Clinical trial NCT06146205: The Hip Fracture Surgical Approach Trial
Official title: The Hip Fracture Surgical Approach Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Fracture
Femoral Neck Fracture
Keywords: Fragility fracture
Surgical approach
Hemiarthroplasty
SPAIRE
Direct Lateral Approach
Hip Surgery
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: University Hospital, Akershus
First posted: 2023-11-24
Enrollment: 406
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The HIFSAT study will compare the standard direct lateral approach to hemiarthroplasty to a new muscle sparing approach (SPAIRE) in femoral neck fracture patients.

Detailed description: Femoral neck fractures are mostly treated with a hemiarthroplasty, where the fractured femoral head is replaced with a metal implant. The most common surgical approach to hemiarthroplasty has been the lateral approach, in which the gluteus medius tendon is partially released from the greater trochanter. Hip pain and limping is not uncommon after this approach has been used. A new surgical approach (SPAIRE) has been developed to alleviate this problem, and in this method the surgeon approaches the injured hip joint from posterior, preserving most of the muscles and tendons around the hip. This trial is designed to assess if this new SPAIRE approach leads to better results than the lateral approach in patients with femoral neck fractures.

Eligibility criteria: Inclusion Criteria:

* Femoral neck fracture
* Clinical indication for hemiarthroplasty
* Age over 50 years

Exclusion Criteria:

* Previous hip implants in the same hip
* Patients assessed to be in a terminal state with an expected survival of less than 1 week
* Other factors that makes follow-up impossible

Primary outcomes:
measure: Harris Hip Score ( HHS)
timeFrame: 4 months
Secondary outcomes:
measure: Harris Hip Score (HHS)
timeFrame: 12 and 24 months
measure: Oxford Hip score
timeFrame: 4,12 and 24 months
measure: EuroQol-5d-5l
timeFrame: 4,12 and 24 months
measure: Trendelenburg test
timeFrame: 4,12 and 24 months
measure: New Mobility Score (NMS)
timeFrame: 4,12 and 24 months
measure: Short Physical Performance Battery (SPPB)
timeFrame: 4, 12, an 24 months
measure: Numerical Pain Rate Scale( NPRS)
timeFrame: 4, 12 and 24 months
measure: Duration of surgery
timeFrame: 1.st day after surgery
measure: Preferred Walking Speed
timeFrame: 4,12 and 24 months
measure: Repeated Chair Stand Test
timeFrame: 4,12 and 24 months
measure: Cumulated Ambulation Score
timeFrame: 1-5 days after surgery
measure: Timed up and go test
timeFrame: 4,12 and 24 months
measure: Use of analgesia during admission
timeFrame: 1. day after surgery
measure: Adverse events
timeFrame: 0-24 months
measure: Days Alive At Home (DAH)
timeFrame: 4,12 and 24 months
Other outcomes:
measure: Grip strength
timeFrame: Day 1-5 after surgery, 4,12 and 24 months
measure: Patient Acceptable symptom State
timeFrame: 4,12 and 24 months
measure: Blood transfusion
timeFrame: 1st day after surgery until discharge, assessed up to 10 days
measure: Conventional radiographs of the operated hip
timeFrame: 1.st day after surgery and at 4 months after surgery
measure: Body Mass Index
timeFrame: 4, 12 and 24 months
measure: Place of return from hospital
timeFrame: 4 months
measure: Clinical Frailty Scale
timeFrame: 4, 12 and 24 months
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
Study officials:
affiliation: Diakonhjemmet Hospital
name: Siri Lillegraven, PhD
role: STUDY_CHAIR
References: