Skip to content

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06243575
Enrollment
20
Registered
2024-02-06
Start date
2024-02-01
Completion date
2024-12-31
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

total knee arthroplasty, intraosseous infiltration

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.

Interventions

DRUGMultimodal Intraosseous Femoral Injection

Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in femoral canal

DRUGMultimodal Intraosseous Tibial Injection

Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in tibial canal

Sponsors

Department of Medical Services Ministry of Public Health of Thailand
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain score (Visual analog scale)at 12 hours, 24 hours, 48 hours and 2 weeks after surgeryVisual 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

MeasureTime frameDescription
Post operative blood lossintraoperative and up to 48 hours postoperatively (include intraoperative and drain)
Knee and Osteoarthritis Outcome Score (KOOS)post operative 2 weeksminimum and maximum values(0-100), higher scores mean a better outcome.
Amount of painkillers usedup to 24 hours after surgery
Side effects and complicationsintraoperative to post operative 2weeks
Length of hospital stayAdmit to discharge date (up to 7 days)Length of hospital stay record in number of days
knee range of motionpost operative 2 weeks

Countries

Thailand

Contacts

Primary ContactThakrit Chompoosang, MD
tk_ortho@hotmail.com+66846461916
Backup ContactTanahem Wijit, MD
troy.erdos@gmail.com+66956855458

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026