Trigen InterTAN vs Sliding Hip Screw RCT

NCT ID: NCT03065101

Last Updated: 2019-03-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2017-09-30

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.

Conditions

Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Trigen Intertan

• Unique integrated interlocking screw and trapezoidal nail shape
• Resistance to femoral head rotation and cut-out
• Active compression through linear motion without rotation
• Single subtrochanteric lag screw option for stable fractures below lesser trochanter
• Preloaded cannulated set screw converts construct to fixed angle device
• Small proximal diameter of the nail promotes preservation of the lateral wall of the greater trochanter and gluteus medius tendon
• Clothespin tip for stress modulation in femoral shaft
• Potential for improved patient mobility and recovery

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

Group Type: OTHER

Trigen Intertan

Intervention Type: 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.

Post-Surgery Follow Up

Intervention Type: 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

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

Group Type: OTHER

Post-Surgery Follow Up

Intervention Type: 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

Intervention Type: DEVICE

Sliding Hip Screw

Interventions

Trigen Intertan

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.

Intervention Type: DEVICE

Post-Surgery Follow Up

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.

Intervention Type: OTHER

Sliding Hip Screw

Sliding Hip Screw

Intervention Type: DEVICE

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew Orthopaedics AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Mitchell, MBChB FRCS

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Bristol and Weston NHS Foundation Trust

Locations

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

Royal Cornwall Hospital

Truro, , United Kingdom

Countries

United Kingdom

Other Identifiers

15-3031-01

Identifier Type: -

Identifier Source: org_study_id