NCT03909815

Brief Summary

Our aim is to develop a strategy that reduces the risk of dislocations after total hip arthroplasty surgery performed due to femoral neck fracture. We therefore perform a register-nested, pragmatic, randomized controlled trial to investigate the safety and efficacy of dual mobility cups that were designed to minimize the risk of dislocation in the large and fragile group of elderly patients with femoral neck fractures.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

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

April 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

January 17, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2025

Completed
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

5.7 years

First QC Date

April 8, 2019

Last Update Submit

September 29, 2025

Conditions

Femoral Neck Fractures

Keywords

total hip arthroplastydual mobility cupdislocationmortalityperiprosthetic joint infectionhealth economy

Outcome Measures

Primary Outcomes (1)

  • Dislocation

    Dislocation will be ascertained by identifying the occurrence of any closed or open reduction of the previously inserted THA (the "index joint") within one year after surgery.

    1 year after index surgery

Secondary Outcomes (6)

  • Any re-operation of the index THA

    1 year after index surgery

  • Periprosthetic joint infection

    1 year after index surgery

  • Patient-reported outcome

    1 year after index surgery

  • Short-term mortality

    90 days after index surgery

  • Medium-term mortality

    365 days after index surgery

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Insertion of dual mobility cup

Device: Dual mobility cup

Control

ACTIVE COMPARATOR

Insertion of standard cup

Device: Standard cup

Interventions

Dual mobility cupDEVICE

Patients with a displaced femoral neck fracture eligible for THA receive a dual mobility cup, as opposed to a standard cup in the control group.

Intervention
Standard cupDEVICE

Patients with a displaced femoral neck fracture eligible for THA receive a standard cup, as opposed to a dual mobility cup in the experimental group.

Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Written informed consent
  • Diagnosis: displaced femoral neck fracture type AO 31-B2 or B3/Garden type 3 or 4
  • Eligible for THA according to local guidelines and routines

You may not qualify if:

  • Delayed fracture surgery (date of injury \>7 days prior to date of randomization)
  • Pathological or stress fracture of the femoral neck, or fracture adjacent to a previous ipsilateral hip implant
  • Inability or unwillingness to give written consent
  • Dementia (as diagnosed by the screening physician)
  • Unavailability of both interventions for a study subject (e.g., implants being out of stock, or lack of the individual surgeon's expertise to perform either procedure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nils Hailer

Uppsala, 75185, Sweden

Location

Queen Mary University of London

London, United Kingdom

Location

Related Publications (1)

  • Wolf O, Mukka S, Notini M, Moller M, Hailer NP; DUALITY GROUP. Study protocol: The DUALITY trial-a register-based, randomized controlled trial to investigate dual mobility cups in hip fracture patients. Acta Orthop. 2020 Oct;91(5):506-513. doi: 10.1080/17453674.2020.1780059. Epub 2020 Jun 22.

    PMID: 32567472DERIVED

MeSH Terms

Conditions

Femoral Neck FracturesJoint Dislocations

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Stergios Lazarinis, MD, PhD

    Uppsala University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 10, 2019

Study Start

January 17, 2020

Primary Completion

September 24, 2025

Study Completion

September 24, 2025

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)SE(1)