Trigen InterTAN vs Sliding Hip Screw RCT

Smith & Nephew Orthopaedics AG34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hip Fractures

Interventions

Trigen IntertanDEVICE

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.

Post-Surgery Follow UpOTHER

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 ScrewDEVICE

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * has closed trochanteric hip fracture (AO/OTA 31-A1 or A2) requiring treatment with internal fixation * has injury due to low energy trauma * is independently ambulatory in living environment prior to injury (walking aids permitted) * is \>60 years of age * is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires * has consented to participate in the study by signing the Ethics Committee (EC) approved ICF * has definitive fracture fixation \<72h from admission Exclusion Criteria: * has any additional injury or disability affecting mobility or affecting use of walking aids * has a pathological fracture (excluding osteoporotic fracture) * has an existing implant in study hip * has diagnosis of an immunosuppressive disorder * has an active infection, treated or untreated, systemic or at the site of the - has a condition that may interfere with the outcome of the study, including but not limited to: Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease * has a BMI \>40 * has an inadequate bone stock to support the device which would make the procedure unjustifiable, including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia * is pregnant or plans to become pregnant during the course of the study * is a prisoner or is facing impending incarceration * in the opinion of the PI, has an emotional or neurological condition that would interfere with their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse * is entered in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days * is known to be at risk for lost to follow-up, or failure to return for scheduled visits

Locations (5)

Royal Devon and Exeter Hospital

Exeter, United Kingdom

Gloucestershire Royal Hospital

Gloucester, United Kingdom

Royal Liverpool University Hospital

Liverpool, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks post-surgery

Secondary Outcomes

Functional Independence Measure

Time frame: 12 weeks, 6 months and 12 months post-surgery

Get Up and Go Test

Requires the study subject to; 1. Sit comfortably in a straight-backed chair 2. Rise from the chair 3. Stand still momentarily 4. Walk a short distance (approximately 3 metres) 5. Turn around 6. Walk back to the chair 7. Turn around 8. Sit down in the chair Movements are observed for any deviation from a confident, normal performance and recorded as; 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.

Data from ClinicalTrials.gov

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