Clinical trial NCT03875443: Trochanteric Fractures - How to Improve the Results of Reduction and Implant Positioning
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Keywords: implant positioning
reduction
intraoperative fluoroscopy
reduction algorithm
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting with an intertrochanteric fracture or subtrochanteric fracture at the Department of Orthopaedic and Traumatology, University Hospital Basel

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Shortening of the femoral neck (mm)
timeFrame: 6 months after hip surgery
measure: Change of the shaft-neck angle (degree)
timeFrame: 6 months after hip surgery
measure: Displacement of the calcar segment in the lateral view
timeFrame: 6 months after hip surgery
measure: Central placement of the femoral neck screw (degree)
timeFrame: 6 months after hip surgery
Secondary outcomes:
measure: Hip re-operations
timeFrame: 6 months after hip surgery
measure: Mortality
timeFrame: 6 months after hip surgery
measure: Operation time from incision until closure of the wound (minutes)
timeFrame: second postoperative day
measure: Central placement of the femoral neck screw (degree)
timeFrame: second postoperative day
measure: Reduction of the calcar segment in the lateral view (mm)
timeFrame: second postoperative day
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Traumatology, University Hospital Basel
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
name: Henrik Eckardt, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References: