Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-02 @ 1:48 AM
Study NCT ID:
NCT05059535
Status:
TERMINATED
Last Update Posted:
2025-05-16
First Post:
2021-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007718', 'term': 'Knee Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'whyStopped': 'the recruitment rate is far too low despite an 18-month extension of the inclusion period', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2021-09-17', 'studyFirstSubmitQcDate': '2021-09-17', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '90 ° flexion pain 2 days after the arthroscopy', 'timeFrame': '2 days', 'description': 'Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm'}], 'secondaryOutcomes': [{'measure': '90 ° flexion pain 1 day after the arthroscopy', 'timeFrame': '1 day', 'description': 'Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm'}, {'measure': '90 ° flexion pain 7 days after the arthroscopy', 'timeFrame': '7 days', 'description': 'Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm'}, {'measure': '90 ° flexion pain 30 days after the arthroscopy', 'timeFrame': '30 days', 'description': 'Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm'}, {'measure': '90 ° flexion pain 90 days after the arthroscopy', 'timeFrame': '90 days', 'description': 'Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm'}, {'measure': 'pain at rest at Day 1', 'timeFrame': '1 day', 'description': 'Knee pain after intervention with a visual analogic scale of 100 mm'}, {'measure': 'pain at rest at Day 2', 'timeFrame': '2 days', 'description': 'Knee pain after intervention with a visual analogic scale of 100 mm'}, {'measure': 'pain at rest at Day 7', 'timeFrame': '7 days', 'description': 'Knee pain after intervention with a visual analogic scale of 100 mm'}, {'measure': 'pain at rest at Day 30', 'timeFrame': '30 days', 'description': 'Knee pain after intervention with a visual analogic scale of 100 mm'}, {'measure': 'pain at rest at Day 90', 'timeFrame': '90 days', 'description': 'Knee pain after intervention with a visual analogic scale of 100 mm'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Injuries']}, 'descriptionModule': {'briefSummary': 'Interventional, comparative, randomized, controlled study versus standard treatment, in 3 parallel groups, monocentric, aiming to demonstrate the superiority of preoperative cryoneurolysis versus no procedure, in patients operated on for knee arthroplasty and receiving standard analgesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 80 years;\n* Patient to undergo prosthetic knee surgery;\n* Patient in good health (ASA score 1 to 3);\n* Patient able to understand the information related to the study, read the information leaflet and agree to sign the consent form.\n\nExclusion Criteria:\n\n* Known intolerance to any of the products administered during surgery or cryoneurolysis;\n* Patient with an electric implant;\n* Patient with a contraindication to cryoanalgesia (coagulation disorders, infections, nerve damage);\n* Drug addict patient;\n* Intervention on septic bone;\n* Chronic renal failure (creatinine clearance \\<30 mL / min);\n* History of cryoglobulinemia, cold urticaria or Raynaud's syndrome;\n* Pregnant or breastfeeding woman;\n* Patient under guardianship or curatorship, or under a regime of deprivation of liberty;\n* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;\n* Patient not beneficiary of a social security scheme."}, 'identificationModule': {'nctId': 'NCT05059535', 'acronym': 'Cryogenou', 'briefTitle': 'Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Cryoneurolysis of the Saphenous Nerve or Geniculate Nerves: Impact on Postoperative Pain and Rehabilitation in Prosthetic Knee Surgery', 'orgStudyIdInfo': {'id': '2021-A01321-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cryoneurolysis of the saphenous nerve', 'description': 'A cryoneurolysis of the saphenous nerve will be performed between 7 days and 5 days before the knee arthroplasty', 'interventionNames': ['Drug: standard pain relievers']}, {'type': 'EXPERIMENTAL', 'label': 'cryoneurolysis of geniculate nerves', 'description': 'A cryoneurolysis of geniculate nerves will be performed between 7 days and 5 days before the knee arthroplasty', 'interventionNames': ['Drug: standard pain relievers']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'No cryoneurolysis will be performed before the knee arthroplasty', 'interventionNames': ['Drug: standard pain relievers']}], 'interventions': [{'name': 'standard pain relievers', 'type': 'DRUG', 'otherNames': ['Standard pain relievers in accordance with the current practice'], 'description': 'Knee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice', 'armGroupLabels': ['control', 'cryoneurolysis of geniculate nerves', 'cryoneurolysis of the saphenous nerve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94500', 'city': 'Champigny-sur-Marne', 'country': 'France', 'facility': "Hôpital privé Paul d'Egine", 'geoPoint': {'lat': 48.81642, 'lon': 2.49366}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'collaborators': [{'name': 'Euraxi Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}