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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00626470
First received: February 15, 2008
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Femoral Fractures
Procedure: Addition of TSP to DHS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomised Study of Unstable Trochanteric Femur Fractures Treated With Dynamic Hip Screw With and Without a Trochanter Support Plate

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • Fracture movement postoperatively [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reoperation [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Pain postoperatively [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Hip function postoperatively [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Fracture healing [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • complications postoperatively [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: -TSP
Patients operated without TSP
Procedure: Addition of TSP to DHS
All patients operated with DHS. Of these two groups. One operated with TSP and one without.
Active Comparator: +TSP
Patients operated with TSP
Procedure: Addition of TSP to DHS
All patients operated with DHS. Of these two groups. One operated with TSP and one without.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626470

Locations
Norway
Ortopaedic Department, St.Olavs Hospital
Trondheim, Norway, 7000
Sponsors and Collaborators
St. Olavs Hospital
Investigators
Principal Investigator: James Haddon, MD St. Olavs Hospital
  More Information

Publications:
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00626470     History of Changes
Other Study ID Numbers: TSP Study
Study First Received: February 15, 2008
Last Updated: August 18, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by St. Olavs Hospital:
Trochanter
Femur
Fracture

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014