Genicular radiofrequency ablation for knee osteoarthritis following failed total knee replacement
Summary
The general objective of this application is to determine if a minimally invasive pain modulation procedure involving the sensory nerves in the knee can reduce pain following a failed (i.e. ongoing pain) total knee replacement.
Unfortunately,15-30% of TKA recipients continue to experience knee pain, reduced quality of life and functional impairment (failed TKA) and have few unexplored treatment options. 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 treat refractory knee osteoarthritis (OA). Although sometimes used clinically, there is only sparse low quality research evaluating GRFA for patients with failed TKA. The general objective of this application 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 function than sham GRFA.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 50 to 100
Inclusion criteria:
1. >50 years old
2. >1 year post total knee replacement
3. Persistent knee pain ≥ 4/10 in intensity on average over the prior week in one of the post-TKA knees
4. Has not responded to conventional treatment (i.e. physiotherapy, medication, etc.)
5. ≥80% pain relief with X-ray guided blocks of the sensory nerves of the knee joint
Exclusion criteria:
1. Infection presence
2. Loosening of the internal knee joint replacement
3. Severe psychiatric disorder,
4. Pain not arising from the knee (e.g. from hip or spine)
5. Peripheral vascular disease
6. Connective tissue/inflammatory joint disease/widespread soft tissue pain disorder,
7. Poor tolerance of injection procedures (as observed from the nerve blocks to the knee)
8. Allergy to local anesthetic,
9. Uncontrolled bleeding,
10. Pregnancy, pacemaker or neurostimulator,
11. Inability to complete PROMs due to cognitive or language limitations.
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Additional information
Contact information
Jennifer Laxshimalla: jennifer.laxshimalla@vivocura.ca
Principal investigator:
Ashley Smith
Clinical trial:
Yes
REB-ID:
REB21-2105