Comparison of Outcomes Between Intraosseous Femoral and Tibial Injection in Simultaneous Bilateral Total Knee Arthroplasty Patients

Comparison of Outcomes Between Multimodal Intraosseous Femoral Injection and Multimodal Intraosseous Tibial Injection, a Randomized Controlled Trial in Simultaneous Bilateral Total Knee Arthroplasty Patients

In patients with osteoarthritis of the knee whose pain cannot be relieved by conservative treatment, total knee arthroplasty (TKA) is the operation that increases the quality of life for the patient. Pain management after total knee arthroplasty TKA is an important consideration to improve patient outcomes and reduce length of stay. Periarticular injections of the knee are one of the techniques used to reduce pain after surgery. Studies have shown that compared to other methods of pain relief, they are effective and safe. At present, no studies to compare between multimodal intraosseous femoral injection & multimodal intraosseous tibial injection in Simultaneous Bilateral TKA patients.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Multimodal Intraosseous Femoral Injection; Drug: Multimodal Intraosseous Tibial Injection

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thakrit Chompoosang, MD; Phone Number: +66846461916; Email: tk_ortho@hotmail.com
• Study Contact Backup: Name: Tanahem Wijit, MD; Phone Number: +66956855458; Email: troy.erdos@gmail.com

Study Locations

• Thailand
  • Bangkok
    • Phaya Thai, Bangkok, Thailand, 10400
      • Recruiting
      • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who will undergo bilateral Total knee Replacement due to osteoarthritis of both knees
• Used of a cemented, PS design TKA surgery.
• Able to give informed consent

Exclusion Criteria:

• Revision TKA
• History of previous knee or hip surgery
• History of allergic reaction or side effects to the drug that will be used in the experiment
• Underlying diseases of chronic kidney disease or chronic liver disease (Child Pugh B or C)
• Pregnancy
• History of coagulopathy or abnormal blood coagulation profile(INR >1.4 or aPTT ratio > 1.4)
• History of platelet dysfunction or platelet count < 140,0000/mm3
• History of Thromboembolism
• Use of Anticoagulants.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal Intraosseous Femoral Injection; Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in femoral canal	Drug: Multimodal Intraosseous Femoral Injection; Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in femoral canal
Experimental: Multimodal Intraosseous Tibial Injection; Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in tibial canal	Drug: Multimodal Intraosseous Tibial Injection; Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in tibial canal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score (Visual analog scale)	Visual analog scale (VAS) score from 0-10(0 was no pain, 10 was worst pain ) between multimodal intraosseous femoral injection & multimodal intraosseous tibial injection	at 12 hours, 24 hours, 48 hours and 2 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of painkillers used		up to 24 hours after surgery
Post operative blood loss		intraoperative and up to 48 hours postoperatively (include intraoperative and drain)
Knee and Osteoarthritis Outcome Score (KOOS)	minimum and maximum values(0-100), higher scores mean a better outcome.	post operative 2 weeks
knee range of motion		post operative 2 weeks
Side effects and complications		intraoperative to post operative 2weeks
Length of hospital stay	Length of hospital stay record in number of days	Admit to discharge date (up to 7 days)

Collaborators and Investigators

• Sponsor: Rajavithi Hospital
• Investigators: Study Director: Thakrit Chompoosang, MD, Rajavithi Hospital

Publications and helpful links

General Publications

• Brozovich AA, Incavo SJ, Lambert BS, Sullivan TC, Wininger AE, Clyburn TA, Taraballi F, Park KJ. Intraosseous Morphine Decreases Postoperative Pain and Pain Medication Use in Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2022 Jun;37(6S):S139-S146. doi: 10.1016/j.arth.2021.10.009. Epub 2022 Mar 7.
• Fan L, Zhu C, Zan P, Yu X, Liu J, Sun Q, Li G. The Comparison of Local Infiltration Analgesia with Peripheral Nerve Block following Total Knee Arthroplasty (TKA): A Systematic Review with Meta-Analysis. J Arthroplasty. 2015 Sep;30(9):1664-71. doi: 10.1016/j.arth.2015.04.006. Epub 2015 Apr 8.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): March 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: total knee arthroplasty; intraosseous infiltration
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: 149/66

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No