University Hospital Waterford
Waterford, Ireland
NCT Number: NCT03906032
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Waterford, Ireland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IM nail
SHS surgical fixation
Time frame: 6 months
Rate of change in hip kinematic profile between baseline and subsequent time points,
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.
Time frame: Day 2 post surgery
Haemoglobin (Hb) day two measurement in grams per decilitre (g/dl)
Time frame: Day 2 post surgery
Haematocrit day two measurement in litre of cells per litre of blood (L/L)
Time frame: At any time point to 1 year post op
Absolute
Time frame: 5 days
rate of opiate use
Time frame: 6 weeks, 6 months, 1 year
Tested measure of mobility and the change between baseline and subsequent time points
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
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)
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
University Hospital Waterford
Other
Prospective Randomized Controlled Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture
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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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