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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures
• Intervention / Treatment: Other: Instructional video; Other: Reduction algorithm

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 Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Orthopaedics and Traumatology, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip re-operations	Number of re-operations due to loss of reduction	6 months after hip surgery
Mortality	Number of patients that have died	6 months after hip surgery
Operation time from incision until closure of the wound (minutes)	Operation time from incision until closure of the wound	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	second postoperative day
Reduction of the calcar segment in the lateral view (mm)	Radiologic result: Reduction of the calcar segment in the lateral view	second postoperative day

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Henrik Eckardt, PD Dr. med, Department of Orthopaedics and Traumatology, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 8, 2020
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (ACTUAL): March 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: reduction; intraoperative fluoroscopy; implant positioning; reduction algorithm
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 2019-00025; ch19Eckardt

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No