Mazumdar M, Parsons BO, Anthony SG, Galatz LM, Cagle PJ Jr. Drain Use is Associated with Increased Odds of Blood Transfusion in Total Shoulder Arthroplasty: A Population-Based Study. Clin Orthop Relat Res. 2019 Jul;477(7):1700-1711. doi: 10.1097/CORR.0000000000000728.
citation: Legnani C, Oriani G, Parente F, Ventura A. Reducing transfusion requirements following total knee arthroplasty: effectiveness of a double infusion of tranexamic acid. Eur Rev Med Pharmacol Sci. 2019 Mar;23(5):2253-2256. doi: 10.26355/eurrev_201903_17273.
citation: Nishitani K, Kuriyama S, Nakamura S, Ito H, Matsuda S. A Multivariate Analysis on the Effect of No Closed Suction Drain on the Length of Hospital Stay in Total Knee Arthroplasty. Knee Surg Relat Res. 2019 Mar 1;31(1):25-30. doi: 10.5792/ksrr.18.013.
citation: Li S, Yang J, Watson C, Lu Q, Zhang M, Miao Z, Luo D, Liu P. Drainage relieves pain without increasing post-operative blood loss in high tibial osteotomy: a prospective randomized controlled study. Int Orthop. 2020 Jun;44(6):1037-1043. doi: 10.1007/s00264-020-04530-z. Epub 2020 Mar 14.