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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04528459
Other study ID # AAAS7055
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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