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Computer-Assisted Fixation of Trochanteric Femur Fractures

Primary Purpose

Hip Fractures

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stryker© ADAPT™ platform
Traditional fluoroscopy
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Peritrochanteric femur fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Irving Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional fluoroscopy

Stryker© ADAPT™ platform

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Tip-apex distance (TAD)
Tip-apex distance of the lag screw in the femoral head as measured on postoperative anteroposterior and lateral x-rays

Secondary Outcome Measures

Lag screw position
Lag screw position in the femoral head/neck as described by Cleveland et al. (1959)
Operative time
The amount of time required to complete the surgical procedure
Fluoroscopy time
The amount of fluoroscopy utilized during the surgical procedure as measured in seconds
K-wire passes
The total number of K-wire passes prior to final lag screw placement
Evidence of lag screw cut-out
Evidence of lag screw cut-out as seen on postoperative hip radiographs
Hip range of motion
Postoperative range of motion of the affected hip as measured on physical examination
Patient mobility and social dependency
Postoperative patient mobility and social dependency as defined by the Harris Hip Score
Pain level
Postoperative pain level as defined by the visual analog scale

Full Information

First Posted
August 24, 2020
Last Updated
March 16, 2022
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT04528459
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 9, 2023 (Anticipated)
Study Completion Date
January 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Peritrochanteric femur fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Patients will be blinded to treatment group allocation, as will outcomes assessors. Clinicians performing the procedures will not be blinded.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional fluoroscopy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Stryker© ADAPT™ platform
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Stryker© ADAPT™ platform
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Traditional fluoroscopy
Intervention Description
For patients in the control group, traditional fluoroscopy will be utilized for placement of the cephalomedullary nail.
Primary Outcome Measure Information:
Title
Tip-apex distance (TAD)
Description
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
Secondary Outcome Measure Information:
Title
Lag screw position
Description
Lag screw position in the femoral head/neck as described by Cleveland et al. (1959)
Time Frame
Immediate postoperative period
Title
Operative time
Description
The amount of time required to complete the surgical procedure
Time Frame
Intraoperative period
Title
Fluoroscopy time
Description
The amount of fluoroscopy utilized during the surgical procedure as measured in seconds
Time Frame
Intraoperative period
Title
K-wire passes
Description
The total number of K-wire passes prior to final lag screw placement
Time Frame
Intraoperative period
Title
Evidence of lag screw cut-out
Description
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
Title
Hip range of motion
Description
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
Title
Patient mobility and social dependency
Description
Postoperative patient mobility and social dependency as defined by the Harris Hip Score
Time Frame
3 months, 6 months, 1 year, and 2 years after surgery
Title
Pain level
Description
Postoperative pain level as defined by the visual analog scale
Time Frame
3 months, 6 months, 1 year, and 2 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew J Anderson, MD
Phone
212-305-5974
Email
mja2206@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqueline Lenahan, BS
Phone
212-305-8193
Email
jl5092@cumc.columbia.edu
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wakenda K Tyler, MD
Phone
212-305-9192
Email
wkt2106@cumc.columbia.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
13849408
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.
Results Reference
result
PubMed Identifier
30782395
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.
Results Reference
result

Learn more about this trial

Computer-Assisted Fixation of Trochanteric Femur Fractures

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