Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-01-03 @ 1:16 AM
Study NCT ID:
NCT02931435
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2016-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrequency For Chronic Knee Pain Post-Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009407', 'term': 'Nerve Block'}, {'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-11', 'studyFirstSubmitDate': '2016-10-05', 'studyFirstSubmitQcDate': '2016-10-10', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean difference in knee pain intensities as indicated on the Visual Analog Scale', 'timeFrame': 'Baseline and 6 weeks post-radiofrequency ablation'}], 'secondaryOutcomes': [{'measure': 'Change in Visual Analog Score of average knee pain', 'timeFrame': 'Baseline to 1 week, 6 weeks, and 12 weeks'}, {'measure': 'Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': 'Baseline to 1 week, 6 weeks, and 12 weeks'}, {'measure': 'Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'Baseline to 1 week, 6 weeks, and 12 weeks'}, {'measure': 'Change of Patient Global Assessment', 'timeFrame': 'Baseline to 1 week, 6 weeks, and 12 weeks'}, {'measure': 'Satisfaction with Radiofrequency Procedure', 'timeFrame': 'Baseline to 1 week, 6 weeks, and 12 weeks'}, {'measure': 'Rate of procedure-related Adverse Events', 'timeFrame': 'From informed consent through study completion, up to 20 weeks'}, {'measure': 'Rate of Serious Adverse Events', 'timeFrame': 'From informed consent through study completion, up to 20 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Genicular Radiofrequency Ablation', 'Knee Arthroplasty, Total'], 'conditions': ['Chronic Knee Pain', 'Osteoarthritis, Knee']}, 'referencesModule': {'references': [{'pmid': '17403800', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25232522', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21055873', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22234706', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.\n\nThe purpose of this study is to evaluate whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain.', 'detailedDescription': "Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.\n\nAs 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.\n\nGenicular 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Study candidate must provide written informed consent.\n* Must be ≥ 50 years of age at the time of consent\n* Chronic knee pain despite total knee arthroplasty at least 6 months prior to consent\n* Orthopedic evaluation indicating no further surgery is warranted\n* Stable pain medication regimen for 30 days prior to baseline visit\n* Knee pain is primary pain complaint\n\nExclusion Criteria:\n\n* Acute knee pain\n* Connective tissue disorders affecting the knee\n* Serious neurologic or psychiatric disorders that would affect the outcome of the study as determined by the Principal Investigator\n* Steroid or hyaluronic acid injections into the affected knee in the past 3 months\n* Confounding pain conditions of the index leg that may affect medication requirements or study outcomes'}, 'identificationModule': {'nctId': 'NCT02931435', 'acronym': 'DEFIANT', 'briefTitle': 'Radiofrequency For Chronic Knee Pain Post-Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Willis-Knighton River Cities Clinical Research Center'}, 'officialTitle': 'Radiofrequency For The Treatment Of Chronic Knee Pain Following Total Knee Arthroplasty: A Double-Blind Randomized Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'GENRF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nerve Block with Radiofrequency Ablation', 'description': '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.', 'interventionNames': ['Procedure: Nerve Block with Radiofrequency Ablation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Nerve Block with Sham Radiofrequency Ablation', 'description': '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.', 'interventionNames': ['Procedure: Nerve Block with Sham Radiofrequency Ablation']}], 'interventions': [{'name': 'Nerve Block with Radiofrequency Ablation', 'type': 'PROCEDURE', 'description': 'Ablation of the genicular nerves of the knee by radiofrequency', 'armGroupLabels': ['Nerve Block with Radiofrequency Ablation']}, {'name': 'Nerve Block with Sham Radiofrequency Ablation', 'type': 'PROCEDURE', 'description': 'Genicular radiofrequency of the knee without neurotomy', 'armGroupLabels': ['Nerve Block with Sham Radiofrequency Ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71105', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'WK River Cities Clinical Research Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}], 'overallOfficials': [{'name': 'Randall Brewer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'WK River Cities Clinical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Randall Brewer, MD, CPI', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, {'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Director, Principal Investigator', 'investigatorFullName': 'Randall Brewer, MD, CPI', 'investigatorAffiliation': 'Willis-Knighton River Cities Clinical Research Center'}}}}