Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00686023
First received: May 27, 2008
Last updated: May 28, 2008
Last verified: May 2008
  Purpose

Hypothesis: Inflatable intra medullary femoral nailing is superior to DHS in terms of blood loss, operative complications and postoperative rehabilitation in the management of pertrochanteric femur neck fractures.


Condition Intervention
Femur Fracture
Procedure: internal fixation (DHS - richard nail)
Procedure: internal fixation (inflatable PFN by DISCOTEC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • death within 1 year of operation [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: June 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
DHS fixation
Procedure: internal fixation (DHS - richard nail)
internal fixation
Other Name: DHS - richard nail
Active Comparator: 2
IMN fixation
Procedure: internal fixation (inflatable PFN by DISCOTEC)
internal fixation
Other Name: inflatable PFN by DISCOTEC

Detailed Description:

patients with pertrochanteric fractures of the femur will be randomly assigned to one of 2 groups.

group 1 will undergo internal fixation using a DHS device. group 2 will undergo internal fixation using an inflatable intramedullary femoral nail device post operative care will be the same including DVT prophylaxis, early mobilization.

weight baring will be aloud in cases of a stable fracture (EVANS 1-3) non weight bearing until callus bridge in patients with unstable fractures (EVANS 4-6)

outcomes: death within first year

postoperative complications length of hospitalization time to mobilization functional score reontgenic evaluation

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pertrochanteric femur fracture
  • Unilateral
  • Age over 60 years
  • Low energy trauma
  • ASA score 0-3

Exclusion Criteria:

  • Reverse oblique fractures
  • Pathological fractures
  • Severe osteoarthritis of the hip joint
  • Previous operations on same leg
  • ASA score 4-5
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00686023

Contacts
Contact: Eli Steinberg, MD 972-3-6974727 steinberge@tasmc.health.gov.il

Locations
Israel
TASMC Not yet recruiting
Tel Aviv, Israel
Contact: eli steinberg, MD    972-3-6974727    steinberge@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Eli Steinberg, MD TASMC
  More Information

Publications:
Responsible Party: MD Eli Steinberg, orthopedic trauma manager department B, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00686023     History of Changes
Other Study ID Numbers: TASMC-08-ES-0054
Study First Received: May 27, 2008
Last Updated: May 28, 2008
Health Authority: Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:
pertrochanteric femur fracture
DHS
IMN

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

ClinicalTrials.gov processed this record on July 31, 2014