Clinical trial NCT03906032: 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
Overall status: RECRUITING
Phase: NA
Conditions: Hip Fractures
Gait, Unsteady
Function
Keywords: Timed up and go
mobility
functional outcome
Lead sponsor: University Hospital Waterford
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
First posted: 2019-04-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Kinmeatic Gait parameters at Hip
timeFrame: 6 months
Secondary outcomes:
measure: Length of stay
timeFrame: Through to study completion at one year post operatively.
measure: Change in Heamoglobin concentration post surgery
timeFrame: Day 2 post surgery
measure: Change in Heamatocrit concentration post surgery
timeFrame: Day 2 post surgery
measure: Mortality
timeFrame: At any time point to 1 year post op
measure: Analgesia Use
timeFrame: 5 days
measure: Timed up and go test
timeFrame: 6 weeks, 6 months, 1 year
measure: Harris Hip score
timeFrame: 6 weeks, 6 months, 1 year
measure: Radiographic assessment of fracture healing
timeFrame: 6 weeks, 6 months, 1 year
measure: Radiographic assessment of femoral neck shortening
timeFrame: 6 months
Other outcomes:
Locations:
city: Waterford
country: Ireland
facility: University Hospital Waterford
Study officials:
References: