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Completed

NCT Number: NCT03875443

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

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.

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Key information

Conditions

Hip Fractures Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Instructional video

Other

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

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Hip re-operations

    Time frame: 6 months after hip surgery

    Number of re-operations due to loss of reduction

  2. Mortality

    Time frame: 6 months after hip surgery

    Number of patients that have died

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

    Time frame: second postoperative day

    Operation time from incision until closure of the wound

  4. Central placement of the femoral neck screw (degree)

    Time frame: second postoperative day

    Radiologic result: Central placement of the femoral neck screw as measured with the Tip-Apex-Distance

  5. Reduction of the calcar segment in the lateral view (mm)

    Time frame: second postoperative day

    Radiologic result: Reduction of the calcar segment in the lateral view

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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.

Acronym: PERTROCH

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 14, 2019
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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