Computer-Assisted Fixation of Trochanteric Femur Fractures

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures
• Intervention / Treatment: Radiation: Traditional fluoroscopy; Device: Stryker© ADAPT™ platform

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacqueline Lenahan, BS; Phone Number: 212-305-8193; Email: jl5092@cumc.columbia.edu
• Study Contact Backup: Name: Matthew J Anderson, MD; Phone Number: 212-305-5974; Email: mja2206@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Contact: Wakenda K Tyler, MD; Phone Number: 212-305-9192; Email: wkt2106@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Radiation: Traditional fluoroscopy; For patients in the control group, traditional fluoroscopy will be utilized for placement of the cephalomedullary nail.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lag screw position	Lag screw position in the femoral head/neck as described by Cleveland et al. (1959)	Immediate postoperative period
Operative time	The amount of time required to complete the surgical procedure	Intraoperative period
Fluoroscopy time	The amount of fluoroscopy utilized during the surgical procedure as measured in seconds	Intraoperative period
K-wire passes	The total number of K-wire passes prior to final lag screw placement	Intraoperative period
Evidence of lag screw cut-out	Evidence of lag screw cut-out as seen on postoperative hip radiographs	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	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	3 months, 6 months, 1 year, and 2 years after surgery
Pain level	Postoperative pain level as defined by the visual analog scale	3 months, 6 months, 1 year, and 2 years after surgery

Collaborators and Investigators

• Sponsor: Columbia University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Peritrochanteric femur fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hip Injuries; Femoral Fractures; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: AAAS7055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No