Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-04 @ 3:09 AM
Study NCT ID:
NCT06594003
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Sparing Techniques, Genicular Nerve Radiofrequency Ablation Has Emerged As a Viable Alternative to Conservative Therapy and Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vas score', 'timeFrame': '4 weeks', 'description': 'will be assessed at 0, 1, and 4 weeks. on the Visual Analogue Scale (VAS) (0 = no pain, 10 = unbearable pain).'}], 'secondaryOutcomes': [{'measure': 'Total WOMAC score.', 'timeFrame': '4 weeks', 'description': 'will be assessed at 0, 1, and 4 weeks'}, {'measure': 'seven-point Likert scale', 'timeFrame': '4 weeks', 'description': 'seven-point Likert scale (one = worst ever, two = much worse, three = worse, four = not improved but not worse, five = improved, six = much improved, and seven = best ever).'}, {'measure': 'analgesic request', 'timeFrame': '4 weeks'}, {'measure': 'adverse effects', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee', 'osteoarthritis', 'radiofrequency', 'genicular nerves'], 'conditions': ['Knee Osteoarthritis \\(OA\\)']}, 'referencesModule': {'references': [{'pmid': '38929474', 'type': 'BACKGROUND', 'citation': 'Kwon HJ, Kim CS, Kim DH, Shin JW, Choi D, Choi SS. Effectiveness of the Cooled Radiofrequency Ablation of Genicular Nerves in Patients with Chronic Knee Pain Due to Osteoarthritis: A Double-Blind, Randomized, Controlled Study. Medicina (Kaunas). 2024 May 24;60(6):857. doi: 10.3390/medicina60060857.'}, {'pmid': '31257831', 'type': 'BACKGROUND', 'citation': 'Dass RM, Kim E, Kim HK, Lee JY, Lee HJ, Rhee SJ. Alcohol neurolysis of genicular nerve for chronic knee pain. Korean J Pain. 2019 Jul 1;32(3):223-227. doi: 10.3344/kjp.2019.32.3.223.'}, {'pmid': '28835778', 'type': 'BACKGROUND', 'citation': 'Wehling P, Evans C, Wehling J, Maixner W. Effectiveness of intra-articular therapies in osteoarthritis: a literature review. Ther Adv Musculoskelet Dis. 2017 Aug;9(8):183-196. doi: 10.1177/1759720X17712695. Epub 2017 Jun 20.'}, {'pmid': '31333900', 'type': 'BACKGROUND', 'citation': 'Kidd VD, Strum SR, Strum DS, Shah J. Genicular Nerve Radiofrequency Ablation for Painful Knee Arthritis: The Why and the How. JBJS Essent Surg Tech. 2019 Mar 13;9(1):e10. doi: 10.2106/JBJS.ST.18.00016. eCollection 2019 Mar 26.'}, {'pmid': '38155108', 'type': 'BACKGROUND', 'citation': 'Karm MH, Kwon HJ, Kim CS, Kim DH, Shin JW, Choi SS. Cooled radiofrequency ablation of genicular nerves for knee osteoarthritis. Korean J Pain. 2024 Jan 1;37(1):13-25. doi: 10.3344/kjp.23344.'}, {'pmid': '37745043', 'type': 'BACKGROUND', 'citation': 'Geng R, Li J, Yu C, Zhang C, Chen F, Chen J, Ni H, Wang J, Kang K, Wei Z, Xu Y, Jin T. Knee osteoarthritis: Current status and research progress in treatment (Review). Exp Ther Med. 2023 Aug 25;26(4):481. doi: 10.3892/etm.2023.12180. eCollection 2023 Oct.'}, {'pmid': '33801304', 'type': 'BACKGROUND', 'citation': "Primorac D, Molnar V, Matisic V, Hudetz D, Jelec Z, Rod E, Cukelj F, Vidovic D, Vrdoljak T, Dobricic B, Anticevic D, Smolic M, Miskulin M, Cacic D, Boric I. Comprehensive Review of Knee Osteoarthritis Pharmacological Treatment and the Latest Professional Societies' Guidelines. Pharmaceuticals (Basel). 2021 Mar 2;14(3):205. doi: 10.3390/ph14030205."}, {'pmid': '32722615', 'type': 'BACKGROUND', 'citation': 'Primorac D, Molnar V, Rod E, Jelec Z, Cukelj F, Matisic V, Vrdoljak T, Hudetz D, Hajsok H, Boric I. Knee Osteoarthritis: A Review of Pathogenesis and State-Of-The-Art Non-Operative Therapeutic Considerations. Genes (Basel). 2020 Jul 26;11(8):854. doi: 10.3390/genes11080854.'}, {'pmid': '35686229', 'type': 'BACKGROUND', 'citation': 'Ng TK, Lam KHS, Allam AE. Motor-Sparing Neural Ablation with Modified Techniques for Knee Pain: Case Series on Knee Osteoarthritis and Updated Review of the Underlying Anatomy and Available Techniques. Biomed Res Int. 2022 May 31;2022:2685898. doi: 10.1155/2022/2685898. eCollection 2022.'}, {'pmid': '37615856', 'type': 'BACKGROUND', 'citation': 'Leite CBG, Merkely G, Charles JF, Lattermann C. From Inflammation to Resolution: Specialized Pro-resolving Mediators in Posttraumatic Osteoarthritis. Curr Osteoporos Rep. 2023 Dec;21(6):758-770. doi: 10.1007/s11914-023-00817-3. Epub 2023 Aug 24.'}, {'type': 'BACKGROUND', 'citation': '1. Байбусунова А, Нысанбай Г, Шварц Д, Жакеева М. Diagnosis and treatment of knee osteoarthritis: Modern aspects. J Orthop Trauma. 2024;48(12):21-9.'}]}, 'descriptionModule': {'briefSummary': 'There has recently been considerable interest in the role of radiofrequency ablation (RFA) of the genicular nerves for KOA. In the majority of previous studies, ablation was done via a radiofrequency technique using either fluoroscopy or ultrasound for only three genicular nerves, whereas the knee joint is also supplied by a few other nerves (11, 12). Interestingly, neurolytic agents can also be used to ablate the nerves, and are readily available, less costly, and need less logistic support', 'detailedDescription': 'Knee pain is a common issue in adults, with a steadily increasing prevalence (1). There are many causes of knee pain, such as meniscal and tendon injuries, posttraumatic syndrome, and postsurgical pain; osteoarthritis is the leading cause (2).\n\nKnee osteoarthrosis (KOA) is a very common joint disease, with a prevalence ranging from 4.2% to 15.5% and gradually increasing with age (3). It is associated with diverse causes including age, obesity, metabolic bone diseases, and acute or chronic joint injuries. Pain and disabilities are the major consequences of KOA, with 25% of patients suffering from severe arthralgia. KOA is believed to be a result of the failure of chondrocytes to maintain homeostasis between the synthesis and degradation of the extracellular matrix and from subchondral bone developing osteoarthrosis (4, 5).\n\nAlthough traditional treatment modalities, including analgesics, physical therapy, and intra-articular steroid (IAS) injections, have long been employed to manage symptoms, the growing need for more effective and minimally invasive interventions has prompted the exploration of novel approaches (6).\n\nAmong these newer treatments, motor sparing techniques, genicular nerve radiofrequency ablation has emerged as a viable alternative to conservative therapy and total knee arthroplasty (7).\n\nGenicular nerve ablation is a known procedure to help these cases as they transfer the pain signal of the knee. It is usually reserved for patients with symptomatic knee osteoarthritis who have had failure of conservative treatment and have had failure of or are poor candidates for surgery (8).\n\nHowever, there is a high failure rate among the patients undergoing the procedure as regarding the efficacy or the duration of pain relief and various methods have been used to increase the rate of success and the duration of the pain relief such as using alcohol in the ablation, cooled radiofrequency or increase the lesions on the nerves (9, 10).\n\nThere has recently been considerable interest in the role of radiofrequency ablation (RFA) of the genicular nerves for KOA. In the majority of previous studies, ablation was done via a radiofrequency technique using either fluoroscopy or ultrasound for only three genicular nerves, whereas the knee joint is also supplied by a few other nerves (11, 12). Interestingly, neurolytic agents can also be used to ablate the nerves, and are readily available, less costly, and need less logistic support (13).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age from 50-70 years.\n* Both sexes.\n* American Society of Anesthesiology (ASA) physical status I-III.\n* Patients with 3rd and 4th degree of KOA pain who undergo knee articular branch denervation via RF ablation.\n\nExclusion Criteria:\n\n* Deformities in knee.\n* Charcot joint (stiff Joint)\n* Acute knee injury\n* Previous ipsilateral total knee arthroplasty or radiofrequency denervation.\n* Instability of knee Joint.\n* Knee effusion \\& Baker's cyst . . Inability to assume a recumbent or semirecumbent position."}, 'identificationModule': {'nctId': 'NCT06594003', 'briefTitle': 'Motor Sparing Techniques, Genicular Nerve Radiofrequency Ablation Has Emerged As a Viable Alternative to Conservative Therapy and Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparative Study Between Eight Versus Three Genicular Nerves Radiofrequency Ablation for Knee Denervation in Advanced Knee Osteoarthritis Using Ultrasound', 'orgStudyIdInfo': {'id': 'genicular nerves ablation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'three genicular nerves raiofrequency ablation', 'interventionNames': ['Procedure: Radiofrequency']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'eight genicular nerves radiofrequency ablation', 'interventionNames': ['Procedure: Radiofrequency']}], 'interventions': [{'name': 'Radiofrequency', 'type': 'PROCEDURE', 'description': 'There has recently been considerable interest in the role of radiofrequency ablation (RFA) of the genicular nerves for KOA. In the majority of previous studies, ablation was done via a radiofrequency technique using either fluoroscopy or ultrasound for only three genicular nerves, whereas the knee joint is also supplied by a few other nerves . Interestingly, neurolytic agents can also be used to ablate the nerves, and are readily available, less costly, and need less logistic support', 'armGroupLabels': ['eight genicular nerves radiofrequency ablation', 'three genicular nerves raiofrequency ablation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Amal Ibrahim Amal Ibrahim Mubarak, assistant lecturer', 'role': 'CONTACT', 'email': 'amalibrahim210@gmail.com', 'phone': '01067820046', 'phoneExt': '+2'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'teaching assistant', 'investigatorFullName': 'Amal Ibrahim Mubarak', 'investigatorAffiliation': 'Assiut University'}}}}