NCT00626470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

5 years

First QC Date

February 15, 2008

Last Update Submit

September 28, 2017

Conditions

Femoral Fractures

Keywords

TrochanterFemurFracture

Outcome Measures

Primary Outcomes (1)

  • Fracture movement postoperatively

    One year

Secondary Outcomes (5)

  • Reoperation

    One year

  • Pain postoperatively

    one year

  • Hip function postoperatively

    one year

  • Fracture healing

    one year

  • complications postoperatively

    one year

Study Arms (2)

-TSP

ACTIVE COMPARATOR

Patients operated without TSP

Procedure: Addition of TSP to DHS

+TSP

ACTIVE COMPARATOR

Patients operated with TSP

Procedure: Addition of TSP to DHS

Interventions

Addition of TSP to DHSPROCEDURE

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

+TSP-TSP

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ortopaedic Department, St.Olavs Hospital

Trondheim, 7000, Norway

Location

MeSH Terms

Conditions

Femoral FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Wounds and InjuriesLeg Injuries

Study Officials

  • James Haddon, MD

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 29, 2008

Study Start

December 1, 2008

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

NO(1)