Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture
- Conditions
- Gait, UnsteadyFunctionHip Fractures
- Interventions
- Device: TFNA IM NailDevice: Sliding hip screw
- Registration Number
- NCT03906032
- Lead Sponsor
- University Hospital Waterford
- 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- OTA Hip fracture grade A1 and A2
- Greater than 18 years old
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intra-medullary hip Nail TFNA IM Nail Surgery Sliding hip screw Sliding hip screw Surgery
- Primary Outcome Measures
Name Time Method Kinmeatic Gait parameters at Hip 6 months Rate of change in hip kinematic profile between baseline and subsequent time points,
- Secondary Outcome Measures
Name Time Method Length of stay 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.
Change in Heamoglobin concentration post surgery Day 2 post surgery Haemoglobin (Hb) day two measurement in grams per decilitre (g/dl)
Change in Heamatocrit concentration post surgery Day 2 post surgery Haematocrit day two measurement in litre of cells per litre of blood (L/L)
Mortality At any time point to 1 year post op Absolute
Analgesia Use 5 days rate of opiate use
Timed up and go test 6 weeks, 6 months, 1 year Tested measure of mobility and the change between baseline and subsequent time points
Harris Hip score 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
Radiographic assessment of fracture healing 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)
Radiographic assessment of femoral neck shortening 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
Trial Locations
- Locations (1)
University Hospital Waterford
🇮🇪Waterford, Ireland