Computer-Assisted Fixation of Trochanteric Femur Fractures

Not Applicable

Terminated

Interventions: Device: Stryker© ADAPT™ platform
Radiation: Traditional fluoroscopy

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Stryker© ADAPT™ platform	Stryker© ADAPT™ platform	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.
Traditional fluoroscopy	Traditional fluoroscopy	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).

Primary Outcome Measures

Name	Time	Method
Tip-apex Distance (TAD)	Immediate post-operative period	Tip-apex distance of the lag screw in the femoral head as measured on postoperative anteroposterior and lateral x-rays

Secondary Outcome Measures

Name	Time	Method
Lag Screw Position	Immediate postoperative period	Lag screw position in the femoral head/neck as described by Cleveland et al. (1959)
Operative Time	Intraoperative period	The amount of time required to complete the surgical procedure
Fluoroscopy Time	Intraoperative period	The amount of fluoroscopy utilized during the surgical procedure as measured in seconds
K-wire Passes	Intraoperative period	The total number of K-wire passes prior to final lag screw placement
Evidence of Lag Screw Cut-out	3 months, 6 months, 1 year, and 2 years after surgery	Evidence of lag screw cut-out as seen on postoperative hip radiographs
Hip Range of Motion	3 months, 6 months, 1 year, and 2 years after surgery	Postoperative range of motion of the affected hip as measured on physical examination
Patient Mobility and Social Dependency	3 months, 6 months, 1 year, and 2 years after surgery	Postoperative patient mobility and social dependency as defined by the Harris Hip Score
Pain Level	3 months, 6 months, 1 year, and 2 years after surgery	Postoperative pain level as defined by the visual analog scale