Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-27 @ 4:10 PM
Study NCT ID:
NCT02476461
Status:
UNKNOWN
Last Update Posted:
2015-06-19
First Post:
2015-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004387', 'term': 'Dupuytren Contracture'}], 'ancestors': [{'id': 'D005350', 'term': 'Fibroma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003286', 'term': 'Contracture'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570746', 'term': 'xiapex'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-16', 'studyFirstSubmitDate': '2015-06-05', 'studyFirstSubmitQcDate': '2015-06-16', 'lastUpdatePostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'contracture size (degrees)', 'timeFrame': 'one year', 'description': 'contracture size mesured in degrees in each finger joint'}, {'measure': 'contracture size (degrees)', 'timeFrame': 'three years', 'description': 'contracture size mesured in degrees in each finger joint'}, {'measure': 'quick-Dash', 'timeFrame': 'one, three and five years', 'description': 'Quick-DASH functional score measured in points.'}, {'measure': 'Pain', 'timeFrame': 'one, three, five years', 'description': 'Visual Analogue score'}, {'measure': 'Hand disability', 'timeFrame': 'oen, three, five years', 'description': 'Visual Analogue score'}], 'primaryOutcomes': [{'measure': 'contracture size (degrees)', 'timeFrame': 'five years'}], 'secondaryOutcomes': [{'measure': 'contracture size', 'timeFrame': 'post treatment', 'description': 'Contracture size mesured in degrees in each finger joint'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['percutanepus needle fasciotomy', 'xiapex', 'clostridium histolyticum'], 'conditions': ['Dupuytrens Contracture']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether percutaneous needle fasciotomy is as effective for treating Dupuytrens contracture as Xiapex. Immidiate treatment effect is to be investigated, as iskontracture size after 5 years. Contracture size after one and three years, and subjective hand function is also to be investigated.', 'detailedDescription': 'Prospective randomized study between Percutanous Needle Fasciotomy and Xiapex for Dupuytrens contracture.\n\nA total of 50 patiens are to be randomized to eighter percutaneous needle fasciotomy or Xiapex treatment.\n\nThe patients randomized to xiapex treatment are treated as described in the product manual. Extentin treatment after one day.\n\nThe patients randomized to percutaneous needle fasciotomy are treated with the cutting teqnique: A littel quaddle local anestesia (xylocaine with adrenaline) is to be injected subcutant over the cord. After thet we use a 19G needle to cut the cord sufficient number sites to extend the finger.\n\nThe patients will be follwed up at 3 weeks, 3 months, 1 year, 3 years and 5 years. Investigators record contracture size, quicq-DASH, pain (VAS) and hand disability (VAS) pretreatment and at all controlls. At 3 weeks investigators register procedure complain. Side effects and complications, and advere effects are also to be investigated.\n\nOur hypothesis is that it is no difference between the two methods in regard of contracture size after five years.\n\nInclution criteria: Symptomatic primary Dupuytrens contracture with palpable cord in one to three fingers, involving MCP, and total contracture size is over 30 degrees. Patient age over 18 years.\n\nExclution criteria:\n\nPreviously treated Dupuytrens contracture in the same hand more than tree affected fingers we will not include thumbs Other symptomatic injury or disease influencingf hand function ASA\\>3 Expected lifetime less than five years tetracycline treatment within two weeks pregnancy nursing allergy to clostridium histolyticum concmittent other clinical trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic Dupuytrens contracture with palpable cord, involving MCP, total contracture size over 30 degrees\n\nExclusion Criteria:\n\n* previous treated dupuytrens contracture same hand\n* more than tree fingers involvement\n* we will not include thumbs\n* other things affecting hand function\n* ASA\\>3\n* expected to live under five years\n* Tetracycline treatment within two weeks\n* pregnancy\n* nursing\n* allergy to clostridium histolyticum\n* participant in other trial'}, 'identificationModule': {'nctId': 'NCT02476461', 'acronym': 'PNFvsxiapex', 'briefTitle': 'Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur', 'orgStudyIdInfo': {'id': '1234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'xiapex', 'description': '1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual', 'interventionNames': ['Drug: xiapex']}, {'type': 'EXPERIMENTAL', 'label': 'PNF', 'description': 'percutaneous needle fasciotomi is performed at affected cords', 'interventionNames': ['Procedure: percutaneous needle fasciotomy']}], 'interventions': [{'name': 'xiapex', 'type': 'DRUG', 'otherNames': ['clostridium histolyticum'], 'armGroupLabels': ['xiapex']}, {'name': 'percutaneous needle fasciotomy', 'type': 'PROCEDURE', 'otherNames': ['PNF'], 'armGroupLabels': ['PNF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'state': 'Oslo County', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'hallgeir bratberg, MD', 'role': 'CONTACT', 'email': 'hbratbe@ous-hf.no', 'phone': '+4790578848'}], 'facility': 'Oslo Universitetssykehus', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'hallgeir bratberg, MD', 'role': 'CONTACT', 'email': 'hbratber@ous-hf.no', 'phone': '+4790578848'}], 'overallOfficials': [{'name': 'hallgeir bratberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}