Hip FracturesNCT03906032
Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture
A study testing TFNA IM Nail and Sliding hip screw in people with Hip Fractures and Gait, Unsteady, run by University Hospital Waterford at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures, Gait, Unsteady, Function
- What is being tested?
- TFNA IM Nail and Sliding hip screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIreland
- Study dates
- 2 Apr 2019to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- OTA Hip fracture grade A1 and A2
- Greater than 18 years old
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled 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
Read the detailed 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.
- Conditions
- Hip Fractures, Gait, Unsteady, Function
- Being tested
- TFNA IM Nail, Sliding hip screw
- Keywords
- Timed up and go, mobility, functional outcome
- Medical subject headings
- Hip Fractures, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFNA IM NailDevice
IM nail
Sliding hip screwDevice
SHS surgical fixation
| Study group | Role | What they receive |
|---|---|---|
| Intra-medullary hip Nail | Experimental | Surgery Receives: Device: TFNA IM Nail |
| Sliding hip screw | Active comparator | Surgery Receives: Device: Sliding hip screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinmeatic Gait parameters at Hip
Rate of change in hip kinematic profile between baseline and subsequent time points,
Measured: 6 months
Secondary outcomes (9)
Length of stay
The duration of hospital stay after this procedure has wide variability between 3 days and weeks to months.
Measured: Through to study completion at one year post operatively.
Change in Heamoglobin concentration post surgery
Haemoglobin (Hb) day two measurement in grams per decilitre (g/dl)
Measured: Day 2 post surgery
Change in Heamatocrit concentration post surgery
Haematocrit day two measurement in litre of cells per litre of blood (L/L)
Measured: Day 2 post surgery
Mortality
Absolute
Measured: At any time point to 1 year post op
Analgesia Use
rate of opiate use
Measured: 5 days
Timed up and go test
Tested measure of mobility and the change between baseline and subsequent time points
Measured: 6 weeks, 6 months, 1 year
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
Measured: 6 weeks, 6 months, 1 year
Radiographic assessment of fracture healing
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)
Measured: 6 weeks, 6 months, 1 year
Radiographic assessment of femoral neck shortening
Radiographic assessment of any change in femoral neck length (in millimetres) between image on date of surgery and the 6 month post surgery image
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start2 Apr 2019
- Primary completion2 Jun 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Waterford
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes
- Responsible party
- Principal investigator, May Cleary, University Hospital Waterford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906032
- Sponsor's protocol ID
- UHWHip#
- Status last verified
- Jul 2025
- First submitted
- 1 Apr 2019
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture
- ClinicalTrials.gov ID
- NCT03906032
- Acronym / sponsor ID
- UHWHip#
- Conditions
- Hip Fractures, Gait, Unsteady, Function
- Keywords
- Timed up and go, mobility, functional outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital WaterfordUniversity, hospital or other
- Collaborators
- DePuy Synthes
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intra-medullary hip Nail | Experimental | Device: TFNA IM NailSurgery |
| Sliding hip screw | Active comparator | Device: Sliding hip screwSurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- OTA Hip fracture grade A1 and A2
- Greater than 18 years old
Key exclusion criteria (11 listed)
- Fracture less than 18 yrs old
- Fracture with lateral wall trochanteric comminution
- Poltrauma
- Concurrent lower limb fractures
- Immobile/wheelchair/bedbound patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TFNA IM NailIM nail | Device | Intra-medullary hip Nail |
| Sliding hip screwSHS surgical fixation | Device | Sliding hip screw |
Primary outcome
Kinmeatic Gait parameters at Hip
Time frame: 6 months
Rate of change in hip kinematic profile between baseline and subsequent time points,
9 secondary outcomes
Length of stay
Time frame: Through to study completion at one year post operatively.
Change in Heamoglobin concentration post surgery
Time frame: Day 2 post surgery
Change in Heamatocrit concentration post surgery
Time frame: Day 2 post surgery
Mortality
Time frame: At any time point to 1 year post op
Analgesia Use
Time frame: 5 days
Timed up and go test
Time frame: 6 weeks, 6 months, 1 year
Harris Hip score
Time frame: 6 weeks, 6 months, 1 year
Radiographic assessment of fracture healing
Time frame: 6 weeks, 6 months, 1 year
Radiographic assessment of femoral neck shortening
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TFNA IM Nail and Sliding hip screw in people with Hip Fractures and Gait, Unsteady, run by University Hospital Waterford at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinmeatic Gait parameters at Hip (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.