Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT01341418
Status:
COMPLETED
Last Update Posted:
2017-02-14
First Post:
2011-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-13', 'studyFirstSubmitDate': '2011-04-20', 'studyFirstSubmitQcDate': '2011-04-22', 'lastUpdatePostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'residual postoperative knee pain', 'timeFrame': '1 year', 'description': 'A Visual Analog Scale (VAS) will be used for knee pain, as well as a pain location diagram and a Lysholm knee score.'}], 'secondaryOutcomes': [{'measure': 'union/alignment of tibia', 'timeFrame': '3 months postoperatively', 'description': 'AP and lateral radiographs will be used to evaluate union/alignment of the tibia.'}, {'measure': 'knee function', 'timeFrame': '6 months postoperatively', 'description': 'A Lysholm knee score will be used to evaluate knee function, as well as range of motion (ROM) measurements.'}, {'measure': 'trochlear changes in the patello-femoral cartilage', 'timeFrame': '1 year', 'description': 'Pre- and post-nailing arthroscopic photos and an MRI at 12 months postoperative will be used to evaluate trochlear changes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tibia', 'suprapatellar'], 'conditions': ['Tibial Fractures']}, 'referencesModule': {'references': [{'pmid': '20926959', 'type': 'BACKGROUND', 'citation': 'Gelbke MK, Coombs D, Powell S, DiPasquale TG. Suprapatellar versus infra-patellar intramedullary nail insertion of the tibia: a cadaveric model for comparison of patellofemoral contact pressures and forces. J Orthop Trauma. 2010 Nov;24(11):665-71. doi: 10.1097/BOT.0b013e3181f6c001.'}]}, 'descriptionModule': {'briefSummary': 'This study compares two techniques for the fixation of tibial fractures. The techniques are the suprapatellar (above knee)or infrapatellar (below knee) approach to tibial intramedullary nailing. Null hypothesis: There is no difference in 1) residual post-operative pain levels, 2)knee function, 3) healing and alignment of the tibia, or 4) trochlear changes in the patello-femoral cartilage between patients who are randomized to receive tibial nail insertion through either a suprapatellar nail entry portal or a standard patellar tendon approach.', 'detailedDescription': 'Patients undergoing tibial fracture repair will be consented and randomized into one of the two techniques, with arthroscopic photos taken before and after nail insertion to study the condition of the patello-femoral cartilage. Enrolled patients will be followed for one year in clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tibial shaft fractures amenable and indicated for repair with intramedullary nails, with or without the use of reaming\n* Acute tibial fractures within 4 weeks of injury\n* Closed or open tibial fractures after appropriate irrigation and debridement\n* Fractures must be within metaphyseal/diaphyseal junctures defined as middle 3/5 of tibia\n* Skeletally mature patient\n* Age 18 and above.\n\nExclusion Criteria:\n\n* Tibial shaft fractures that require articular reconstruction with plates\n* Any tibial fracture extending \\> 1 cm into the proximal or distal 1/5 of tibia\n* Tibial plateau fractures\n* Pilon fractures\n* Periprosthetic fractures\n* Non-unions\n* Prior knee surgery\n* History of gout or rheumatoid or osteoarthritis\n* Concomitant injury to same limb (including any traumatic injury to ipsilateral knee, femur or foot, and knee dislocation)\n* Spinal injury\n* Prisoner or high likelihood of incarceration\n* Not likely to follow-up in the estimation of surgeon\n* Pregnant females'}, 'identificationModule': {'nctId': 'NCT01341418', 'acronym': 'SP-Pilot', 'briefTitle': 'Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study', 'organization': {'class': 'NETWORK', 'fullName': 'Florida Orthopaedic Institute'}, 'officialTitle': 'Randomized Clinical Trial of Suprapatellar Versus Infrapatellar Tibial Nailing: A Pilot Study', 'orgStudyIdInfo': {'id': 'SP-2676-3103'}, 'secondaryIdInfos': [{'id': 'OTA 39', 'type': 'OTHER_GRANT', 'domain': 'Orthopaedic Trauma Association'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Suprapatellar approach', 'description': 'surgical approach for intramedullary nailing of the tibia', 'interventionNames': ['Procedure: Suprapatellar approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infrapatellar approach', 'description': 'surgical approach for intramedullary nailing of the tibia', 'interventionNames': ['Procedure: Infrapatellar approach']}], 'interventions': [{'name': 'Suprapatellar approach', 'type': 'PROCEDURE', 'otherNames': ['semi-extended approach'], 'description': 'Suprapatellar surgical approach will be used for intramedullary nailing of tibial fractures. Arthroscopic photos will be obtained before and after nail insertion. Postoperative radiographs, outcome questionnaires and an MRI will be performed over ther course of one-year follow-up.', 'armGroupLabels': ['Suprapatellar approach']}, {'name': 'Infrapatellar approach', 'type': 'PROCEDURE', 'otherNames': ['standard tibial nailing approach'], 'description': 'The Infrapatellar surgical approach will be used for intramedullary nailing of tibial fractures. No arthroscopic examination for this intervention. Postoperative radiographs, outcome questionnaires and an MRI will be performed over ther course of one-year follow-up.', 'armGroupLabels': ['Infrapatellar approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'St. Josephs Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Roy W Sanders, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Orthopaedic Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida Orthopaedic Institute', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Orthopaedic Trauma Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}