NCT02028468

Brief Summary

Hemiarthroplasty is a well established treatment of Femoral Neck Fractures in the Elderly. During the last decade the use of Minimal Invasive Surgical( MIS) approaches have been increasing. Our hypothesis is that Patients with a Femoral Neck Fracture may benefit from a MIS approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 3, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
25 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2022

Completed
Last Updated

November 10, 2022

Status Verified

March 1, 2022

Enrollment Period

4.1 years

First QC Date

January 3, 2014

Last Update Submit

November 9, 2022

Conditions

Femoral Neck Fracture

Keywords

Femoral Neck FractureAnterolateral approachTrans-gluteal approachWatson Jones approachHardinge approach

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale Pain and Patient Satisfaction

    Pre and postoperative, 3 and 12 Months

Secondary Outcomes (4)

  • Timed up and go

    postoperative, 3 and 12 Monthes

  • Harris Hip Score

    Pre / Postoperative, 3 and 12 Months

  • Hip Osteoarthritis Disability Score

    Postoperative, 3 and 12 Months

  • EuroQol

    Postoperative, 3 and 12 Months

Study Arms (2)

Anterolateral Approach

ACTIVE COMPARATOR

Patient Operated with Watson Jones Approach

Procedure: hemiarthroplasty

Trans-gluteal Approach

ACTIVE COMPARATOR

Patient operated with Trans-gluteal Hardinge Approach

Procedure: hemiarthroplasty

Interventions

hemiarthroplastyPROCEDURE
Anterolateral ApproachTrans-gluteal Approach

Eligibility Criteria

Age70 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may not qualify if:

  • Dementia, Infection Not Suitable for Hemiarthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sorlandet Hospital

Kristiansand, 4604, Norway

Location

Related Publications (1)

  • Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg OH, Pripp AH, Nordsletten L. Biomarkers of muscle damage increased in anterolateral compared to direct lateral approach to the hip in hemiarthroplasty: no correlation with clinical outcome : Short-term analysis of secondary outcomes from a randomized clinical trial in patients with a displaced femoral neck fracture. Osteoporos Int. 2018 Aug;29(8):1853-1860. doi: 10.1007/s00198-018-4557-y. Epub 2018 May 22.

    PMID: 29789919DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Hemiarthroplasty

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Lars Nordsletten, Professor

    University of Oslo Ullevål

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 3, 2014

First Posted

January 7, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 11, 2022

Last Updated

November 10, 2022

Record last verified: 2022-03

Locations

NO(1)