Intertrochanteric Femoral Fracture Fixation Trial

NCT02627040 | Unknown

• 1 other identifier: 00023144
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

Brief Summary

The main goal of the study is to determine which cephalomedullary nail results in a better functional outcome for the patient with an unstable intertrochanteric hip fracture. Subjects will be randomized to fixation with either a Gamma3 cephalomedullary nail or an InterTan cephalomedullary nail. Outcomes will be reviewed over a 12 month follow-up period.

Conditions

Intertrochanteric Fracture; Hip Fracture

Outcome Measures

Primary Outcomes (1)

• Hip Function

  Hip Function measured with Harris Hip Score.

  6 months post-operatively

Secondary Outcomes (4)

• Functional outcome

  6 months post-operatively

• Walking ability

  3 months post-operatively

• Hip range of motion

  6 months post-operatively

• Hip Pain

  6 months post-operatively

Study Arms (2)

InterTan Intertrochanteric Nail

ACTIVE COMPARATOR

'Surgical fixation' of intertrochanteric fracture with a cephalomedullary nail with an InterTan device (two-integrated screws)

Device: InterTan Intertrochanteric Nail

Gamma 3 Intertrochanteric Nail

ACTIVE COMPARATOR

'Surgical fixation' of intertrochanteric fracture with a cephalomedullary nail and Gamma 3 locking nail (single screw)

Device: Gamma 3 Intertrochanteric Nail

Interventions

InterTan Intertrochanteric Nail DEVICE

Cephalomedullary fixation of intertrochanteric fracture with an InterTan Intertrochanteric Nail

InterTan Intertrochanteric Nail

Gamma 3 Intertrochanteric Nail DEVICE

Cephalomedullary fixation of intertrochanteric fracture with an Gamma 3 Intertrochanteric Nail

Gamma 3 Intertrochanteric Nail

Eligibility Criteria

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

You may qualify if:

• Patients surgically treated for an intertrochanteric femur fracture at Tampa General Hospital.
• Skeletally mature patients over the age of 60; both genders.
• Community ambulators.

You may not qualify if:

• Patients with ipsilateral lower extremity injury
• Patients under age 60
• Co-existent, severe knee or back problems
• Muscle contracture around the knee or hip joint
• Individuals who have had TKA within 6 months
• Body mass index (BMI; kg/m2) \>40
• Suspicious of pathologic fracture (tumor in origin)
• Pre-op mobility: Non ambulatory; ambulatory indoors with living support
• Cognitive impairment or dementia
• Prisoners or impending incarceration
• Homeless or no stable address.

Sponsors & Collaborators

• Florida Orthopaedic Institute: lead

Study Sites (2)

Brandon Regional Hospital

Brandon, Florida, 33511, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Hassan R Mir, MD, MBA

  Florida Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 10, 2015
• Study Start: November 30, 2015
• Primary Completion: August 31, 2020
• Study Completion: September 1, 2020
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)