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Comparison of Gamma Nail Versus Dynamic Hip Screw for the Treatment of Unstable Intertrochanteric Fractures

W

Wolfson Medical Center (WMC)

Status

Unknown

Conditions

Intertrochanteric Femoral Fractures

Treatments

Device: Gamma-3 Nail
Device: DHS

Study type

Interventional

Funder types

Other

Identifiers

NCT01173744
0076-10-WOMC

Details and patient eligibility

About

The objective of the study is to examine the treatment of unstable Intertrochanteric fractures with the short Gamma nail, compared to the use of the dynamic hip screw (DHS).

This is a prospective study. Sixty patients with unstable Intertrochanteric fractures will be randomized to be treated using either Gamma nail or DHS. The patients will be followed for 12 months. The primary endpoint is the clinical outcome as measured by the Merle d'Aubigne and Postelhip score.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Acute Intertrochanteric fracture - A1-32 AO/OTA
  • Abbreviated mental score >6
  • Community ambulator (pre-fracture state)

Exclusion criteria

  • Previous arthritis
  • Pathological fracture
  • Chronic corticosteroid use
  • Concomitant lower extremity fractures

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Gamma-3 Nail
Experimental group
Treatment:
Device: Gamma-3 Nail
DHS
Active Comparator group
Treatment:
Device: DHS

Trial contacts and locations

1

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Central trial contact

Dror Lakstein, MD

Data sourced from clinicaltrials.gov

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