NCT03875443

Brief 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. A historic cohort of patients operated at the University Hospital Basel for an intertrochanteric fracture from 2014-2015 will be used for comparison.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

January 8, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

March 13, 2019

Last Update Submit

January 17, 2022

Conditions

Hip Fractures

Keywords

implant positioningreductionintraoperative fluoroscopyreduction algorithm

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    6 months after hip surgery

Secondary Outcomes (5)

  • Hip re-operations

    6 months after hip surgery

  • Mortality

    6 months after hip surgery

  • Operation time from incision until closure of the wound (minutes)

    second postoperative day

  • Central placement of the femoral neck screw (degree)

    second postoperative day

  • Reduction of the calcar segment in the lateral view (mm)

    second postoperative day

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting with an intertrochanteric fracture or subtrochanteric fracture at the Department of Orthopaedic and Traumatology, University Hospital Basel

You may qualify if:

  • 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

You may not qualify if:

  • Patients operated without adherence to the reduction algorithm
  • Patients operated by surgeons who did not attend the teaching session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Henrik Eckardt, PD Dr. med

    Department of Orthopaedics and Traumatology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 14, 2019

Study Start

January 8, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 19, 2022

Record last verified: 2022-01

Locations

CH(1)