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

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ClinicalTrials.gov Identifier: NCT00626470
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital

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.

Condition or disease Intervention/treatment Phase
Femoral Fractures Procedure: Addition of TSP to DHS Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : December 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Fracture movement postoperatively [ Time Frame: One year ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00626470     History of Changes
Other Study ID Numbers: TSP Study
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Olavs Hospital:
Trochanter
Femur
Fracture

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