Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:16 AM
Study NCT ID:
NCT07425457
Status:
RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryoneurolysis Prior to Total Knee Arthroplasty (CRYO-TKA Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-12-20', 'size': 57515, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-02-19T15:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain severity', 'timeFrame': '1 month postoperatively', 'description': 'Change in pain severity (Brief Pain Inventory-BPI) - Baseline to 1 month postoperatively.\n\nThe BPI typically assesses two primary domains using a 0 to 10 numerical rating scale:\n\nPain Intensity: Patients rate their pain at its "worst," "least," and "average" over the last 24 hours, as well as their pain "right now." 0 = No Pain 10 = Pain as bad as you can imagine\n\nPain Interference: Patients rate how much their pain interferes with seven daily activities (General Activity, Mood, Walking Ability, Normal Work, Relations with others, Sleep, and Enjoyment of Life).\n\n0 = Does not interfere 10 = Completely interferes\n\nBecause higher numbers represent more intense pain and more significant disruption to life, a reduction in score over time is the goal of most clinical treatments.'}], 'secondaryOutcomes': [{'measure': 'Knee Injury and Osteoarthritis Outcome Score', 'timeFrame': '3 and 6 months post-op', 'description': 'The Knee Injury and Osteoarthritis Outcome Score is a 42-item questionnaire designed to assess short-term and long-term consequences of knee injury. It covers five subscales: Pain, Symptoms, ADL, Sport/Rec, and QOL.\n\nEach subscale is transformed to a 0 to 100 scale. Unlike pain-only scales, higher scores mean a better outcome, with 100 representing a perfectly functional knee and 0 representing extreme knee problems.'}, {'measure': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': '3 and 6 months post-op', 'description': 'The Western Ontario and McMaster Universities Osteoarthritis Index is the "gold standard" for evaluating patients with hip and knee osteoarthritis.\n\nIt measures 24 items divided into pain, stiffness, and physical function. Using a Likert scale (0-4 per item), the total score ranges from 0 to 96. For the WOMAC, higher scores mean a worse outcome, reflecting increased pain and significant physical disability.'}, {'measure': 'The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Classification System', 'timeFrame': '6 months post-op', 'description': 'The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Classification System is a tool used by clinicians to standardize the reporting of complications in interventional radiology.\n\nIt ranks adverse events from Grade 1 to Grade 6. A Grade 1 signifies a minor issue with no therapy required, while a Grade 6 indicates patient death.\n\nTherefore, higher scores mean a worse outcome, representing a higher severity of medical complications.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cryoneurolysis', 'Interventional Radiology', 'Pain Management', 'Post-operative recovery'], 'conditions': ['Arthroplasty', 'Replacement Material', 'Knee Arthritis Osteoarthritis', 'Knee Arthroplasty, Total', 'Genicular Nerves', 'Chronic Pain']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Dasa V, Larijani GE, Kostajny B, et al. Percutaneous freezing of genicular nerves (cryoneurolysis) for pain management after total knee arthroplasty. Knee. 2016;23(3):523-528. doi:10.1016/j.knee.2016.01.015.'}, {'type': 'BACKGROUND', 'citation': 'Ashoorion V, et al. Predictors of persistent post-surgical pain following total knee arthroplasty: a systematic review and meta-analysis. Pain Med. 2023;24(4):369-381. doi:10.1093/pm/pnac144.'}, {'type': 'BACKGROUND', 'citation': 'Filippiadis D, Efthymiou E, Tsochatzis A, Kelekis A, Prologo JD. Percutaneous cryoanalgesia for pain palliation: current status and future trends. Diagn Interv Imaging. 2021;102(5):273-278. doi:10.1016/j.diii.2020.11.007.'}, {'type': 'BACKGROUND', 'citation': 'Mont MA, Mihalko WM, Chahal J, et al. Cryoneurolysis Associated With Improved Pain, Function, and Sleep in Patients Following Total Knee Arthroplasty. J Arthroplasty. 2025;40(1):92-101. doi:10.1016/j.arth.2024.05.035.'}]}, 'descriptionModule': {'briefSummary': 'Approximately 20-30% of patients experience persistent pain after a Total Knee Arthroplasty (TKA). This study investigates whether percutaneous cryoneurolysis of genicular nerves can reduce pain and improve physical function when performed at least 24 hours before surgery. Participants will be randomized to receive either the cryoneurolysis procedure + TKA or TKA only. Results will be tracked for 6 months to see if the intervention improves long-term recovery and quality of life.', 'detailedDescription': 'The current study is a prospective, single-center, randomized comparative trial (1:1 ratio). In the intervention group, cryoneurolysis is performed under imaging guidance targeting the upper lateral and medial and the lower medial genicular nerves. Under prophylactic antibiosis, and imaging guidance 17Gauge cryoprobes will be percutaneously placed at the level of the upper lateral and medial and the lower medial genicular nerves. The final position of each cryo probe will be verified with imaging guidance. Cryoneurolysis protocol will be 5min freezing-4min passive thawing-5min freezing. Post-interventional imaging will verify lack of potential immediate complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 years undergoing primary TKA for osteoarthritis.\n* Cognitively normal and able to self-assess pain and function.\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Cancer-related knee pain.\n* Neurological, psychiatric, or medical conditions interfering with assessment.\n* Chronic opioid users.'}, 'identificationModule': {'nctId': 'NCT07425457', 'acronym': 'CRYO-TKA', 'briefTitle': 'Cryoneurolysis Prior to Total Knee Arthroplasty (CRYO-TKA Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Attikon Hospital'}, 'officialTitle': 'Association of Pre-operative Genicular Nerves Cryoneurolysis With Improved Pain and Function in Patients Undergoing Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '499'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cryoneurolysis + TKA Arm', 'description': 'CT-guided cryoneurolysis of upper medial, upper lateral, and lower medial genicular nerves ≥24 hours before TKA.', 'interventionNames': ['Procedure: CT-guided Cryoneurolysis of the Genicular Nerves']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Standard total knee arthroplasty without preoperative cryoneurolysis.'}], 'interventions': [{'name': 'CT-guided Cryoneurolysis of the Genicular Nerves', 'type': 'PROCEDURE', 'description': 'Percutaneous CT-guided cryoneurolysis using up to three cryoprobes (-20°C to -100°C) for temporary sensory nerve interruption.', 'armGroupLabels': ['Cryoneurolysis + TKA Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12462', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Vasileios Balomenos, MD, MSc, PhD(c)', 'role': 'CONTACT', 'email': 'balomenosv@gmail.com', 'phone': '+306945297496'}], 'facility': 'Attikon University General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Dimitrios Filippiadis, MD, PhD, EBIR, MSc', 'role': 'CONTACT', 'email': 'dfillipiadis@yahoo.gr', 'phone': '+306948513104'}, {'name': 'Vasileios Balomenos, MD, MSc, PhD(c)', 'role': 'CONTACT', 'email': 'balomenosv@gmail.com', 'phone': '+30645297496'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'IPD and supporting information will be available from June 1st, 2026. End date has not beed decided yet.', 'ipdSharing': 'YES', 'description': 'De-identified data will be available upon reasonable request following publication of primary results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Attikon Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Vasileios Balomenos', 'investigatorAffiliation': 'Attikon Hospital'}}}}