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

Primary Purpose

Hip Fractures, Gait, Unsteady, Function

Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
TFNA IM Nail
Sliding hip screw
Sponsored by
University Hospital Waterford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Timed up and go, mobility, functional outcome

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital WaterfordRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intra-medullary hip Nail

Sliding hip screw

Arm Description

Surgery

Surgery

Outcomes

Primary Outcome Measures

Blood Loss
Haemaglobin (Hb) day two measurement.
Blood Loss
Haematocrit (Hct) at day two measurement.
Mortality
Absolute
Analgesia Use
rate of opiate use
Timed up and go test
Tested measure of mobility and the change between baseline and subsequent time points
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.
Kinmeatic Gait parameters at Hip
Rate of change in hip kinmeatic profile between baseline and subsequent time points

Secondary Outcome Measures

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

Full Information

First Posted
April 1, 2019
Last Updated
September 25, 2020
Sponsor
University Hospital Waterford
Collaborators
DePuy Synthes
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1. Study Identification

Unique Protocol Identification Number
NCT03906032
Brief Title
Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture
Official Title
Prospective Randomized Controlled Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2, 2019 (Actual)
Primary Completion Date
April 2, 2022 (Anticipated)
Study Completion Date
April 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Waterford
Collaborators
DePuy Synthes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Gait, Unsteady, Function
Keywords
Timed up and go, mobility, functional outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
352 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intra-medullary hip Nail
Arm Type
Experimental
Arm Description
Surgery
Arm Title
Sliding hip screw
Arm Type
Active Comparator
Arm Description
Surgery
Intervention Type
Device
Intervention Name(s)
TFNA IM Nail
Intervention Description
IM nail
Intervention Type
Device
Intervention Name(s)
Sliding hip screw
Intervention Description
SHS surgical fixation
Primary Outcome Measure Information:
Title
Blood Loss
Description
Haemaglobin (Hb) day two measurement.
Time Frame
Mathematical model Day 2 Hb
Title
Blood Loss
Description
Haematocrit (Hct) at day two measurement.
Time Frame
Mathematical model Day 2 Hct
Title
Mortality
Description
Absolute
Time Frame
At any time point to 1 year post op
Title
Analgesia Use
Description
rate of opiate use
Time Frame
5 days
Title
Timed up and go test
Description
Tested measure of mobility and the change between baseline and subsequent time points
Time Frame
6 weeks, 6 months, 1 year
Title
Harris Hip score
Description
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.
Time Frame
6 weeks, 6 months, 1 year
Title
Kinmeatic Gait parameters at Hip
Description
Rate of change in hip kinmeatic profile between baseline and subsequent time points
Time Frame
6 weeks, 6 months, 1 year
Secondary Outcome Measure Information:
Title
Length of stay
Description
the duration of hospital stay after this procedure has wide variability between 3 days and weeks to months.
Time Frame
Through to study completion at one year post operatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
May Cleary, FRCS
Phone
0035351848000
Email
may.cleary@hse.ie
Facility Information:
Facility Name
University Hospital Waterford
City
Waterford
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
May Cleary
Phone
0035351848000
Email
may.cleary@hse.ie

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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