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The purpose of this study is to compare the Trigen InterTAN Intramedullary nail to Sliding Hip Screws in AO/OTA 31-A1 and A2 intertrochanteric hip fractures.
A multicentre, randomised controlled trial, conducted in the UK will recruit 180 subjects, randomised to receive either the Trigen InterTAN Nail or the Sliding Hip Screw.
Subjects presenting at participating hospitals with AO/OTA 31-A1 or A2 fractures will be assessed against the eligibility criteria and approached for Informed Consent.
Subjects who are considered eligible and who have provided Informed Consent will be randomised using iDataFax to one of the two treatment options.
Subjects will be operated on according to standard procedure and the Instructions for Use.
A daily inpatient assessment will record the subjects use of opioid pain medication.
Subjects will be assessed at the time of discharge to record their residential and ambulatory status, Functional Independence Measure, Get Up and Go Test and opioid usage.
At 8 weeks and 12 weeks post surgery, subjects will be contacted by telephone to confirm their residential and ambulatory status, Functional Independence Measure, modified Harris Hip Score and Euroqol-5D.
At 6 months post surgery, subjects will attend an outpatient visit to have a follow up radiograph, Get Up and Go Test, residential and ambulatory status, Functional Independence Measure, modified Harris Hip Score and Euroqol-5D.
At 12 months post surgery, subjects will be contacted by telephone to confirm their residential and ambulatory status, Functional Independence Measure, modified Harris Hip Score and Euroqol-5D.
Adverse events, device deficiencies and reoperations will be recorded as and when they occur throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trigen Intertan | Other |
Manufactured by Smith & Nephew Inc., 1450 Brooks Road, Memphis, TN 38116, U.S.A. Interventions: Randomisation to either Trigen Intertan or Sliding Hip Screw, Post-Surgery Follow Up |
|
| Sliding Hip Screw | Other | SHS is a generic term for a group of devices used for internal fixation of trochanteric hip fractures. Also known as Compression Hip Screw or Dynamic Hip Screw. All devices feature a lag screw inserted into the femoral neck and a side plate held in place by cortical screws inserted into the proximal femoral shaft. Therapeutic effect is achieved by guided collapse, where the lag screw can slide in the barrel of the side plate which compresses the fracture as the patient begins to weight-bear. Participating sites may use whichever brand of SHS is currently in use. Interventions: Randomisation to either Trigen Intertan or Sliding Hip Screw, Post-Surgery Follow Up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trigen Intertan | Device | While both the Trigen InterTAN and Sliding Hip Screw are marketed and demonstrated to be suitable for treatment of the study indication, the randomisation is considered an intervention as it may be contrary to the treatment chosen by the surgeon were the patient not a study subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measure (motor portion) | The FIM instrument is a basic indicator of severity of disability. Comprises 18 items assessed against a seven point ordinal scale, where the higher the score for an item, the more independently the patient is able to perform the tasks assessed by that item. Total scores range from 18 to 126. The items are divided into 13 Motor items and 5 Cognitive Items. The rating scale designates major graduations in behaviour from dependence to independence. The scale provides for the classification of individuals by their ability to carry out an activity independently, versus their need for assistance from another person or a device. If help is needed the scale assesses the degree of that need. Patient reported outcome. | 8 weeks post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measure | The FIM instrument is a basic indicator of severity of disability. Comprises 18 items assessed against a seven point ordinal scale, where the higher the score for an item, the more independently the patient is able to perform the tasks assessed by that item. Total scores range from 18 to 126. The items are divided into 13 Motor items and 5 Cognitive Items. The rating scale designates major graduations in behaviour from dependence to independence. The scale provides for the classification of individuals by their ability to carry out an activity independently, versus their need for assistance from another person or a device. If help is needed the scale assesses the degree of that need. Patient reported outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Mitchell, MBChB FRCS | University Hospitals Bristol and Weston NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Devon and Exeter Hospital | Exeter | United Kingdom | ||||
| Gloucestershire Royal Hospital |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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|
| Post-Surgery Follow Up | Other | The current clinical trend is for minimal follow up post-surgery, unless indicated by complications. The study protocol indicated that follow up telephone visits are to be performed at 8 weeks, 12 weeks and 12 months post-surgery and an outpatient follow up visit at 6 months post-surgery. While most outcome measures are conducted via questionnaire, the increase in follow up means that subjects may be exposed to increased ionising radiation. |
|
| Sliding Hip Screw | Device | Sliding Hip Screw |
|
| 12 weeks, 6 months and 12 months post-surgery |
| Get Up and Go Test | Requires the study subject to;
1. Normal 2. Very slightly abnormal 3. Mildly abnormal 4. Moderately abnormal 5. Severely abnormal Subjects will be scored as above and whether any mobility aids were required. The GUG Test will be supervised and recorded by study staff. | Discharge (estimated 2 weeks post-surgery) and 6 months post-surgery |
| Residential Status Questionnaire | Pre-operatively it will be recorded what the subjects' residential status was prior to injury, whether they were;
| Pre-Op (Day prior to or day of surgery), Discharge (estimated 2 weeks post-surgery), 8 weeks, 12 weeks, 6 months and 12 months post-surgery |
| Ambulatory Status Questionnaire | Pre-operatively it will be recorded what the subjects' ambulatory status was prior to injury inside and outside their living environment, whether they were;
| Pre-Op (Day prior to or day of surgery), Discharge (estimated 2 weeks post-surgery), 8 weeks, 12 weeks, 6 months and 12 months post-surgery |
| Radiographic Assessment (calculation of medialisation, shortening and tip-apex distance) | A pre-operative low centred anteroposterior (AP) pelvis and lateral hip X-ray radiograph will be taken for diagnostic purposes. If a deformity is noted, a full length AP and lateral femur X-ray will be conducted in addition. The post-operative low centre AP pelvis and lateral hip X-ray radiographic assessment will record;
| Pre-Op (Day prior to or day of surgery), immediately post-op and 6 months post-surgery |
| Modified Harris Hip Score | The HHS was developed to assess the results of hip surgery, first described in 1969 . A modified version (mHHS) is used in this study which records the subjects' experience of pain (worth a maximum of 44 points) and activities of daily living and gait (worth a maximum of 47 points). A higher score is associated with a better outcome. Questions include pain experienced, the distance the subject can walk, ability to put on socks and shoes, ability to use public transportation, supports needed, limp, ability to use stairs and any problems in sitting. Deformity and range of motion measurements are excluded from the standard HHS in order to allow remote completion. This assessment is recorded by a clinician onto the CRF via interview with the subject. | 8 weeks, 12 weeks, 6 months and 12 months post-surgery |
| EQ-5D | The EuroQol EQ-5D is a standardized instrument for use as a measurement of health outcome. It consists of a descriptive system with 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) which are each assigned three levels (no problems, some problems, extreme problems) and a Visual Analogue Scale where subjects indicate a numerical value from 0-100 where 0 is the worst imaginable health state and 100 is the best imaginable health state. The EQ-5D is a patient reported outcome. | 8 weeks, 12 weeks, 6 months and 12 months post-surgery |
| Log of opioid medication administered | A daily assessment of opioid usage will be made including recording; • For each adminstration;
| Daily from day 1 post-surgery to discharge (estimated 2 weeks post-surgery) |
| Gloucester |
| United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| Derriford Hospital | Plymouth | United Kingdom |
| Royal Cornwall Hospital | Truro | United Kingdom |
| D007869 |
| Leg Injuries |