We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00686023
First Posted: May 29, 2008
Last Update Posted: May 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tel-Aviv Sourasky Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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
First Submitted: May 27, 2008
First Posted: May 29, 2008
Last Update Posted: May 29, 2008
Last Verified: May 2008

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

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