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Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture

U

University Hospital Waterford

Status

Completed

Conditions

Hip Fractures
Gait, Unsteady
Function

Treatments

Device: Sliding hip screw
Device: TFNA IM Nail

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03906032
UHWHip#

Details and patient eligibility

About

Shortening of the abductor lever arm is a particular concern with the SHS, and the resultant biomechanical alterations may impair gait, including decreased cadence, gait speed and increased double support time on the injured side.

The use of an IM nail device may reduce shortening and improve functional parameters in this patient cohort

Full description

Published work in this field to date has not demonstrated an advantage of nailing over hip screw in intertrochanteric proximal femoral fractures. The current literature focus on outcome questionnaires, pain scores and basic functional tests alone may not delineate all functional benefits. A key factor in whether a person, post hip fracture, returns to independent living is gait speed. The cost implications on the healthcare provider of having 30% of this ever increasing group losing their independence and requiring admission to a care facility post hip fracture is a growing problem.

Shortening of the abductor lever arm is a particular concern with the SHS, and the resultant biomechanical alterations may impair gait, including decreased cadence and increased double support time on the injured side.

The cost differential between a nail and a SHS is a barrier to routine use of nailing in this population unless a clear benefit is demonstrated. Fracture nonunion is uncommon in this injury however improving functional outcome and reducing morbidity and mortality in this group is important.

In this prospective randomised study, the investigators examine whether an intramedullary nail (TFNA) results in a greater functional benefit in A1/A2 intertrochanteric fractures compared with the SHS, in terms of gait speed and other objective gait assessments, as well as other established post operative outcome measures.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • OTA Hip fracture grade A1 and A2
  • Greater than 18 years old

Exclusion criteria

  • Fracture less than 18 yrs old
  • Fracture with lateral wall trochanteric comminution
  • Poltrauma
  • Concurrent lower limb fractures
  • Immobile/wheelchair/bedbound patients
  • High energy hip fractures
  • Pathological fractures
  • Reverse oblique and sub-trochanteric femoral fractures which are considered obligate TFNA at our centre
  • Open wounds on affected limb
  • Active psoriasis or other dermatological conditions at affected area
  • Unable to gain consent from patient or patient's NOK

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

150 participants in 2 patient groups

Intra-medullary hip Nail
Experimental group
Description:
Surgery
Treatment:
Device: TFNA IM Nail
Sliding hip screw
Active Comparator group
Description:
Surgery
Treatment:
Device: Sliding hip screw

Trial contacts and locations

1

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Central trial contact

May Cleary, FRCS

Data sourced from clinicaltrials.gov

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