Pertrochanteric FractureADAPTintroNCT05072847
Introduction of the ADAPT System in an Orthopedic Department
An observational study of Pertrochanteric Fracture, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pertrochanteric Fracture
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Surgeons who operated patients with pertrochanteric fractures with the use of a gamma3 nail
Who may be able to join
- Surgeons who operated patients with pertrochanteric fractures with the use of a gamma3 nail
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pertrochanteric Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ADAPT | The ADAPT system by Striker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Questionaire including the "system usability scale" will be send to surgeons within 24 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start1 Mar 2021
- Primary completion31 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertrochanteric FractureStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Gundtoft, Aarhus University Hospital
- Investigators
- per h gundtoft, md, Principal investigator, Aarhus University Hospital, orthopedic department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072847
- Sponsor's protocol ID
- ADAPT_1
- Acronym
- ADAPTintro
- Status last verified
- Feb 2023
- First submitted
- 29 Sep 2021
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of the ADAPT System for Pertrochanteric Fractures in an Orthopedic Department
- ClinicalTrials.gov ID
- NCT05072847
- Acronym / sponsor ID
- ADAPTintro / ADAPT_1
- Conditions
- Pertrochanteric Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADAPT | – | –The ADAPT system by Striker |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Surgeons who operated patients with pertrochanteric fractures with the use of a gamma3 nail
Key inclusion criteria (1 listed)
- Surgeons who operated patients with pertrochanteric fractures with the use of a gamma3 nail
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
System Usability Scale
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No. We do not plan to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
per h gundtoft, md principal investigator
Aarhus University Hospital, orthopedic department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertrochanteric Fracture, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: Questionaire including the "system usability scale" will be send to surgeons within 24 hours following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.