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

Not Applicable

Recruiting

• Conditions: Pain, Postoperative
• Interventions: Drug: Multimodal Intraosseous Femoral Injection; Drug: Multimodal Intraosseous Tibial Injection

• Registration Number: NCT06243575
• Lead Sponsor: Rajavithi Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-28
• Study Start: 2024-02-01
• Study First Posted: 2024-02-06
• Primary Completion: 2024-03-30
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal Intraosseous Femoral Injection	Multimodal Intraosseous Femoral Injection	Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in femoral canal
Multimodal Intraosseous Tibial Injection	Multimodal Intraosseous Tibial Injection	Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in tibial canal

Primary Outcome Measures

Name	Time	Method
Pain score (Visual analog scale)	at 12 hours, 24 hours, 48 hours and 2 weeks after surgery	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

Secondary Outcome Measures

Name	Time	Method
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)	post operative 2 weeks	minimum and maximum values(0-100), higher scores mean a better outcome.
Length of hospital stay	Admit to discharge date (up to 7 days)	Length of hospital stay record in number of days
knee range of motion	post operative 2 weeks
Side effects and complications	intraoperative to post operative 2weeks

Trial Locations

Locations (1)

Rajavithi hospital; 🇹🇭 Phaya Thai, Bangkok, Thailand