Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures

NCT ID: NCT00686023

Last Updated: 2008-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Femur Fracture

Keywords

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pertrochanteric femur fracture DHS IMN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

DHS fixation

Group Type ACTIVE_COMPARATOR

internal fixation (DHS - richard nail)

Intervention Type PROCEDURE

internal fixation

2

IMN fixation

Group Type ACTIVE_COMPARATOR

internal fixation (inflatable PFN by DISCOTEC)

Intervention Type PROCEDURE

internal fixation

Interventions

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internal fixation (DHS - richard nail)

internal fixation

Intervention Type PROCEDURE

internal fixation (inflatable PFN by DISCOTEC)

internal fixation

Intervention Type PROCEDURE

Other Intervention Names

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DHS - richard nail inflatable PFN by DISCOTEC

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel-Aviv Sourasky Medical Center

Principal Investigators

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Eli Steinberg, MD

Role: PRINCIPAL_INVESTIGATOR

TASMC

Locations

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TASMC

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Eli Steinberg, MD

Role: CONTACT

Phone: 972-3-6974727

Email: [email protected]

Facility Contacts

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eli steinberg, MD

Role: primary

References

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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. doi: 10.1007/s00402-006-0110-0. Epub 2006 Feb 24.

Reference Type RESULT
PMID: 16501984 (View on PubMed)

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. doi: 10.1007/s00776-003-0709-8.

Reference Type RESULT
PMID: 14648267 (View on PubMed)

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.

Reference Type RESULT
PMID: 15686241 (View on PubMed)

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. doi: 10.1302/0301-620X.74B3.1587874.

Reference Type RESULT
PMID: 1587874 (View on PubMed)

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. doi: 10.2106/00004623-199805000-00002.

Reference Type RESULT
PMID: 9611022 (View on PubMed)

Other Identifiers

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TASMC-08-ES-0054

Identifier Type: -

Identifier Source: org_study_id