Osteoarthritis, Knee Clinical Trial
— GRATKAOfficial title:
The Safety and Efficacy of Genicular Radiofrequency Ablation for Patients With Persistent Knee Pain Following Total Knee Arthroplasty - A Triple Blinded Randomized Sham-Controlled Trial
NCT number | NCT05283889 |
Other study ID # | REB21-2105 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 11, 2022 |
Est. completion date | December 2024 |
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 TKA have continued pain, reduced quality of life and functional impairments that cannot be attributed to hardware failure/loosening or infection. Treatment options for persistent post TKA pain (failed TKA) are limited. There is a need for minimally invasive, and effective pain and disability modulating interventions for patients with failed TKA. Genicular radiofrequency ablation (GRFA) has been described, refined, and validated as an effective minimally invasive intervention to control refractory knee pain secondary to knee osteoarthritis (OA) as evidenced by three favorable meta-analyses published in 2021 alone.3-5 GRFA is a minimally invasive percutaneous procedure that utilizes thermal energy to coagulate nerves from the knee. Though sometimes used in practice, there is limited research describing and evaluating GRFA for patients with failed TKA. This will be the first trial to evaluate the safety and efficacy of GRFA in patients with failed TKA using a robust study design and up-to-date, evidence-based selection criteria and technique.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - >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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Vivo Cura Health | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average Pain Intensity Over the Prior week (0 - 10) | Numerical pain rating scale (0 - 10) with higher scores indicating a worse outcome | 6 months | |
Primary | Change in pain intensity between pre- and 6-months post-intervention | Numerical Pain rating scale (NPRS) 6 month minus NPRS pre-intervention, with increased negative scores indicating a better outcome | 6 months | |
Primary | Proportion of participants exceeding 50% pain relief | Proportion of participants that experience = 50% pain relief | 6 months | |
Primary | Proportion of participants exceeding Minimal Clinically Important Difference (MCID) pain relief | Proportion of participants that experience MCID knee pain relief | 6 months | |
Primary | Safety - Adverse Events | Presence of self-reported complications | 1-week, 3, 6 and 12-months post-intervention | |
Secondary | Average Pain Intensity Over the Prior Week (0 - 10) | Numerical pain rating scale (0 - 10) with higher scores indicating worse outcomes | 3 and 12-months post-intervention | |
Secondary | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Measure of pain (0 - 20), stiffness (0 - 8) and physical function (0 - 68) with higher scores indicating wore pain, stiffness and functional limitations | 3, 6 and 12-months post-intervention | |
Secondary | The Clinical Global Impressions Scale (CGI) | Patient reported global impression of change (1 = Very Much Improved to 7 = Very Much Worse) | 3, 6 and 12-months post-intervention | |
Secondary | Perceived Need for Revision Arthroplasty | "If revision surgery of your knee replacement was available to you, how interested would you be in having it at this time?" Y or N | Baseline (Prior to), 3, 6 and 12-months post-intervention | |
Secondary | Analgesic Use | Quantitative Analgesic Questionnaire | Baseline (Prior to), 3, 6 and 12-months post-intervention | |
Secondary | Health-related Quality of Life | EQ-5D-5L | Baseline (Prior to), 3, 6 and 12-months post-intervention |
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