NCT04528459

Computer-Assisted Fixation of Trochanteric Femur Fractures

Computer-Assisted Surgery for Internal Fixation of Peritrochanteric Femur Fractures: A Randomized Controlled Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Fractures

Interventions

Type	Name	Description
DEVICE	Stryker© ADAPT™ platform	The ADAPT system is a software platform that utilizes augmented reality to assist surgeons with implant alignment, lag screw length and positioning, and distal interlocking screw placement for cephalomedullary fixation of peritrochanteric femur fractures.
RADIATION	Traditional fluoroscopy	For patients in the control group, traditional fluoroscopy will be utilized for placement of the cephalomedullary nail.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-06-18
• Completion: 2021-06-18
• First posted: 2020-08-27
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study