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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00626470
Acronym
TSP
Enrollment
100
Registered
2008-02-29
Start date
2008-12-31
Completion date
2014-12-31
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Fractures

Keywords

Trochanter, Femur, Fracture

Brief summary

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.

Interventions

PROCEDUREAddition of TSP to DHS

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

Sponsors

St. Olavs Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Fracture movement postoperativelyOne year

Secondary

MeasureTime frame
ReoperationOne year
Pain postoperativelyone year
Hip function postoperativelyone year
Fracture healingone year
complications postoperativelyone year

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026