Hip FracturesPERTROCHNCT03875443
Trochanteric Fractures - How to Improve the Results of Reduction and Implant Positioning
An observational study of Hip Fractures, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This prospective study (including patients with an intertrochanteric or subtrochanteric fractures type 31A1, 31A2 and 31A3) is to assess the effect of an educational intervention for operating surgeons with respect to an improvement of the quality of reduction and internal stabilisation of intertrochanteric fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Instructional video and Reduction algorithm
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Jan 2020to 31 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with an intertrochanteric fracture or subtrochanteric fracture at the Department of Orthopaedic and Traumatology, University Hospital Basel
Who may be able to join
- Patients presenting with an intertrochanteric fracture type 31A1 or 31A2 or subtrochanteric fracture type 31A3
- Surgeon must have completed the teaching video on how to evaluate intraoperatively the fracture, the reduction and the implant positioning and complete the reduction algorithm documenting that all intraoperative steps have been correctly accomplished
Who cannot join
- Patients operated without adherence to the reduction algorithm
- Patients operated by surgeons who did not attend the teaching session
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedics and Traumatology, University Hospital Basel
Basel, 4031
About this study
Official title: Structured Educational Program and the Use of a Practical Algorithm for Reduction and Stabilisation of Trochanteric Fractures With in Intramedullary Nail Improved Radiologic Reduction and Implant Positioning. A Prospective Study With 6 Months Follow-up.
This prospective study (including patients with an intertrochanteric or subtrochanteric fractures type 31A1, 31A2 and 31A3) is to assess the effect of an educational intervention for operating surgeons with respect to an improvement of the quality of reduction and internal stabilisation of intertrochanteric fractures. A historic cohort of patients operated at the University Hospital Basel for an intertrochanteric fracture from 2014-2015 will be used for comparison.
Read the detailed description
Intertrochanteric fractures are one of the most frequent fracture type in the elderly population usually occurring in patients older than 60 years of age. Almost all fractures are treated operatively with reduction and stabilisation of the fracture using either a dynamic hip screw or an intramedullary nail. The reduction of the fracture and positioning of the implant are surgeon dependent factors and can be influenced by educational interventions. The investigators hypothesized that a structured educational program on the optimal use of intraoperative fluoroscopy to control the quality of reduction and the position of the implant, as well as the provision of a practical algorithm intraoperatively guiding reduction and stabilisation of intertrochanteric fractures would improve the radiologic outcome.
- Conditions
- Hip Fractures
- Being tested
- Instructional video, Reduction algorithm
- Keywords
- implant positioning, reduction, intraoperative fluoroscopy, reduction algorithm
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instructional videoOther
Video (produced by AO Trauma and Prof. Daniel Rikli) includes a stepwise and structured explanation of the different fluoroscopic views necessary to evaluate intraoperatively with the fluoroscope different aspects of the proximal femur. The video is publically available under: (https://www.aointeract.org/#/watch/video/L3YxL3ZpZGVvcy8xOTc=/intraoperative-imaging-of-femur).
Reduction algorithmOther
Intraoperative reduction algorithm (developed by PD Henrik Eckardt); each step in the algorithm will be checked and documented with the fluoroscope and archived using the store function of the fluoroscope.
What is being measured
The primary outcome is the main question the study is designed to answer.
Shortening of the femoral neck (mm)
Radiologic result: Shortening of the femoral neck as measured with sliding of the femoral neck screw inside the nail
Measured: 6 months after hip surgery
Change of the shaft-neck angle (degree)
Radiologic result: Change of the shaft-neck angle on the antero-posterior view in comparison to postoperative value
Measured: 6 months after hip surgery
Displacement of the calcar segment in the lateral view
Radiologic result: Displacement of the calcar segment in the lateral view
Measured: 6 months after hip surgery
Central placement of the femoral neck screw (degree)
Radiologic result: Central placement of the femoral neck screw as measured with the Tip-Apex-Distance
Measured: 6 months after hip surgery
Secondary outcomes (5)
Hip re-operations
Number of re-operations due to loss of reduction
Measured: 6 months after hip surgery
Mortality
Number of patients that have died
Measured: 6 months after hip surgery
Operation time from incision until closure of the wound (minutes)
Operation time from incision until closure of the wound
Measured: second postoperative day
Central placement of the femoral neck screw (degree)
Radiologic result: Central placement of the femoral neck screw as measured with the Tip-Apex-Distance
Measured: second postoperative day
Reduction of the calcar segment in the lateral view (mm)
Radiologic result: Reduction of the calcar segment in the lateral view
Measured: second postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start8 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henrik Eckardt, PD Dr. med, Principal investigator, Department of Orthopaedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875443
- Sponsor's protocol ID
- 2019-00025; ch19Eckardt
- Other IDs
- 2019
- Acronym
- PERTROCH
- Status last verified
- Jan 2022
- First submitted
- 13 Mar 2019
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Educational Program and the Use of a Practical Algorithm for Reduction and Stabilisation of Trochanteric Fractures With in Intramedullary Nail Improved Radiologic Reduction and Implant Positioning. A Prospective Study With 6 Months Follow-up.
- ClinicalTrials.gov ID
- NCT03875443
- Acronym / sponsor ID
- PERTROCH / 2019-00025; ch19Eckardt
- Conditions
- Hip Fractures
- Keywords
- implant positioning, reduction, intraoperative fluoroscopy, reduction algorithm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Mar 2019 (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.
This prospective study (including patients with an intertrochanteric or subtrochanteric fractures type 31A1, 31A2 and 31A3) is to assess the effect of an educational intervention for operating surgeons with respect to an improvement of the quality of reduction and internal stabilisation of intertrochanteric fractures. A historic cohort of patients operated at the University Hospital Basel for an intertrochanteric fracture from 2014-2015 will be used for comparison.
Detailed description
Intertrochanteric fractures are one of the most frequent fracture type in the elderly population usually occurring in patients older than 60 years of age. Almost all fractures are treated operatively with reduction and stabilisation of the fracture using either a dynamic hip screw or an intramedullary nail. The reduction of the fracture and positioning of the implant are surgeon dependent factors and can be influenced by educational interventions. The investigators hypothesized that a structured educational program on the optimal use of intraoperative fluoroscopy to control the quality of reduction and the position of the implant, as well as the provision of a practical algorithm intraoperatively guiding reduction and stabilisation of intertrochanteric fractures would improve the radiologic outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with an intertrochanteric fracture or subtrochanteric fracture at the Department of Orthopaedic and Traumatology, University Hospital Basel
Key inclusion criteria (2 listed)
- Patients presenting with an intertrochanteric fracture type 31A1 or 31A2 or subtrochanteric fracture type 31A3
- Surgeon must have completed the teaching video on how to evaluate intraoperatively the fracture, the reduction and the implant positioning and complete the reduction algorithm documenting that all intraoperative steps have been correctly accomplished
Key exclusion criteria (2 listed)
- Patients operated without adherence to the reduction algorithm
- Patients operated by surgeons who did not attend the teaching session
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instructional videoVideo (produced by AO Trauma and Prof. Daniel Rikli) includes a stepwise and structured explanation of the different fluoroscopic views necessary to evaluate intraoperatively with the fluoroscope different aspects of the proximal femur. The video is publically available under: (https://www.aointeract.org/#/watch/video/L3YxL3ZpZGVvcy8xOTc=/intraoperative-imaging-of-femur). | Other | – |
| Reduction algorithmIntraoperative reduction algorithm (developed by PD Henrik Eckardt); each step in the algorithm will be checked and documented with the fluoroscope and archived using the store function of the fluoroscope. | Other | – |
Primary outcome
Shortening of the femoral neck (mm)
Time frame: 6 months after hip surgery
Radiologic result: Shortening of the femoral neck as measured with sliding of the femoral neck screw inside the nail
Change of the shaft-neck angle (degree)
Time frame: 6 months after hip surgery
Radiologic result: Change of the shaft-neck angle on the antero-posterior view in comparison to postoperative value
Displacement of the calcar segment in the lateral view
Time frame: 6 months after hip surgery
Radiologic result: Displacement of the calcar segment in the lateral view
Central placement of the femoral neck screw (degree)
Time frame: 6 months after hip surgery
Radiologic result: Central placement of the femoral neck screw as measured with the Tip-Apex-Distance
5 secondary outcomes
Hip re-operations
Time frame: 6 months after hip surgery
Mortality
Time frame: 6 months after hip surgery
Operation time from incision until closure of the wound (minutes)
Time frame: second postoperative day
Central placement of the femoral neck screw (degree)
Time frame: second postoperative day
Reduction of the calcar segment in the lateral view (mm)
Time frame: second postoperative day
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 19 Jan 2022.
Related trials for Hip Fractures
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
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.
Henrik Eckardt, PD Dr. med principal investigator
Department of Orthopaedics and Traumatology, University Hospital Basel
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 Hip Fractures, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 inclusion and 2 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 19 Jan 2022. 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 Switzerland. 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?
Shortening of the femoral neck (mm) (time frame: 6 months after hip surgery). The study lists 4 primary outcomes in all. 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 19 Jan 2022.