Status:
RECRUITING
Genicular Radiofrequency Ablation Following Total Knee Arthroplasty
Lead Sponsor:
University of Calgary
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Currently, nearly 1 million total knee arthroplasties (TKA) are performed yearly in the United States. Three million are projected to be performed in 2040. Between 15-30% of all patients who undergo T...
Detailed Description
The general objective of this study is to determine the safety and efficacy of GRFA in patients with failed TKA. The central hypothesis is that GRFA is safe and more efficacious in improving pain and ...
Eligibility Criteria
Inclusion
- \>1 year post TKA
- persistent knee pain \> 4/10 in intensity on average over the prior week of one of the post-TKA knees
- refractory to conventional treatment (i.e., physiotherapy, medication, etc.)
- ≥80% pain relief with a single fluoroscopically guided local anesthetic block using 0.5 mL of 2% lidocaine for the medial and lateral branches of the nerve to the vastus intermedialis, nerve to the vastus lateralis\*, inferior medial genicular nerve, infrapatellar branch of the saphenous nerve, and the recurrent fibular nerve. 0.5 mL will be injected over 2 spots (1.5 cm apart) for each of the superior medial and lateral genicular nerves corresponding to the sites of the RF cannulae for the bipolar strip lesions. \*Blocks will be combined fluoroscopy/ultrasound guided.
Exclusion
- Infection (peri-prosthetic, joint, systemic, skin/soft tissue overlying the knee to be treated)
- Prosthetic loosening or failure, periprosthetic fracture
- Severe psychiatric disorder
- Non-genicular lower extremity pain source from the spine (i.e., radiculopathy or neurogenic claudication) or peripheral joints (i.e., hip osteoarthritis)
- Peripheral vascular disease causing vascular claudication
- Connective tissue/inflammatory joint disease/widespread soft tissue pain disorder
- Poor tolerance of injection procedures (as observed from the prognostic local anesthetic blocks)
- Allergy to local anesthetic, synovial expansion into the anticipated path(s) of the local anesthetic needle/RF cannula as determined by ultrasound scanning
- Uncontrolled bleeding diathesis
- Pregnancy
- Pacemaker or neurostimulator
- Inability to complete Patient-Reported Outcome Measures due to cognitive or language limitations.
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05283889
Start Date
May 11 2022
End Date
December 1 2025
Last Update
December 5 2024
Active Locations (1)
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1
Vivo Cura Health
Calgary, Alberta, Canada, T2E2P5