Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-25 @ 9:07 PM
Study NCT ID:
NCT01358292
Status:
COMPLETED
Last Update Posted:
2016-06-17
First Post:
2011-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013978', 'term': 'Tibial Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-16', 'studyFirstSubmitDate': '2011-01-14', 'studyFirstSubmitQcDate': '2011-05-20', 'lastUpdatePostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anterior Knee Pain', 'timeFrame': '4, 6 and 12 months post-operative', 'description': 'Anterior Knee pain will be measured through a Kneeling test (time a patient is able to rest on his operated knee)'}], 'secondaryOutcomes': [{'measure': 'Nail positioning', 'timeFrame': 'Operation (day 1)', 'description': 'Measure by means of fluoroscopy and standard x-rays during the surgery, the position of both the guide wire and the intramedullary nail.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intramedullary tibia nailing', 'Anterior Knee Pain', 'Nail positioning'], 'conditions': ['Tibial Fractures']}, 'descriptionModule': {'briefSummary': "Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for extra-articular tibial fractures treated with Smith\\& Nephew's Trigen META intramedullary nailing system; comparing two surgical techniques: Group A=standard technique(90º of knee flexion) and Group B=with the semi-extended surgical technique. (2\\*100 patients)\n\nResearch Objectives:\n\nThe primary research objectives are to evaluate:\n\ni) anterior knee pain and ii) the nail position and overall fracture alignment\n\nOutcome Measures:\n\n1. Nail positioning by means of intra-operative fluoroscopy and post operative x-rays.\n2. Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by means of Patient questionnaires\n3. Knee-related adverse events\n4. Overall fracture alignment", 'detailedDescription': 'After surgery with standard intramedullary nailing technique in tibia fractures, 40-80% of the patients still complain of anterior knee pain postoperative. The expected advantages of the semi-extended nailing technique is less anterior knee pain and less malunion of the fracture.\n\nUsing the semi-extended nailing technique also might give the advantage of better position of the nail by a more concentric reaming of the tibia, due to less tension on the patella tendon during reaming process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has sustained a closed (Tscherne Classification) or open tibial fracture (Gustillo-Anderson Classification) that is amendable for operative fixation with an intramedullary nail.\n* Patient has an isolated tibia and fibula fracture\n* Skeletally mature\n* Patients aged between/including 18 to 70 years\n* Patient has given formal consent to be involved in the trial and has completed the study consent form\n* Patient is likely to comply with study follow-up requirements\n\nExclusion Criteria:\n\n* Pathologic fractures\n* Other fractures involving the same lower extremity\n* Soft tissue injuries/problems that would prevent the surgeon from using both of the surgical techniques to insert an intramedullary nail\n* Patient having pre-existing knee joint disease causing anterior knee pain\n* Patient likely to have problems with follow-up\n* Patient unwilling to give informed consent to be included in the trial'}, 'identificationModule': {'nctId': 'NCT01358292', 'acronym': 'TrigenMETA', 'briefTitle': 'Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'Semi-extended Position vs. 90 Degrees of Flexion for Intramedullary Nailing of the Tibia: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'R11021-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semi-extended surgical technique', 'description': 'The experimental technique for implanting an intramedullary tibia nail is with the knee in 10-20 degrees of flexion.', 'interventionNames': ['Procedure: Semi-extended Surgical Technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Surgical Technique', 'description': 'The standard surgical technique in intramedullary tibia nailing is with the knee in almost 90 degrees of flexion.', 'interventionNames': ['Procedure: Standard Surgical Technique']}], 'interventions': [{'name': 'Semi-extended Surgical Technique', 'type': 'PROCEDURE', 'otherNames': ['Trigen META Intramedullray Tibia Nail'], 'description': 'Surgical technique with the knee in 10-20 degrees of flexion, to implant the intramedullary tibia nail.', 'armGroupLabels': ['Semi-extended surgical technique']}, {'name': 'Standard Surgical Technique', 'type': 'PROCEDURE', 'otherNames': ['Trigen META intramedullary tibia nailing'], 'description': 'Th e Standard surgical techique is implanting the tibia nail with the knee in 90 degrees of flexion.', 'armGroupLabels': ['Standard Surgical Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52146', 'city': 'Würselen', 'country': 'Germany', 'facility': 'Medizinisches Zentrum StädteRegion Aachen', 'geoPoint': {'lat': 50.81809, 'lon': 6.1347}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hoisptal de 12 Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Alan Johnstone, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aberdeen Royal Infirmary'}, {'name': 'Pedro Caba, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital de 12 Octubre, Madrid'}, {'name': 'Markus Graf, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Medizinisches Zentrum StädteRegion Aachen'}, {'name': 'Ismael Escriba, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital La Fe de Valencia'}, {'name': 'Daren Forward, MA, FRCS, DM', 'role': 'STUDY_CHAIR', 'affiliation': 'Nottingham University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew Orthopaedics AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}