Computer-Assisted Fixation of Trochanteric Femur Fractures

NCT04528459 | Terminated Results FDA Device

• 1 other identifier: AAAS7055
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures

Keywords

Peritrochanteric femur fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Lag Screw Position

  Immediate postoperative period

• Operative Time

  Intraoperative period

• Fluoroscopy Time

  Intraoperative period

• K-wire Passes

  Intraoperative period

• Evidence of Lag Screw Cut-out

  3 months, 6 months, 1 year, and 2 years after surgery

Study Arms (2)

Traditional fluoroscopy

ACTIVE COMPARATOR

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

Stryker© ADAPT™ platform

EXPERIMENTAL

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

Interventions

Stryker© ADAPT™ platform DEVICE

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.

Stryker© ADAPT™ platform

Traditional fluoroscopy RADIATION

For patients in the control group, traditional fluoroscopy will be utilized for placement of the cephalomedullary nail.

Traditional fluoroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients aged 18 years and older with isolated closed peritrochanteric femur fractures who are candidates for surgical fixation with a cephalomedullary nail device

You may not qualify if:

• Patients with open peritrochanteric femur fractures or multiple injuries (i.e., polytrauma)
• Patients with peritrochanteric femur fractures better treated with a device other than a cephalomedullary nail, as determined by the attending orthopedic surgeon
• Patients less than 18 years of age

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related 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.

  PMID: 13849408 RESULT

• 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.

  PMID: 30782395 RESULT

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Results Point of Contact

• Title: Wakenda K. Tyler, MD, MPH
• Organization: Columbia University

wkt2106@cumc.columbia.edu

2123059192

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be blinded to treatment group allocation, as will outcomes assessors. Clinicians performing the procedures will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopedic Surgery

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 27, 2020
• Study Start: January 1, 2021
• Primary Completion: June 18, 2021
• Study Completion: June 18, 2021
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)