NCT06146205

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
476

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Apr 2024Mar 2028

First Submitted

Initial submission to the registry

November 8, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

April 30, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.3 years

First QC Date

November 8, 2023

Last Update Submit

March 25, 2026

Conditions

Hip FractureFemoral Neck Fracture

Keywords

Fragility fractureSurgical approachHemiarthroplastySPAIREDirect Lateral ApproachHip Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • Harris Hip Score (HHS)

    12 and 24 months

  • Oxford Hip score

    4,12 and 24 months

  • EuroQol-5d-5l

    4,12 and 24 months

  • Trendelenburg test

    4,12 and 24 months

  • New Mobility Score (NMS)

    4,12 and 24 months

  • +10 more secondary outcomes

Other Outcomes (7)

  • Grip strength

    Day 1-5 after surgery, 4,12 and 24 months

  • Patient Acceptable symptom State

    4,12 and 24 months

  • Blood transfusion

    1st day after surgery until discharge, assessed up to 10 days

  • +4 more other outcomes

Study Arms (2)

Direct lateral approach

ACTIVE COMPARATOR
Procedure: Direct lateral approach

Spaire approach

EXPERIMENTAL
Procedure: SPAIRE

Interventions

SPAIREPROCEDURE

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

Also known as: Muscle-sparing modification of the posterior approach
Spaire approach
Direct lateral approachPROCEDURE

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.

Also known as: Hardinge approach
Direct lateral approach

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Femoral neck fracture
  • Clinical indication for hemiarthroplasty
  • Age over 50 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diakonhjemmet Hospital

Oslo, 0319, Norway

Location

MeSH Terms

Conditions

Hip FracturesFemoral Neck Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Siri Lillegraven, PhD

    Diakonhjemmet Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 24, 2023

Study Start

April 30, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

March 30, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

NO(1)