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

NCT03906032 | Completed

• 1 other identifier: UHWHip#
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Fractures; Gait, Unsteady; Function

Keywords

Timed up and go; mobility; functional outcome

Outcome Measures

Primary Outcomes (1)

• Kinmeatic Gait parameters at Hip

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

  6 months

Secondary Outcomes (9)

• Length of stay

  Through to study completion at one year post operatively.

• Change in Heamoglobin concentration post surgery

  Day 2 post surgery

• Change in Heamatocrit concentration post surgery

  Day 2 post surgery

• Mortality

  At any time point to 1 year post op

• Analgesia Use

  5 days

Study Arms (2)

Intra-medullary hip Nail

EXPERIMENTAL

Surgery

Device: TFNA IM Nail

Sliding hip screw

ACTIVE COMPARATOR

Surgery

Device: Sliding hip screw

Interventions

TFNA IM Nail DEVICE

IM nail

Intra-medullary hip Nail

Sliding hip screw DEVICE

SHS surgical fixation

Sliding hip screw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Waterford: lead
• DePuy Synthes: collaborator

Study Sites (1)

University Hospital Waterford

Waterford, Ireland

Location

MeSH Terms

Conditions

Hip Fractures; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Simple randomization technique using an online random number generator will be utilized. Sequential sealed envelopes with group allocation will be opened at the time of the daily trauma meeting and the appropriate plan made for the patient. Patients are randomized according to 3 mobility groups - independent, walking stick/crutch or walking frame.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: Gait speed (mean velocity): Sample size calculations are based on a two-sample, two-sided t-test for a difference in means with 80% power, a 5% type 1 error rate. The minimal clinically important difference (MCID) in gait speed is stated in the literature as between 0.10 - 0.20 m/s. We considered treatment effect of 0.2 m/s (while assuming a SD of 0.3). The resulting total sample sizes for this effect is 74 patients at the 6 months post-operative timeframe. A significant attrition rate (50%) for this population will be allowed for by additional recruitment of \>150 participants

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 8, 2019
• Study Start: April 2, 2019
• Primary Completion: June 2, 2025
• Study Completion: July 2, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)