Efficacy of Modified Robert Jones Bandages on Reducing Invisible Blood Loss After Total Knee Arthroplasty

NCT02701946 | Completed

• 1 other identifier: 785/2558
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee arthroplasty (TKA) is one of the most successful procedures in orthopaedic surgery. Nevertheless, significant postoperative blood loss and requirement of blood transfusion are still problematic. Total blood loss in TKA can be divided into visible and invisible blood loss. Visible blood loss (VBL) means blood loss from the surgical field and wound drainage while invisible blood loss (IBL) means residual blood in the knee, extravasation into the tissues and loss due to haemolysis. In usual practice, TKA is performed with a bloodless field using a tourniquet. Thus intraoperative blood loss can be negligible and postoperative drainage is only considered as VBLvisible. In terms of IBL, Sehat et al. found that TKA carried a substantial IBL. Their results shown the mean IBL was 765 ml or 49% of the mean total blood loss after TKA. Therefore, the true total blood loss was underestimated if not takes IBL into account. Modified Robert Jones bandage (MRJB) is a bulky compressive dressing that often used in orthopaedic practice. Various techniques of application have been proposed. From the previous study, MRJB could make and maintain the anterolateral muscle compartment pressure for at least 24 hours after TKA. Therefore, theoretically, this bandage can cause the tamponade effect that helps to reduce tissue edema and postoperative bleeding especially IBL after TKA. However this potential benefit of MRJB is unclear and the use of this bandage after TKA is still controversy in clinical practice.

Conditions

Postoperative Blood Loss

Keywords

Blood loss; Total knee arthroplasty; Bandage; Dressing

Outcome Measures

Primary Outcomes (2)

• Invisible blood loss after surgery

  48 hours after surgery

• Time (seconds) taken to perform time up and go test

  meters, turn, walk back to the chair, then sit down.

  6 weeks after surgery

Secondary Outcomes (5)

• Postoperative visual analog pain score

  48 hours after surgery

• Circumferences of thigh

  48 hours after surgery

• Circumferences of knee

  48 hours after surgery

• Score from Oxford knee score questionnaire

  6 weeks after surgery

• Complication

  6 weeks after surgery

Study Arms (2)

Modified Robert Jones bandage

EXPERIMENTAL

Modified Robert Jones bandage is defined as a three-layers of thick cotton wool and two-layers of elastic bandages. The wool layers are put on firmly and overlapped the previous one by half at each turn. The elastic layers were pulled snugly with more tension distally than proximally. Before wrapping in each turn, the elastic bandage was stretched approximately 2 and 1.5 inches at below and above tibial tuberosity level, respectively. The whole bandage attains a thickness of about two inches and extends above the ankle joint to six inches above the knee joint. Before applying this bandage, the sterile gauze pads were placed over the wound and followed by WebrilTM padding (Covidien, Mansfield, MA, US).

Procedure: Modified Robert Jones bandage

Non compressive dressing

PLACEBO COMPARATOR

Non-compressive dressing is made by placing the sterile gauze pads over the wound and covering with the hypoallergenic self-adhesive, non-woven fabric tape.

Procedure: Non compressive dressing

Interventions

Modified Robert Jones bandage PROCEDURE

Modified Robert Jones bandage is defined as a three-layers of thick cotton wool and two-layers of elastic bandages. The wool layers are put on firmly and overlapped the previous one by half at each turn. The elastic layers were pulled snugly with more tension distally than proximally. Before wrapping in each turn, the elastic bandage was stretched approximately 2 and 1.5 inches at below and above tibial tuberosity level, respectively. The whole bandage attains a thickness of about two inches and extends above the ankle joint to six inches above the knee joint. Before applying this bandage, the sterile gauze pads were placed over the wound and followed by WebrilTM padding (Covidien, Mansfield, MA, US)

Modified Robert Jones bandage

Non compressive dressing PROCEDURE

Non-compressive dressing is made by placing the sterile gauze pads over the wound and covering with the hypoallergenic self-adhesive, non-woven fabric tape.

Non compressive dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who diagnosed primary osteoarthritis of knee and scheduled for primary unilateral total knee arthroplasty
• Patients aged more than 18 years

You may not qualify if:

• Patients who have a history of coagulopathy
• Patients who receive antiplatelet drug in the previous week
• Patients who treated other conditions with anticoagulant drug
• Patients who have previous history of thromboembolic event
• Patients who have vascular compromise of the operated limb
• Patients who have chronic kidney disease or liver cirrhosis
• Patients who refuse to participate the study
• Patients who have allergy to tranexamic acid, sulfa or morphine
• Patients who have blood loss per wound after surgery
• Patients who can not receive spinal anesthesia and peripheral nerve block

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Chaturong Pornrattanamaneewong

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Postoperative Hemorrhage; Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical instructor

Study Record Dates

• First Submitted: February 28, 2016
• First Posted: March 8, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)