Trigen InterTAN vs Sliding Hip Screw RCT

NCT03065101 | Terminated

• 1 other identifier: 15-3031-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 5

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.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Functional Independence Measure

  12 weeks, 6 months and 12 months post-surgery

• Get Up and Go Test

  Discharge (estimated 2 weeks post-surgery) and 6 months post-surgery

• Residential Status Questionnaire

  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-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)

  Pre-Op (Day prior to or day of surgery), immediately post-op and 6 months post-surgery

Study Arms (2)

Trigen Intertan

OTHER

* 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

Device: Trigen Intertan; Other: 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

Other: Post-Surgery Follow Up; Device: Sliding Hip Screw

Interventions

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.

Trigen Intertan

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; Trigen Intertan

Sliding Hip Screw DEVICE

Sliding Hip Screw

Sliding Hip Screw

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Sites (5)

Royal Devon and Exeter Hospital

Exeter, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

Derriford Hospital

Plymouth, United Kingdom

Location

Royal Cornwall Hospital

Truro, United Kingdom

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Stephen Mitchell, MBChB FRCS

  University Hospitals Bristol and Weston NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: February 27, 2017
• Study Start: September 30, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: March 29, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)