The Hip Fracture Surgical Approach Trial (HIFSAT)

Diakonhjemmet Hospital

Status: Enrolling

Conditions: Hip Fracture; Femoral Neck Fracture

Treatments: Procedure: Direct lateral approach; Procedure: SPAIRE

Study type: Interventional

Funder types: Other

Identifiers

NCT06146205

HIFSAT

Details and patient eligibility

About

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

Full 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.

Enrollment: 406 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

406 participants in 2 patient groups

Direct lateral approach

Active Comparator group

Treatment:

Procedure: Direct lateral approach

Spaire approach

Experimental group

Treatment:

Procedure: SPAIRE