The Hip Fracture Surgical Approach Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

406 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2028-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hip Fracture Femoral Neck Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Direct lateral approach

Group Type ACTIVE_COMPARATOR

Direct lateral approach

Intervention Type PROCEDURE

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.

Spaire approach

Group Type EXPERIMENTAL

SPAIRE

Intervention Type PROCEDURE

The hip joint is entered from posterior, and the approach preserves the external rotators of the hip joint.

Interventions

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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.

Intervention Type PROCEDURE

SPAIRE

The hip joint is entered from posterior, and the approach preserves the external rotators of the hip joint.

Intervention Type PROCEDURE

Other Intervention Names

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Hardinge approach Muscle-sparing modification of the posterior approach

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No