HIFSAT: The Hip Fracture Surgical Approach Trial

Sponsor

Diakonhjemmet Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06146205

Collaborator

Oslo University Hospital (Other), University Hospital, Akershus (Other)

406

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fracture Femoral Neck Fracture	Procedure: Direct lateral approach Procedure: SPAIRE	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

406 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Hip Fracture Surgical Approach Trial

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2028

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Harris Hip Score ( HHS) [4 months]
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).

Secondary Outcome Measures

Harris Hip Score (HHS) [12 and 24 months]
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).
Oxford Hip score [0, 4,12 and 24 months]
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.
EuroQol-5d-5l [4,12 and 24 months]
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.
Trendelenburg test [4,12 and 24 months]
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.
New Mobility Score (NMS) [4,12 and 24 months]
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.
Short Physical Performance Battery (SPPB) [4, 12, an 24 months]
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.
Numerical Pain Rate Scale( NPRS) [4, 12 and 24 months]
Unidimensional measure of pain intensity in adults, describing pain extreme from 0 no pain at all to 10 the worst pain imaginable.
Blood transfusion [1st day after surgery until discharge, assessed up to 10 days]
Units of blood transfusion given to the patient during admission
Duration of surgery [1.st day after surgery]
Duration of the operation in minutes
Conventional radiographs of the operated hip [1.st day after surgery and at 4 months after surgery]
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
Adverse events [0-24 months]
Any adverse events will be recorded during the whole study period

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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