Hip Fractures, Gait, Unsteady, Function
Conditions
Keywords
Timed up and go, mobility, functional outcome
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.
Interventions
DEVICETFNA IM Nail
IM nail
DEVICESliding hip screw
SHS surgical fixation
Sponsors
DePuy Synthes
University Hospital Waterford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Simple randomization technique using an online random number generator will be utilized. Sequential sealed envelopes with group allocation will be opened at the time of the daily trauma meeting and the appropriate plan made for the patient. Patients are randomized according to 3 mobility groups - independent, walking stick/crutch or walking frame.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* OTA Hip fracture grade A1 and A2 * Greater than 18 years old
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kinmeatic Gait parameters at Hip | 6 months | Rate of change in hip kinematic profile between baseline and subsequent time points, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Ireland
Outcome results
None listed