Introduction of the ADAPT System in an Orthopedic Department

Pertrochanteric Fracture Clinical Trial

— ADAPTintro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072847
• Other study ID #: ADAPT_1
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2023
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 1, 2023
• Est. primary completion date: January 31, 2023
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Fractures, Bone
• Pertrochanteric Fracture

Locations

Country	Name	City	State
Denmark	Orthopedic Department, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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