NCT00686023

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

May 29, 2008

Status Verified

May 1, 2008

Enrollment Period

3.6 years

First QC Date

May 27, 2008

Last Update Submit

May 28, 2008

Conditions

Femur Fracture

Keywords

pertrochanteric femur fractureDHSIMN

Outcome Measures

Primary Outcomes (1)

  • death within 1 year of operation

    4 years

Study Arms (2)

1

ACTIVE COMPARATOR

DHS fixation

Procedure: internal fixation (DHS - richard nail)

2

ACTIVE COMPARATOR

IMN fixation

Procedure: internal fixation (inflatable PFN by DISCOTEC)

Interventions

internal fixation (DHS - richard nail)PROCEDURE

internal fixation

Also known as: DHS - richard nail
1
internal fixation (inflatable PFN by DISCOTEC)PROCEDURE

internal fixation

Also known as: inflatable PFN by DISCOTEC
2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pertrochanteric femur fracture
  • Unilateral
  • Age over 60 years
  • Low energy trauma
  • ASA score 0-3

You may not qualify if:

  • Reverse oblique fractures
  • Pathological fractures
  • Severe osteoarthritis of the hip joint
  • Previous operations on same leg
  • ASA score 4-5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TASMC

Tel Aviv, Israel

Location

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

    PMID: 16501984RESULT

  • 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.

    PMID: 14648267RESULT

  • 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.

    PMID: 15686241RESULT

  • 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.

    PMID: 1587874RESULT

  • 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.

    PMID: 9611022RESULT

MeSH Terms

Conditions

Femoral Fractures

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Eli Steinberg, MD

    TASMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eli Steinberg, MD

CONTACT

972-3-6974727steinberge@tasmc.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 29, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

May 29, 2008

Record last verified: 2008-05

Locations

IL(1)