ADAPTintro: Introduction of the ADAPT System in an Orthopedic Department

Sponsor

Aarhus University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05072847

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
ADAPT The ADAPT system by Striker

Outcome Measures

Primary Outcome Measures

System Usability Scale [Questionaire including the "system usability scale" will be send to surgeons within 24 hours following surgery]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orthopedic Department, Aarhus University Hospital	Aarhus		Denmark	8200

Sponsors and Collaborators

Aarhus University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Per Gundtoft, Principal Investigator, Consultant, PhD, Aarhus University Hospital

ClinicalTrials.gov Identifier:

NCT05072847

Other Study ID Numbers:

ADAPT_1

First Posted:

Oct 11, 2021

Last Update Posted:

Nov 5, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fractures, Bone

Study Results

No Results Posted as of Nov 5, 2021