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NCT06146205 | RECRUITING | Hip Fracture


The Hip Fracture Surgical Approach Trial
Sponsor:

Diakonhjemmet Hospital

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

Hip Fracture

Femoral Neck Fracture

Intervention/treatment

Direct lateral approach

SPAIRE

Phase

NA

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
Estimated Enrollment : 406 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : The Hip Fracture Surgical Approach Trial
Actual Study Start Date : 2024-04-30
Estimated Primary Completion Date : 2026-08-30
Estimated Study Completion Date : 2028-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

The Hip Fracture Surgical Approach Trial

Location Details

NCT06146205


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Locations


RECRUITING

Norway,

Diakonhjemmet Hospital

Oslo, Norway, 0319

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