Trochanteric Fractures - How to Improve the Results of Reduction and Implant Positioning

Hip Fractures Clinical Trial

— PERTROCH  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03875443
• Other study ID #: 2019-00025; ch19Eckardt
• Status: Completed
• Start date: January 8, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Other:
• Instructional video
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 algorithm
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.

Locations

Country	Name	City	State
Switzerland	Department of Orthopaedics and Traumatology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Hip re-operations	Number of re-operations due to loss of reduction	6 months after hip surgery
Secondary	Mortality	Number of patients that have died	6 months after hip surgery
Secondary	Operation time from incision until closure of the wound (minutes)	Operation time from incision until closure of the wound	second postoperative day
Secondary	Central placement of the femoral neck screw (degree)	Radiologic result: Central placement of the femoral neck screw as measured with the Tip-Apex-Distance	second postoperative day
Secondary	Reduction of the calcar segment in the lateral view (mm)	Radiologic result: Reduction of the calcar segment in the lateral view	second postoperative day