Computer-Assisted Fixation of Trochanteric Femur Fractures

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04528459
• Other study ID #: AAAS7055
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Columbia University
• Contact: Matthew J Anderson, MD
• Phone: 212-305-5974
• Email: mja2206[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Hip Fractures

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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 — View Citation

Outcome

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