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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03906032
Other study ID # UHWHip#
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2, 2019
Est. completion date April 2, 2023

Study information

Verified date September 2020
Source University Hospital Waterford
Contact May Cleary, FRCS
Phone 0035351848000
Email may.cleary@hse.ie
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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


Description:

Published work in this field to date has not demonstrated a clear advantage of nailing over hip screw in intertrochanteric proximal femoral fractures. The current lierature focus on outcome questionnaires, pain scores and basic functional tests alone does not delineate the functional benefits clearly enough. 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 impairs gait, including decreased cadence and increased double support time on the injured side.

The difference in cost between a nail and a SHS is a driver to prevent routine use of nailing in this population unless a clear benefit is demonstrated. Fracture union is not a problem for the most part and, as such, the focus must be on achieving better functional outcome, less morbidity and less mortality in this group.

The key question to answer is whether a IM Nail (TFNA) results in a greater functional benefit in A1/A2 intertrochanteric fractures compared with the SHS.


Recruitment information / eligibility

Status Recruiting
Enrollment 352
Est. completion date April 2, 2023
Est. primary completion date April 2, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- OTA Hip fracture grade A1 and A2

- Greater than 60 years old

Exclusion Criteria:

- Polytrauma, high-energy hip fractures, pathological fractures,

- Reverse oblique and sub-trochanteric femoral fractures

- less than 60 years old

Study Design


Intervention

Device:
TFNA IM Nail
IM nail
Sliding hip screw
SHS surgical fixation

Locations

Country Name City State
Ireland University Hospital Waterford Waterford

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Waterford DePuy Synthes

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Loss Haemaglobin (Hb) day two measurement. Mathematical model Day 2 Hb
Primary Blood Loss Haematocrit (Hct) at day two measurement. Mathematical model Day 2 Hct
Primary Mortality Absolute At any time point to 1 year post op
Primary Analgesia Use rate of opiate use 5 days
Primary Timed up and go test Tested measure of mobility and the change between baseline and subsequent time points 6 weeks, 6 months, 1 year
Primary Harris Hip score 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. 6 weeks, 6 months, 1 year
Primary Kinmeatic Gait parameters at Hip Rate of change in hip kinmeatic profile between baseline and subsequent time points 6 weeks, 6 months, 1 year
Secondary Length of stay the duration of hospital stay after this procedure has wide variability between 3 days and weeks to months. Through to study completion at one year post operatively.
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