The Hip Fracture Surgical Approach Trial (HIFSAT)

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

Study Overview

• Status: Recruiting
• Conditions: Hip Fracture; Femoral Neck Fracture
• Intervention / Treatment: Procedure: Direct lateral approach; Procedure: SPAIRE

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.

• Study Type: Interventional
• Enrollment (Estimated): 406
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maren Paus, MD; Phone Number: +4722454755; Email: maren.paus@diakonsyk.no
• Study Contact Backup: Name: Mads Sundet, PhD; Email: mads.sundet@diakonsyk.no

Study Locations

• Norway
  • Oslo, Norway, 0319
    • Recruiting
    • Diakonhjemmet Hospital
    • Contact: Maren Paus, MD; Phone Number: +4722454755; Email: maren.paus@diakonsyk.no
    • Contact: Mads Sundet, PhD; Phone Number: +4722451500; Email: mads.sundet@diakonsyk.no
    • Principal Investigator: Mads Sundet, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Direct lateral approach	Procedure: Direct lateral approach; The hip joint is approached from laterally, and parts of the gluteus medius tendon is released from the greater trochanter before the hip joint is entered from the anterior side.; Other Names: Hardinge approach
Experimental: Spaire approach	Procedure: SPAIRE; The hip joint is entered from posterior, and the approach preserves the external rotators of the hip joint.; Other Names: Muscle-sparing modification of the posterior approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score ( HHS)	Harris Hip Score (HHS) is an outcome measure for hip-related symptoms. The score is based on both patient-reported information and clinical examination, and is administered by a qualified health care professional. It covers four domains: Pain, function, absence of deformity and range of motion. The score ranges from 0 (worst) to 100 (best).	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score (HHS)	Harris Hip Score (HHS) is an outcome measure for hip-related symptoms. The score is based on both patient-reported information and clinical examination, and is administered by a qualified health care professional. It covers four domains: Pain, function, presence of deformity and range of motion. The score ranges from 0 (worst) to 100 (best).	12 and 24 months
Oxford Hip score	Oxford Hip Score(OHS) is a patient reported outcome measure( PROM), OHS is designed to assess outcome after total hip replacement. It has 6 questions on pain and 6 questions on mobility. 5 categories of answer from worst to best. The range is 0-48.	4,12 and 24 months
EuroQol-5d-5l	EuroQol-5d-5l is a descriptive system comprises 5 dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state, and these digits can be converted into a single numerical value reflecting how the health state is according to the preferences of the general population of a country/region.	4,12 and 24 months
Trendelenburg test	This is a test to identify weakness in gluteal muscles, that can be seen in patients after hip surgery. Unilateral weakness in the gluteal muscles can for instance because nerve damage, trauma to the muscle or rupture of the tendon. The test will be performed as described by Hardcastle and Wade. The patient will be asked to raise their foot from the ground with 30º of hip flexion. The patient will be instructed to raise the non-stance side of the pelvis as high as possible with the examiner supporting the patient by holding their hands if needed. If the patient is not able to maintain this position for 30 seconds, or not being able to raise the hip of the non-stance side to above the level of the stance-side, the Trendelenburg test is considered positive.	4,12 and 24 months
New Mobility Score (NMS)	NMS consists of 3 questions about ambulation indoor, outdoor and the ability to go shopping. Each question has 4 alternative answers yielding 0-3 points, and the maximum score is 9.	4,12 and 24 months
Short Physical Performance Battery (SPPB)	The Short Physical Performance Battery is an assessment tool made specific for screening of physical function among older adults. SPPB has 3 different tests: Balance, walking speed and rising from a chair. Scorings range from 0-12, best possible is 12.	4, 12, an 24 months
Numerical Pain Rate Scale( NPRS)	Unidimensional measure of pain intensity in adults, describing pain extreme from 0 no pain at all to 10 the worst pain imaginable.	4, 12 and 24 months
Duration of surgery	Duration of the operation in minutes	1.st day after surgery
Preferred Walking Speed	A four-meter distance is marked on the floor, and the patients are instructed to walk this distance in their normal speed, as if they were walking down a street. The distance is walked twice, and the fastest speed is recorded. The subject can use any walking aids, and this is recorded.	4,12 and 24 months
Repeated Chair Stand Test	In the repeated chair stand test the participants are asked to fold their arms across their chest (the armrests shall not be not used) and stand up from the chair 5 times. This is timed by the examiner, and points are given from 0 to 4	4,12 and 24 months
Cumulated Ambulation Score	This will be recorded at day 1-3 for all patients. This score assesses the patients' early mobility by evaluating their ability to rise from bed, rise from a chair and walk indoor (walking aids permitted).	1-5 days after surgery
Timed up and go test	This test measures the time that the person uses to rise from a chair, walk three meters, turn around and walk back to the chair, and sit down again, turning 180 degrees. The person can use any mobility aids that he/she would normally use. The TUG test is being scored by the total time measured	4,12 and 24 months
Use of analgesia during admission	Analgesia during the first calendar day after surgery will be recorded as morphine equivalents according to a calculation table published by the Norwegian Directorate of Health.	1. day after surgery
Adverse events	Any adverse events will be recorded during the whole study period	0-24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip strength	associated with low grip strength. The measurements will be taken with the patient sitting, with the elbow in 90° flexion and the shoulder adducted and neutrally rotated. The second handle position will be used for all participants. Two trials on each side will be conducted, starting with the dominant hand	Day 1-5 after surgery, 4,12 and 24 months
Patient Acceptable symptom State	Question about the patient´s satisfaction of the current state of their hip, and another question on whether they consider the treatment of their hip fracture to be a success or failure. They will also record a visual analogue scale of their satisfaction with the result of the surgery, ranging from "very satisfied" to "very dissatisfied".	4,12 and 24 months
Blood transfusion	Units of blood transfusion given to the patient during admission	1st day after surgery until discharge, assessed up to 10 days
Conventional radiographs of the operated hip	Conventional radiographs will be taken postoperatively and at 4 months according to the standardized procedures for post-operative hip examinations of the radiology department. Using specialized computer software (Sectra Workstation IDS7 v.21 with orthopedic templating module Sectra Orthostation v15.1, Sectra AB, Linköping, Sweden), leg length difference, and hip offset compared to the uninjured hip will be recorded. In patients with a contralateral hip fracture this is not possible, but some of these patients will have available pre-fracture examinations that can be utilized for comparison. Femoral stem varus/valgus angulation (frontal view) and retroversion/anteversion (lateral view) will also be recorded	1.st day after surgery and at 4 months after surgery
Body Mass Index	Recorded with objective weight and height measurements.	4, 12 and 24 months
Place of return from hospital	Place of return from hospital will be recorded, and at later visits the type of dwelling since the last visit will be recorded. We will differentiate between institution dwelling and community dwelling.	4 months
Clinical Frailty Scale	Assessment of frail patients, grades from 1 (very fit patient) to 9 (terminally ill).	4, 12 and 24 months

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital
• Collaborators: Oslo University Hospital; University Hospital, Akershus
• Investigators: Study Chair: Siri Lillegraven, PhD, Diakonhjemmet Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Hemiarthroplasty; Surgical approach; Hip Surgery; Direct Lateral Approach; Fragility fracture; SPAIRE
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: HIFSAT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No