Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures
Primary Purpose
Femur Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
internal fixation (DHS - richard nail)
internal fixation (inflatable PFN by DISCOTEC)
Sponsored by
About this trial
This is an interventional treatment trial for Femur Fracture focused on measuring pertrochanteric femur fracture, DHS, IMN
Eligibility 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
Sites / Locations
- TASMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
DHS fixation
IMN fixation
Outcomes
Primary Outcome Measures
death within 1 year of operation
Secondary Outcome Measures
Full Information
NCT ID
NCT00686023
First Posted
May 27, 2008
Last Updated
May 28, 2008
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00686023
Brief Title
Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures
Official Title
Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Fracture
Keywords
pertrochanteric femur fracture, DHS, IMN
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
DHS fixation
Arm Title
2
Arm Type
Active Comparator
Arm Description
IMN fixation
Intervention Type
Procedure
Intervention Name(s)
internal fixation (DHS - richard nail)
Other Intervention Name(s)
DHS - richard nail
Intervention Description
internal fixation
Intervention Type
Procedure
Intervention Name(s)
internal fixation (inflatable PFN by DISCOTEC)
Other Intervention Name(s)
inflatable PFN by DISCOTEC
Intervention Description
internal fixation
Primary Outcome Measure Information:
Title
death within 1 year of operation
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eli Steinberg, MD
Phone
972-3-6974727
Email
steinberge@tasmc.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eli Steinberg, MD
Organizational Affiliation
TASMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
TASMC
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
eli steinberg, MD
Phone
972-3-6974727
Email
steinberge@tasmc.health.gov.il
12. IPD Sharing Statement
Citations:
PubMed Identifier
16501984
Citation
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. Erratum In: Arch Orthop Trauma Surg. 2006 Dec;126(10):720. Sternberg, Eli [corrected to Steinberg, Ely].
Results Reference
result
PubMed Identifier
14648267
Citation
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.
Results Reference
result
PubMed Identifier
15686241
Citation
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.
Results Reference
result
PubMed Identifier
1587874
Citation
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.
Results Reference
result
PubMed Identifier
9611022
Citation
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.
Results Reference
result
Learn more about this trial
Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures
We'll reach out to this number within 24 hrs