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Completed

NCT Number: NCT03906032

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Waterford

Waterford, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TFNA IM Nail

Device

IM nail

sliding hip screw

Device

SHS surgical fixation

Primary outcomes

  1. Kinmeatic Gait parameters at Hip

    Time frame: 6 months

    Rate of change in hip kinematic profile between baseline and subsequent time points,

Secondary outcomes

  1. Length of stay

    Time frame: Through to study completion at one year post operatively.

    The duration of hospital stay after this procedure has wide variability between 3 days and weeks to months.

  2. Change in Heamoglobin concentration post surgery

    Time frame: Day 2 post surgery

    Haemoglobin (Hb) day two measurement in grams per decilitre (g/dl)

  3. Change in Heamatocrit concentration post surgery

    Time frame: Day 2 post surgery

    Haematocrit day two measurement in litre of cells per litre of blood (L/L)

  4. Mortality

    Time frame: At any time point to 1 year post op

    Absolute

  5. Analgesia Use

    Time frame: 5 days

    rate of opiate use

  6. Timed up and go test

    Time frame: 6 weeks, 6 months, 1 year

    Tested measure of mobility and the change between baseline and subsequent time points

  7. Harris Hip score

    Time frame: 6 weeks, 6 months, 1 year

    Functional scale of hip pain and the change between baseline and subsequents time points. Maximum score: 100 points indicating excellent function, minimum score 0 points indicating poor function

  8. Radiographic assessment of fracture healing

    Time frame: 6 weeks, 6 months, 1 year

    Radiographic union as observed on plain radiographs at the stated time intervals (radiographic union score for hip total score of 10 - 30 points, minimum 10, maximum 30)

  9. Radiographic assessment of femoral neck shortening

    Time frame: 6 months

    Radiographic assessment of any change in femoral neck length (in millimetres) between image on date of surgery and the 6 month post surgery image

Sponsors and collaborators

Lead sponsor

University Hospital Waterford

Other

Collaborators

  • DePuy Synthes

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2019
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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