Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-06-21 @ 4:12 PM
Study NCT ID:
NCT03945669
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2019-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intramedullary Nailing vs External Ring Fixation for the Treatment of Tibial Shaft Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005594', 'term': 'Fracture Fixation, Intramedullary'}], 'ancestors': [{'id': 'D005593', 'term': 'Fracture Fixation, Internal'}, {'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Due to the nature of the study participants, care providers and investigator can not be blinded. The outcome assessor will be blinded with regards to the two treatment groups.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2019-05-03', 'studyFirstSubmitQcDate': '2019-05-09', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': '6 weeks, 3+6+12 months', 'description': 'Adverse events, defined as any negative or unwanted reactions to the two surgical procedures, will be recorded. These will include deep infection, pin infection, skin infections, malalignment, compartment syndrome or any other reported physical discomfort. An adverse effects committee will manage adverse reactions at the time of the adverse reaction.'}], 'primaryOutcomes': [{'measure': 'The Knee Injury and Osteoarthritis Outcome Score - sport (KOOS Sport)', 'timeFrame': '12 month follow up', 'description': 'KOOS-sport is a standardized and validated patient-reported instrument used in order to assess knee and knee associated problems with regards to activity. The subscale sport is one five subscales: pain, ADL, symptoms, sport and QOL in the KOOS questionnaire . A total score of 100 indicates no symptoms, and 0 indicates major symptoms.'}], 'secondaryOutcomes': [{'measure': 'Perceived Pain', 'timeFrame': '6 weeks, 3+6+12 months', 'description': 'Development in pain in the two groups will be recorded by patient-reported pain intensity measured on a 10 cm visual analogue scale (VAS) with endpoints "no pain" and "maximal pain" for the worst pain during the last 24 hours and resting pain.'}, {'measure': 'Patient-reported pain reactions', 'timeFrame': '6 weeks, 3+6+12 months', 'description': 'Pain DETECT questionnaire. The painDETECT screening questionnaire (PD-Q), uses a scoring method between - 1 and 38 to estimate the likelihood of a neuropathic pain component in patients.'}, {'measure': 'Pain sensitivity', 'timeFrame': '6 weeks, 3+6+12 months', 'description': 'Pain sensitivity will be assessed by pressure pain thresholds (PPTs) recorded by handheld pressure algometry (Algometer Type II, Somedic AB, Sweden).'}, {'measure': 'Muscle strength', 'timeFrame': '6+12 months', 'description': 'Isometric muscle strength in the two groups will be measured by a strap-mounted dynamometer attached to the wall (Mecmesin AFG2500, Mecmesin Ltd, West Sussex, UK). Girth measures of thigh and calf will be used to examine muscle atrophy and/or effusion'}, {'measure': 'Time to bone union', 'timeFrame': '6 weeks, 3+6+12 months', 'description': 'Bone union, in the two surgical groups will be evaluated on standard AP and side X-rays of the fractured leg. The evaluation of bone union will be defined as: i) visible callus formation on at least three of four sides, no visible fracture line and no pain from fracture site at weight-bearing and during clinical examination.'}, {'measure': 'Radiological alignment', 'timeFrame': '6 weeks, 3+6+12 months', 'description': 'Alignment of the tibia will be evaluated using the EOS scanning system.'}, {'measure': 'Health related QOL', 'timeFrame': '6 weeks, 3+6+12 months', 'description': "Eq5D-5L is a standardized questionnaire developed to assess general health outcome (29). It consists of five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a self-rated health scale on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. An Eq5d-5L index of 1.0 indicated full health, 0 death, and -0.59 denoted a condition worse than death"}, {'measure': 'Time to return to work', 'timeFrame': '6 weeks, 3+6+12 months', 'description': 'Measure the time from surgery to end of sick leave measured in days.'}, {'measure': 'Health economic evaluation', 'timeFrame': '12 months', 'description': 'Measure the cost of treatment in the two groups within the first year following surgery'}, {'measure': 'Gait assessment', 'timeFrame': '3+6+12 months', 'description': 'Gait asymmetries will be measured with patients walking on a pressure-sensitive mat.'}, {'measure': 'Patient Acceptable Symptom State (PASS)', 'timeFrame': '3+6+12 months', 'description': 'This instrument evaluate when the patient reaches a acceptable patient observed pain and function level, where the patient no longer demands treatment'}, {'measure': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': '6 weeks, 3+6+12 months', 'description': 'KOOS is a standardized and validated patient-reported instrument used in order to assess knee and knee associated problems.The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.'}, {'measure': 'Foot And Ankle Outcome Score (FAOS)', 'timeFrame': '6 weeks, 3+6+12 months', 'description': 'FAOS is a standardized and validated patient-reported instrument used in order to assess foot and ankle associated problems divided into 5 subscales. The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['External ring fixation', 'Intramedullary nailing', 'Tibial shaft fracture', 'patient reported outcome'], 'conditions': ['Tibial Shaft Fracture']}, 'referencesModule': {'references': [{'pmid': '40679543', 'type': 'DERIVED', 'citation': 'Larsen P, Stokholm R, Rolfing JD, Petruskevicius J, Rasmussen MK, Jensen SS, Elsoe R. Intramedullary nailing versus external ring fixation for tibial shaft fractures: an explorative analysis of muscle strength from the IMVEX trial. Arch Orthop Trauma Surg. 2025 Jul 18;145(1):379. doi: 10.1007/s00402-025-05995-6.'}]}, 'descriptionModule': {'briefSummary': 'This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial in which standard intramedullary nailing is compared with external ring fixator for patients with tibial shaft fractures.', 'detailedDescription': 'This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial in which standard intramedullary nailing is compared with external ring fixator for patients with tibial shaft fractures.\n\nThe primary aim of the project is to compare the one-year Knee Injury and Osteoarthritis Outcome Score - Sport (KOOS-Sport) after standard intramedullary nailing with external ring fixation for patients with tibial shaft fractures.\n\nThe explorative aim is to report the effect of the two surgical procedures on the development of complications, time to bone union, pain reactions, muscle strength, activity of daily living and time to return to work.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fracture of the tibial shaft\n* OTA classification Type: 42-A1-A3, -B1-B3 and -C1-C3\n* The fracture type is deemed operable by intramedullary nail\n\nExclusion Criteria:\n\n* Below 18 years of age\n* Open fracture\n* History of severe systemic diseases or cancer\n* Bilateral tibial shaft fracture\n* Multi fracture patients\n* Pregnancy\n* Patients without gait function prior to fracture'}, 'identificationModule': {'nctId': 'NCT03945669', 'acronym': 'IMVEX', 'briefTitle': 'Intramedullary Nailing vs External Ring Fixation for the Treatment of Tibial Shaft Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Intramedullary Nailing Versus External Ring Fixation for Surgical Treatment of Tibial Shaft Fractures in Adults and Their One Year Outcome on Recovery: Study Protocol for a Pragmatic Randomized Controlled Trial (The IMVEX Trial)', 'orgStudyIdInfo': {'id': 'LERG1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intramedullary Nail', 'description': 'Intramedullary Nailing: Alignment will be obtained by closed or limited open reduction of the fracture. A standard reamed intramedullary nail is inserted. Access above the patella, through the patella tendon or parapatellar access is used according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. Patients are administered preoperative antibiotics (Dicloxacillin) 15 minutes before surgery commences. Postoperative antibiotics is administered by discretion of the surgeon based on individual patient considerations.', 'interventionNames': ['Procedure: Intramedullary Nailing']}, {'type': 'EXPERIMENTAL', 'label': 'External Ring fixator', 'description': 'External Ring fixation: Closed or limited open reduction of the fracture is performed. A circular frame is attached on both sides of the fracture. Connection to the bone is obtained by hydroxyapatite coated half pins and/or k-wires with olives as needed according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. After applying the ring fixator alignment is assessed radiologically and corrected both peri- and postoperatively. Patients are administered preoperative antibiotics (Dicloxacillin) preoperatively 15 minutes before surgery commences. Following surgery antibiotics are continued until wounds, pin- and wire perforations are dry.', 'interventionNames': ['Procedure: External Ring fixation']}], 'interventions': [{'name': 'Intramedullary Nailing', 'type': 'PROCEDURE', 'description': 'fracture fixation of the tibial shaft fracture with an intramedullary nail.', 'armGroupLabels': ['Intramedullary Nail']}, {'name': 'External Ring fixation', 'type': 'PROCEDURE', 'description': 'fracture fixation of the tibial shaft fracture with an external ring fixator.', 'armGroupLabels': ['External Ring fixator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University Hospital, Department of orthopaedic surgery', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '8800', 'city': 'Viborg', 'country': 'Denmark', 'facility': 'Regional Hospital Viborg', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}], 'overallOfficials': [{'name': 'Rasmus Elsøe, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aalborg University Hospital'}, {'name': 'Rasmus Stokholm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University Hospital'}, {'name': 'Peter Larsen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Council for Independent Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Orthopaedic trauma', 'investigatorFullName': 'Rasmus Elsøe', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}