Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy

Shandong University

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Drug: Sodium Chloride 0.9%; Other: Drainage Tube; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03954860

2019041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

No Drainage

Experimental group

Description:

The preoperative dose of tranexamic acid was calculated according to 20 mg / kg body weight, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 30 ml saline containing 2 g tranexamic acid was applied to the local area before loosening the tourniquet.Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. No drainage tube was placed after operation.

Treatment:

Drug: Tranexamic Acid

Drug: Sodium Chloride 0.9%

Drainage

Active Comparator group

Description:

The preoperative dose of tranexamic acid was calculated according to 20 mg / kg body weight, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 30 ml saline containing 2 g tranexamic acid was applied to the local area before loosening the tourniquet.Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. Drainage tube should be placed after operation.

Treatment:

Drug: Tranexamic Acid

Other: Drainage Tube

Drug: Sodium Chloride 0.9%