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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
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.
For patients in the control group, traditional fluoroscopy will be utilized for placement of the cephalomedullary nail.
Columbia University Irving Medical Center
New York, New York, United States
Tip-apex Distance (TAD)
Tip-apex distance of the lag screw in the femoral head as measured on postoperative anteroposterior and lateral x-rays
Time frame: Immediate post-operative period
Lag Screw Position
Lag screw position in the femoral head/neck as described by Cleveland et al. (1959)
Time frame: Immediate postoperative period
Operative Time
The amount of time required to complete the surgical procedure
Time frame: Intraoperative period
Fluoroscopy Time
The amount of fluoroscopy utilized during the surgical procedure as measured in seconds
Time frame: Intraoperative period
K-wire Passes
The total number of K-wire passes prior to final lag screw placement
Time frame: Intraoperative period
Evidence of Lag Screw Cut-out
Evidence of lag screw cut-out as seen on postoperative hip radiographs
Time frame: 3 months, 6 months, 1 year, and 2 years after surgery
Hip Range of Motion
Postoperative range of motion of the affected hip as measured on physical examination
Time frame: 3 months, 6 months, 1 year, and 2 years after surgery
Patient Mobility and Social Dependency
Postoperative patient mobility and social dependency as defined by the Harris Hip Score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3 months, 6 months, 1 year, and 2 years after surgery
Pain Level
Postoperative pain level as defined by the visual analog scale
Time frame: 3 months, 6 months, 1 year, and 2 years after surgery