Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures

Femur Fracture Clinical Trial

Official title:

Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00686023
• Other study ID #: TASMC-08-ES-0054
• Status: Not yet recruiting
• Phase: N/A
• First received: May 27, 2008
• Last updated: May 28, 2008
• Start date: June 2008
• Est. completion date: January 2012

Study information

• Verified date: May 2008
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Eli Steinberg, MD
• Phone: 972-3-6974727
• Email: steinberge[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone

Intervention

Procedure:
• internal fixation (DHS - richard nail)
internal fixation
• internal fixation (inflatable PFN by DISCOTEC)
internal fixation

Locations

Country	Name	City	State
Israel	TASMC	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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: — View 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 pati — View 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. — View 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. — View 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death within 1 year of operation		4 years	Yes