Computer-Assisted Fixation of Trochanteric Femur Fractures

Columbia University

Status: Terminated

Conditions: Hip Fractures

Treatments: Radiation: Traditional fluoroscopy; Device: Stryker© ADAPT™ platform

Study type: Interventional

Funder types: Other

Identifiers

NCT04528459

AAAS7055

Details and patient eligibility

About

The purpose of this study is to assess whether the Stryker© ADAPT™ augmented-reality platform can assist surgeons in optimizing placement of the lag screw component of the Stryker© Gamma™ cephalomedullary nail.

Full description

This will be a prospective, randomized, single-blinded, controlled trial with two treatment cohorts. Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw. Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw. Patients will be blinded to treatment group allocation as will clinicians/researchers during data processing and analysis.

The primary outcome will be tip-apex distance, as measured on anteroposterior and lateral hip radiographs. Secondary outcomes will be position of the lag screw as described by Cleveland et al, operative time, fluoroscopy time, and number of Kirschner wire passes prior to final placement of the lag screw. Additionally, evidence of lag screw cutout on hip radiographs, hip range of motion relative to the contralateral hip, overall mobility, social dependency, and pain level will be assessed at 3 month, 6 month, 1 year, and 2 year follow up visits.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 18 years and older with isolated closed peritrochanteric femur fractures who are candidates for surgical fixation with a cephalomedullary nail device

Exclusion criteria

1. Patients with open peritrochanteric femur fractures or multiple injuries (i.e., polytrauma)
2. Patients with peritrochanteric femur fractures better treated with a device other than a cephalomedullary nail, as determined by the attending orthopedic surgeon
3. Patients less than 18 years of age

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups

Traditional fluoroscopy

Active Comparator group

Description:

Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).

Treatment:

Radiation: Traditional fluoroscopy

Stryker© ADAPT™ platform

Experimental group

Description:

Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™platform to assist with insertion of the lag screw.

Treatment:

Device: Stryker© ADAPT™ platform