Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-02-20 @ 10:44 AM
Study NCT ID:
NCT03906032
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2019-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Simple randomization technique using an online random number generator will be utilized. Sequential sealed envelopes with group allocation will be opened at the time of the daily trauma meeting and the appropriate plan made for the patient. Patients are randomized according to 3 mobility groups - independent, walking stick/crutch or walking frame.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Gait speed (mean velocity): Sample size calculations are based on a two-sample, two-sided t-test for a difference in means with 80% power, a 5% type 1 error rate. The minimal clinically important difference (MCID) in gait speed is stated in the literature as between 0.10 - 0.20 m/s. We considered treatment effect of 0.2 m/s (while assuming a SD of 0.3). The resulting total sample sizes for this effect is 74 patients at the 6 months post-operative timeframe. A significant attrition rate (50%) for this population will be allowed for by additional recruitment of \\>150 participants'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2019-04-01', 'studyFirstSubmitQcDate': '2019-04-05', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kinmeatic Gait parameters at Hip', 'timeFrame': '6 months', 'description': 'Rate of change in hip kinematic profile between baseline and subsequent time points,'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'Through to study completion at one year post operatively.', 'description': 'The duration of hospital stay after this procedure has wide variability between 3 days and weeks to months.'}, {'measure': 'Change in Heamoglobin concentration post surgery', 'timeFrame': 'Day 2 post surgery', 'description': 'Haemoglobin (Hb) day two measurement in grams per decilitre (g/dl)'}, {'measure': 'Change in Heamatocrit concentration post surgery', 'timeFrame': 'Day 2 post surgery', 'description': 'Haematocrit day two measurement in litre of cells per litre of blood (L/L)'}, {'measure': 'Mortality', 'timeFrame': 'At any time point to 1 year post op', 'description': 'Absolute'}, {'measure': 'Analgesia Use', 'timeFrame': '5 days', 'description': 'rate of opiate use'}, {'measure': 'Timed up and go test', 'timeFrame': '6 weeks, 6 months, 1 year', 'description': 'Tested measure of mobility and the change between baseline and subsequent time points'}, {'measure': 'Harris Hip score', 'timeFrame': '6 weeks, 6 months, 1 year', 'description': 'Functional scale of hip pain and the change between baseline and subsequents time points. Maximum score: 100 points indicating excellent function, minimum score 0 points indicating poor function'}, {'measure': 'Radiographic assessment of fracture healing', 'timeFrame': '6 weeks, 6 months, 1 year', 'description': 'Radiographic union as observed on plain radiographs at the stated time intervals (radiographic union score for hip total score of 10 - 30 points, minimum 10, maximum 30)'}, {'measure': 'Radiographic assessment of femoral neck shortening', 'timeFrame': '6 months', 'description': 'Radiographic assessment of any change in femoral neck length (in millimetres) between image on date of surgery and the 6 month post surgery image'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Timed up and go', 'mobility', 'functional outcome'], 'conditions': ['Hip Fractures', 'Gait, Unsteady', 'Function']}, 'descriptionModule': {'briefSummary': 'Shortening of the abductor lever arm is a particular concern with the SHS, and the resultant biomechanical alterations may impair gait, including decreased cadence, gait speed and increased double support time on the injured side.\n\nThe use of an IM nail device may reduce shortening and improve functional parameters in this patient cohort', 'detailedDescription': 'Published work in this field to date has not demonstrated an advantage of nailing over hip screw in intertrochanteric proximal femoral fractures. The current literature focus on outcome questionnaires, pain scores and basic functional tests alone may not delineate all functional benefits. A key factor in whether a person, post hip fracture, returns to independent living is gait speed. The cost implications on the healthcare provider of having 30% of this ever increasing group losing their independence and requiring admission to a care facility post hip fracture is a growing problem.\n\nShortening of the abductor lever arm is a particular concern with the SHS, and the resultant biomechanical alterations may impair gait, including decreased cadence and increased double support time on the injured side.\n\nThe cost differential between a nail and a SHS is a barrier to routine use of nailing in this population unless a clear benefit is demonstrated. Fracture nonunion is uncommon in this injury however improving functional outcome and reducing morbidity and mortality in this group is important.\n\nIn this prospective randomised study, the investigators examine whether an intramedullary nail (TFNA) results in a greater functional benefit in A1/A2 intertrochanteric fractures compared with the SHS, in terms of gait speed and other objective gait assessments, as well as other established post operative outcome measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* OTA Hip fracture grade A1 and A2\n* Greater than 18 years old\n\nExclusion Criteria:\n\n* Fracture less than 18 yrs old\n* Fracture with lateral wall trochanteric comminution\n* Poltrauma\n* Concurrent lower limb fractures\n* Immobile/wheelchair/bedbound patients\n* High energy hip fractures\n* Pathological fractures\n* Reverse oblique and sub-trochanteric femoral fractures which are considered obligate TFNA at our centre\n* Open wounds on affected limb\n* Active psoriasis or other dermatological conditions at affected area\n* Unable to gain consent from patient or patient's NOK"}, 'identificationModule': {'nctId': 'NCT03906032', 'briefTitle': 'Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Waterford'}, 'officialTitle': 'Prospective Randomized Controlled Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture', 'orgStudyIdInfo': {'id': 'UHWHip#'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intra-medullary hip Nail', 'description': 'Surgery', 'interventionNames': ['Device: TFNA IM Nail']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sliding hip screw', 'description': 'Surgery', 'interventionNames': ['Device: Sliding hip screw']}], 'interventions': [{'name': 'TFNA IM Nail', 'type': 'DEVICE', 'description': 'IM nail', 'armGroupLabels': ['Intra-medullary hip Nail']}, {'name': 'Sliding hip screw', 'type': 'DEVICE', 'description': 'SHS surgical fixation', 'armGroupLabels': ['Sliding hip screw']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Waterford', 'country': 'Ireland', 'facility': 'University Hospital Waterford', 'geoPoint': {'lat': 52.25833, 'lon': -7.11194}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Waterford', 'class': 'OTHER'}, 'collaborators': [{'name': 'DePuy Synthes', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'May Cleary', 'investigatorAffiliation': 'University Hospital Waterford'}}}}