Clinical trial NCT04528459: Computer-Assisted Fixation of Trochanteric Femur Fractures
Official title: Computer-Assisted Surgery for Internal Fixation of Peritrochanteric Femur Fractures: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hip Fractures
Keywords: Peritrochanteric femur fractures
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be divided into two treatment arms: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tip-apex Distance (TAD)
timeFrame: Immediate post-operative period
Secondary outcomes:
measure: Lag Screw Position
timeFrame: Immediate postoperative period
measure: Operative Time
timeFrame: Intraoperative period
measure: Fluoroscopy Time
timeFrame: Intraoperative period
measure: K-wire Passes
timeFrame: Intraoperative period
measure: Evidence of Lag Screw Cut-out
timeFrame: 3 months, 6 months, 1 year, and 2 years after surgery
measure: Hip Range of Motion
timeFrame: 3 months, 6 months, 1 year, and 2 years after surgery
measure: Patient Mobility and Social Dependency
timeFrame: 3 months, 6 months, 1 year, and 2 years after surgery
measure: Pain Level
timeFrame: 3 months, 6 months, 1 year, and 2 years after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
References:
citation: CLEVELAND M, BOSWORTH DM, THOMPSON FR, WILSON HJ Jr, ISHIZUKA T. A ten-year analysis of intertrochanteric fractures of the femur. J Bone Joint Surg Am. 1959 Dec;41-A:1399-408. No abstract available.
citation: Herzog J, Wendlandt R, Hillbricht S, Burgkart R, Schulz AP. Optimising the tip-apex-distance in trochanteric femoral fracture fixation using the ADAPT-navigated technique, a longitudinal matched cohort study. Injury. 2019 Mar;50(3):744-751. doi: 10.1016/j.injury.2019.02.010. Epub 2019 Feb 13.