Clinical trial NCT03065101: Trigen InterTAN vs Sliding Hip Screw RCT
Official title: Functional Advantages of TRIGEN™ INTERTAN™ Over Sliding Hip Screw in Subjects With Trochanteric Hip Fracture: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hip Fractures
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-27
Enrollment: 34
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Independence Measure (motor portion)
timeFrame: 8 weeks post-surgery
Secondary outcomes:
measure: Functional Independence Measure
timeFrame: 12 weeks, 6 months and 12 months post-surgery
measure: Get Up and Go Test
timeFrame: Discharge (estimated 2 weeks post-surgery) and 6 months post-surgery
measure: Residential Status Questionnaire
timeFrame: 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
measure: Ambulatory Status Questionnaire
timeFrame: 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
measure: Radiographic Assessment (calculation of medialisation, shortening and tip-apex distance)
timeFrame: Pre-Op (Day prior to or day of surgery), immediately post-op and 6 months post-surgery
measure: Modified Harris Hip Score
timeFrame: 8 weeks, 12 weeks, 6 months and 12 months post-surgery
measure: EQ-5D
timeFrame: 8 weeks, 12 weeks, 6 months and 12 months post-surgery
measure: Log of opioid medication administered
timeFrame: Daily from day 1 post-surgery to discharge (estimated 2 weeks post-surgery)
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
affiliation: University Hospitals Bristol and Weston NHS Foundation Trust
name: Stephen Mitchell, MBChB FRCS
role: PRINCIPAL_INVESTIGATOR
References: