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

History of Changes

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:

MedlinePlus related topics: Fractures

U.S. FDA Resources

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

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:

Folman Y, Ron N, Shabat S, Hopp M, Steinberg E. Peritrochanteric fractures treated with the Fixion expandable proximal femoral nail: technical note and report of early results. Arch Orthop Trauma Surg. 2006 Apr;126(3):211-4. Epub 2006 Feb 24. Erratum in: Arch Orthop Trauma Surg. 2006 Dec;126(10):720. Sternberg, Eli [corrected to Steinberg, Ely].

Lepore L, Lepore S, Maffulli N. Intramedullary nailing of the femur with an inflatable self-locking nail: comparison with locked nailing. J Orthop Sci. 2003;8(6):796-801.

Pajarinen J, Lindahl J, Michelsson O, Savolainen V, Hirvensalo E. Pertrochanteric femoral fractures treated with a dynamic hip screw or a proximal femoral nail. A randomised study comparing post-operative rehabilitation. J Bone Joint Surg Br. 2005 Jan;87(1):76-81.

Leung KS, So WS, Shen WY, Hui PW. Gamma nails and dynamic hip screws for peritrochanteric fractures. A randomised prospective study in elderly patients. J Bone Joint Surg Br. 1992 May;74(3):345-51.

Hardy DC, Descamps PY, Krallis P, Fabeck L, Smets P, Bertens CL, Delince PE. Use of an intramedullary hip-screw compared with a compression hip-screw with a plate for intertrochanteric femoral fractures. A prospective, randomized study of one hundred patients. J Bone Joint Surg Am. 1998 May;80(5):618-30.

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 May 23, 2013

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