Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-28 @ 6:12 AM
Study NCT ID:
NCT01128868
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2010-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proximal Femur Locking Compression Plates Versus Trochanteric Nails
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Canada', 'Germany', 'United States']}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2010-05-20', 'studyFirstSubmitQcDate': '2010-05-21', 'lastUpdatePostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the functional outcome and abductor muscle strength measured with Lafayette Manual Muscle Tester in patients with reverse oblique inter- or subtrochanteric fractures treated either with a proximal femur locking plate or a trochanteric nail.', 'timeFrame': 'one year', 'description': 'As hip abductors are the most important muscles around the hip joint, the primary outcome parameter will involve objectively measuring hip abductor strength. Muscle strength will be assessed with a portable handheld dynamometer (Model 01163, Lafayette Instrument Company, Lafayette, IN, USA).'}], 'secondaryOutcomes': [{'measure': 'Patient outcome', 'timeFrame': 'one year', 'description': 'Patient outcome will be measured using the following outcome measurements:\n\nMobility measured with the "timed up \\& go"-test (TUG), Lower Extremity Measure (LEM) for functional outcome, Length of hospital stay, Walking ability (Parker Mobility Score), Capacity to return to pre-residential status, Quality of life (Short Form-36 \\[SF-36\\]), Mortality.'}, {'measure': 'Pain scores on the Visual Analog Scale', 'timeFrame': 'one year', 'description': 'Pain will be measured with the Visual Analogue Scale (VAS) (additionally assessed in a subgroup with the Brief Pain Inventory \\[BPI\\]).'}, {'measure': 'Patient satisfaction with the Visual Analogue Scale', 'timeFrame': 'one year', 'description': 'Satisfaction measured with the VAS'}, {'measure': 'Abductor muscle function with the Trendelenburg sign analysis', 'timeFrame': 'one year', 'description': 'Abductor muscle function test'}, {'measure': 'Surgical details', 'timeFrame': 'Initial hospitalization', 'description': 'Skin-to-skin time, Fluoroscopy time, Blood loss, Blood transfusions, Surgeons experience.'}, {'measure': 'Local complications', 'timeFrame': 'one year', 'description': 'Local complication will be recorded and categorized:\n\nImplant / surgery complications, Bone / fracture complications, Soft tissue / wound complications.'}, {'measure': 'Revision rate', 'timeFrame': 'one year', 'description': 'Surgical revision includes all secondary surgical interventions that are related to the injury itself or the primary intervention. It is distinguished from planned revisions due to the injury (eg, planned soft tissue procedure) and revisions due to a complication. Revisions due to a complication are undertaken to resolve the problem and will therefore be documented in the complication form.'}, {'measure': 'Systemic or general complications', 'timeFrame': 'one year', 'description': 'All complications affecting other regions of the body will be documented and evaluated as general/systemic complications, eg, thromboembolic complications, sepsis and others.'}, {'measure': 'Exploration of prognostic factors for the occurrence of complications, using the Fracture Risk Assessment Tool (FRAX)', 'timeFrame': 'Initial hospitalization', 'description': 'Fracture risk prior to injury will be calculated with the Fracture Risk Assessment Tool \\[FRAX\\] (http://www.shef.ac.uk/FRAX/index.htm).\n\nAdditionally, the fracture risk will be considered as a prognostic factor (in the absence of regular BMD measurements) for the analysis of complications.'}, {'measure': 'Quality of reduction', 'timeFrame': 'one year', 'description': 'The results of fracture reduction are assessed with the following clinical and radiological evaluations : Varus/valgus deformity, Endo-/exorotation deformity, Limb length.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Reverse oblique intertrochanteric fractures', 'Reverse oblique subtrochanteric fractures'], 'conditions': ['Reverse Oblique Intertrochanteric Fractures', 'Reverse Oblique Subtrochanteric Fractures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the abductor muscle strength measured with a dynamometer in patients with reverse oblique inter- or subtrochanteric fractures treated either with a proximal femur locking plate or a trochanteric nail.\n\n"Proximal femur locking plates" stands for both the PF-LCP (Synthes) and the PeriLoc (Smith \\& Nephew). Trochanteric nails allowed in this study are the Proximal Femoral Nail Antirotation (PFNA), the Titanium Trochanteric Fixation Nail (TFN) and the Gamma Nail (GN).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients with closed or type 1 open reverse oblique intertrochanteric fractures (AO 31 - A3) or subtrochanteric fractures (transverse fracture line, main fracture line maximum 5 cm distal from the lesser trochanter; proximal extension of fracture allowed)\n* Definitive fracture fixation with either a proximal femur locking plate or an intertrochanteric nail within 4 days after accident\n* Signed written informed consent (by the subject or legal guardian) and agreement to attend the planned FUs\n* Able to understand and read country national language at an elementary level\n\nExclusion Criteria:\n\n* Pathologic fracture\n* Polytrauma\n* Any displacement of a femoral neck fracture\n* Additional fracture of one of the lower extremities that significantly affects the functional outcome\n* Additional injury of the lower limb that significantly affects the functional outcome\n* Fractures of the upper extremity if it affects the mobility of the patient\n* Type 2 or 3 open fracture\n* Drug or alcohol abuse\n* Active malignancy\n* ASA class V and VI\n* Inability to walk independently prior to injury\n* Neurological and psychiatric disorders that would preclude reliable assessment\n* Patient is not able to come to the regular FUs\n* Patients who have participated in any other device or drug related clinical trial within the previous month\n* Pregnancy (tested with a urine pregnancy test) or women planning to conceive within the study period'}, 'identificationModule': {'nctId': 'NCT01128868', 'briefTitle': 'Proximal Femur Locking Compression Plates Versus Trochanteric Nails', 'organization': {'class': 'OTHER', 'fullName': 'AO Innovation Translation Center'}, 'officialTitle': 'Treatment of Reverse Oblique Intertrochanteric or Subtrochanteric Fractures With a Proximal Femur Locking Compression Plate (PF-LCP, PF-LCP Hook Plate, PeriLoc) or Trochanteric Nails. A Multicenter Cohort Study', 'orgStudyIdInfo': {'id': 'PF LCPs vs Trochanteric Nail'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Proximal femur locking plate', 'description': 'Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with a Proximal Femur Locking Compression Plate (PF-LCP, PF-LCP Hook Plate, PeriLoc)', 'interventionNames': ['Device: Proximal femur locking plate']}, {'type': 'OTHER', 'label': 'Trochanteric nail', 'description': 'Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with Trochanteric Nails (PFNA, TFN, GN)', 'interventionNames': ['Device: Intertrochanteric nail']}], 'interventions': [{'name': 'Proximal femur locking plate', 'type': 'DEVICE', 'otherNames': ['LCP Proximal Femur Plate (Synthes)', 'LCP Proximal Femur Hook Plate (Synthes)', 'PeriLoc Periarticular Locked Plating System (Smith & Nephew)'], 'description': 'Proximal femur locking plate (PF-LCP, PF-LCP Hook Plate, Periloc)', 'armGroupLabels': ['Proximal femur locking plate']}, {'name': 'Intertrochanteric nail', 'type': 'DEVICE', 'otherNames': ['Proximal Femoral Nail Antirotation (Synthes)', 'Titanium Trochanteric Fixation Nail (Synthes)', 'Gamma Trochanteric Nail (Stryker)'], 'description': 'Intertrochanteric nail (PFNA, TFN, GN)', 'armGroupLabels': ['Trochanteric nail']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '7000', 'city': 'Chur', 'country': 'Switzerland', 'facility': 'Cantonal Hospital Chur', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}, {'zip': '6000', 'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Cantonal Hospital Lucerne', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}], 'overallOfficials': [{'name': 'Beate P. Hanson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AO Clinical Investigation and Documentation, Davos, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AO Clinical Investigation and Publishing Documentation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}