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Completed

NCT Number: NCT00626470

Prospective Trial on Trochanteric Femur Fractures Treated With or Without a Trochanter Support Plate

Fractures just below the hip often are treated with a so called Gliding Screw and Plate (DHS). Recently a new additional plate called a Trochanter Support Plate (TSP) which attaches to the DHS has become available which is claimed to give extra support to the fracture. In a prospective randomised study we wish to test the hypothesis that the TSP does not give any additional stability to the fracture treated with the DHS.

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Key information

Conditions

Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ortopaedic Department, St.Olavs Hospital

Trondheim, 7000, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of unstable trochanteric femur fracture.(Evans-Jensen class.3-5)
  • (can include; Patients with cognitive problems (ie. dementia etc)

Exclusion criteria

  • Patients with pathological fractures
  • Multitrauma patients
  • Patients not able to walk before the fracture
  • Under 19 years old.
  • Patients with fractures needing other treatments than gliding hip screws
  • Reverse oblique fractures.

Treatment and study plan

Addition of TSP to DHS

Procedure

All patients operated with DHS. Of these two groups. One operated with TSP and one without.

Primary outcomes

  1. Fracture movement postoperatively

    Time frame: One year

Secondary outcomes

  1. Reoperation

    Time frame: One year

  2. Pain postoperatively

    Time frame: one year

  3. Hip function postoperatively

    Time frame: one year

  4. Fracture healing

    Time frame: one year

  5. complications postoperatively

    Time frame: one year

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Registry information

Official study title

A Prospective Randomised Study of Unstable Trochanteric Femur Fractures Treated With Dynamic Hip Screw With and Without a Trochanter Support Plate

Acronym: TSP

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Feb 29, 2008
Registry last updated
Oct 2, 2017

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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