Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-02 @ 5:00 AM
Study NCT ID:
NCT04372251
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-09
First Post:
2020-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The investigators that will conduct the follow-up examinations 2 and 5 years after surgery will be blinded for the operative treatment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm parallel assignment. Patients er randomized to operative treatment with either the sinus tarsi approach or percutaneous and arthroscopically assisted osteosynthesis.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-04-29', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Manchester-Oxford Foot Questionnaire (MOxFQ)', 'timeFrame': '5 years', 'description': 'Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)'}], 'secondaryOutcomes': [{'measure': 'American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score', 'timeFrame': '5 years', 'description': 'Widely used foot/ankle score (0-100 with 100 representing the best possible outcome)'}, {'measure': 'Calcaneus Fracture Scoring System (CFSS)', 'timeFrame': '5 years', 'description': 'Calcaneal fracture specific scoring system (0-100 with 100 representing the best possible outcome)'}, {'measure': 'Self-reported foot and ankle score (SEFAS)', 'timeFrame': '5 years', 'description': 'Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)'}, {'measure': 'Visual Analogue Scale (VAS) for pain', 'timeFrame': '5 years', 'description': 'Scores pain at rest and on activity (0-10 with 0 representing no pain)'}, {'measure': 'Incidence of complications', 'timeFrame': '5 years', 'description': 'Yes/no for deep or superficial infection, nerve or tendon injury, deep venous thrombosis, hardware complaints and secondary surgery'}, {'measure': 'Böhler angle', 'timeFrame': '5 years', 'description': 'Böhler angle pre- and post surgery as well as at follow up'}, {'measure': 'Subtalar osteoarthritis', 'timeFrame': '5 years', 'description': 'The presence of subtalar osteoarthritis is graded based CT scans taken at the 2 year and 5 year follow-up using the Kellgren \\& Lawrence classification system.'}, {'measure': 'EQ-5D-5L', 'timeFrame': '5 years', 'description': 'Measure of health-related quality of life. This will be evaluated at the 2-year and 5 -year follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Calcaneal fracture', 'Subtalar arthroscopy', 'Trauma', 'Calcaneus'], 'conditions': ['Calcaneus Fracture']}, 'descriptionModule': {'briefSummary': 'In this randomized controlled trial, the outcomes of two surgical techniques for intraarticular calcaneal fractures will be evaluated and compared.', 'detailedDescription': 'Operative treatment of calcaneal features through an extensile lateral approach (ELA) has been the gold standard over many years despite high rates of infection and soft tissue complications.\n\nLately, there has been a trend towards less invasive fixation methods. Minimally invasive plate osteosynthesis using the sinus tarsi approach (STA) has gained popularity during the last decade.\n\nFurthermore, percutaneous reduction and fixation techniques have been described and used for a few decades. In the early 2000s, Rammelt et al. were the first who introduced a percutaneous technique assisted by hindfoot arthroscopy. The percutaneous and arthroscopically assisted calcaneal osteosynthesis (PACO) is applicable in Sanders II and III fractures and has been shown to provide good clinical outcomes as well as a low rate of complications.\n\nThe study is designed as a superiority study. Our hypothesis is that the percutaneous and arthroscopically assisted technique provides superior outcomes compared to the sinus tarsi approach in Sanders II and III calcaneal fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dislocated intraarticular calcaneal fracture, type Sanders II or Sanders III with an intraarticular step \\> 2mm\n* Patients between 18 and 70 years of age\n* Acute presentation at one of our departments, enabling surgery within 10 days after injury\n\nExclusion Criteria:\n\n* Intraarticular step of \\< 2mm\n* Sanders IV fractures\n* Open fractures\n* Bilateral injuries\n* Concomitant major injuries of the foot, ankle or leg that affect the rehabilitation process\n* Multitraumized patients\n* Previous injury or surgery of the hindfoot\n* Charcot foot\n* Serious medical condition that contradicts surgery\n* Noncompliant patients\n* Insufficient Norwegian or English language skills\n* Patients not available for follow-up\n* Inability to conduct the rehabilitation protocol'}, 'identificationModule': {'nctId': 'NCT04372251', 'briefTitle': 'Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach', 'organization': {'class': 'OTHER', 'fullName': 'Ostfold Hospital Trust'}, 'officialTitle': 'Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach - A Randomized Controlled Multicenter Trial', 'orgStudyIdInfo': {'id': '20/00912'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sinus tarsi approach (STA)', 'description': 'Patients randomized to this arm are operated with plate osteosynthesis via the sinus tarsi approach', 'interventionNames': ['Procedure: Sinus tarsi approach (STA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)', 'description': 'Patients randomized to this arm are operated with percutaneous reduction of the fracture and osteosynthesis with screws, assisted by subtalar arthroscopy', 'interventionNames': ['Procedure: Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)']}], 'interventions': [{'name': 'Sinus tarsi approach (STA)', 'type': 'PROCEDURE', 'description': 'Osteosynthesis', 'armGroupLabels': ['Sinus tarsi approach (STA)']}, {'name': 'Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)', 'type': 'PROCEDURE', 'description': 'Osteosynthesis', 'armGroupLabels': ['Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Drammen', 'country': 'Norway', 'facility': 'Vestre Viken Hospital Trust - Drammen hospital', 'geoPoint': {'lat': 59.74389, 'lon': 10.20449}}, {'zip': '0588', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo university hospial', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Sandvika', 'country': 'Norway', 'facility': 'Vestre Viken Hospital Trust - Bærum hospital', 'geoPoint': {'lat': 64.46377, 'lon': 13.59125}}, {'zip': '1714', 'city': 'Sarpsborg', 'state': 'Østfold fylke', 'country': 'Norway', 'facility': 'Østfold Hospital Trust', 'geoPoint': {'lat': 59.28391, 'lon': 11.10962}}], 'overallOfficials': [{'name': 'Are Stødle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}, {'name': 'Frede Frihagen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ostfold Hospital Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ostfold Hospital Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oslo University Hospital', 'class': 'OTHER'}, {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, {'name': 'Vestre Viken Hospital Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}