Introduction of the ADAPT System in an Orthopedic Department (ADAPTintro)

Introduction of the ADAPT System for Pertrochanteric Fractures in an Orthopedic Department

The ADAPT system by Stryker is introduced in the orthopedic department (at Aarhus University Hospital). Following the introduction of the ADAPT system all pertrochanteric fractures operated with a gamma3 nail by stryker are operated with the use of the ADAPT system. Following surgery the operating surgeon fill out a questionaire on the use of ADAPT.

Study Overview

• Status: Completed
• Conditions: Pertrochanteric Fracture

Detailed Description

At the ortopedic department, Aarhus University Hospital pertrochanteric fractures are mostly operated with the gamma3 system by Stryker.

The ADAPT system is software based instrumentation designed for use in Gamma3 surgery. The software assists the surgeon with implant alignment, lag screw length determination, lag screw positioning and distal targeting. ADAPT is the only augmented reality instrumentation of its kind.

From March 1, 2021 it becomes mandatory for all orthopedic surgeons at the department to use the ADAPT system when operating pertrochanteric fractures with a gamma3 nail. Following surgery the operating surgeon will fill out the System Usability Scale questionaire and an additional 3 questions.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Orthopedic Department, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Surgeons who operated patients with pertrochanteric fractures with the use of a gamma3 nail

Description

Inclusion Criteria:

• Surgeons who operated patients with pertrochanteric fractures with the use of a gamma3 nail

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ADAPT; The ADAPT system by Striker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale	Result of the "System Usability Scale" questionaire. The "System Usability Scale" is a questionaire that include 10 questions that participans rank from 1 to 5 (5 means they agree completely, 1 that they disagreee). Highest score is 100 due to the calculation process. Above 80.3 means that the participans are finding ADAPT very usefull and will recommend the use of the system to collegeaus, Above 68 means that participans finds ADAPT usefull, Below 51 means participans finds ADAPT unusefull.	Questionaire including the "system usability scale" will be send to surgeons within 24 hours following surgery

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Investigators: Principal Investigator: per h gundtoft, md, Aarhus University Hospital, orthopedic department

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ACTUAL): January 31, 2023
• Study Completion (ACTUAL): February 1, 2023

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (ACTUAL): October 11, 2021

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: ADAPT_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No