Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
9 participants
INTERVENTIONAL
2016-12-31
2018-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to evaluate whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
As the prevalence of knee arthroplasty increases, so does the frequency of revisions. It has been found that 20% of patients reporting painful knee arthroplasties were not able to be diagnosed with a specific cause and were therefore referred to a pain specialist. Pharmacologic therapy and non-surgical interventions are often employed with minimal benefit to the patient's level of disability as indicated by clinical evidence.
Genicular radiofrequency ablation seems to be a safe, effective and minimally invasive therapy for chronic knee OA patients who have had a positive diagnostic block. No study has determined whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain. The investigators propose to examine the effect of genicular radiofrequency ablation in chronic post-arthroplasty knee pain in patients who respond positively to diagnostic nerve blocks.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nerve Block with Radiofrequency Ablation
A 10 cm 18-gauge RF cannula with a 10 mm active tip will be placed at the superior lateral, superior medial, and inferior medial nerve positions under fluoroscopic guidance. Sensory stimulation at 50 Hz will be performed to identify nerve position and to assure no motor nerves will be ablated. Lidocaine (2 ml of 2%) will be administered in each location prior to RF generator activation.
Nerve Block with Radiofrequency Ablation
Ablation of the genicular nerves of the knee by radiofrequency
Nerve Block with Sham Radiofrequency Ablation
A 10 cm 18-gauge RF cannula with a 10 mm active tip will be placed at the superior lateral, superior medial, and inferior medial nerve positions under fluoroscopic guidance.Control patients will undergo the same procedure without RF generator activation. Sensory stimulation at 50 Hz will be performed to identify nerve position and to assure no motor nerves will be ablated. Lidocaine (2 ml of 2%) will be administered in each location prior to RF generator sham activation.
Nerve Block with Sham Radiofrequency Ablation
Genicular radiofrequency of the knee without neurotomy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nerve Block with Radiofrequency Ablation
Ablation of the genicular nerves of the knee by radiofrequency
Nerve Block with Sham Radiofrequency Ablation
Genicular radiofrequency of the knee without neurotomy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must be ≥ 50 years of age at the time of consent
* Chronic knee pain despite total knee arthroplasty at least 6 months prior to consent
* Orthopedic evaluation indicating no further surgery is warranted
* Stable pain medication regimen for 30 days prior to baseline visit
* Knee pain is primary pain complaint
Exclusion Criteria
* Connective tissue disorders affecting the knee
* Serious neurologic or psychiatric disorders that would affect the outcome of the study as determined by the Principal Investigator
* Steroid or hyaluronic acid injections into the affected knee in the past 3 months
* Confounding pain conditions of the index leg that may affect medication requirements or study outcomes
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott Medical Devices
INDUSTRY
Abbott
INDUSTRY
Randall Brewer, MD, CPI
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Randall Brewer, MD, CPI
Medical Director, Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Randall Brewer, MD
Role: PRINCIPAL_INVESTIGATOR
WK River Cities Clinical Research Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
WK River Cities Clinical Research Center
Shreveport, Louisiana, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
Nikolaou VS, Chytas D, Babis GC. Common controversies in total knee replacement surgery: Current evidence. World J Orthop. 2014 Sep 18;5(4):460-8. doi: 10.5312/wjo.v5.i4.460. eCollection 2014 Sep 18.
Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
Al-Hadithy N, Rozati H, Sewell MD, Dodds AL, Brooks P, Chatoo M. Causes of a painful total knee arthroplasty. Are patients still receiving total knee arthroplasty for extrinsic pathologies? Int Orthop. 2012 Jun;36(6):1185-9. doi: 10.1007/s00264-011-1473-6. Epub 2012 Jan 11.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GENRF
Identifier Type: -
Identifier Source: org_study_id