Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures
NCT ID: NCT00686023
Last Updated: 2008-05-29
Study Results
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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UNKNOWN
NA
100 participants
INTERVENTIONAL
2008-06-30
2012-01-31
Brief Summary
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Detailed Description
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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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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
DHS fixation
internal fixation (DHS - richard nail)
internal fixation
2
IMN fixation
internal fixation (inflatable PFN by DISCOTEC)
internal fixation
Interventions
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internal fixation (DHS - richard nail)
internal fixation
internal fixation (inflatable PFN by DISCOTEC)
internal fixation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unilateral
* Age over 60 years
* Low energy trauma
* ASA score 0-3
Exclusion Criteria
* Pathological fractures
* Severe osteoarthritis of the hip joint
* Previous operations on same leg
* ASA score 4-5
60 Years
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
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
Countries
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Central Contacts
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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.
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.
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. doi: 10.1302/0301-620X.74B3.1587874.
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.
Other Identifiers
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TASMC-08-ES-0054
Identifier Type: -
Identifier Source: org_study_id