NCT05012969

Brief Summary

This trial investigates the effectiveness of using a bandage after dislocation of the hip after total hip arthroplasty. Patients with a dislocated hip after total hip arthroplasty coming to the emergency department to have the hip relocated will be asked to participate in the trial. The patients will be randomised to either a bandage that reduces flexion, adduction and internal rotation of the hip or no bandage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

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

Study Start

First participant enrolled

November 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
5.8 years until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

6.1 years

First QC Date

November 19, 2015

Last Update Submit

December 7, 2022

Conditions

Hip Dislocation

Outcome Measures

Primary Outcomes (1)

  • number of dislocations

    12 weeks

Secondary Outcomes (4)

  • Hip function

    12 weeks

  • Helat-related quality of life

    12 weeks

  • Patient satisfaction

    12 weeks

  • Safety, wear and durability of bandage

    12 weeks

Study Arms (2)

intervention

EXPERIMENTAL

HipStop bandage for 12 weeks to prevent dislocation of the hip

Device: Hipstop bandage

control

NO INTERVENTION

normal procedure after dislocation of hip which is information on movement restrictions

Interventions

Hipstop bandageDEVICE

12 weeks use of a bandage to prevent hip dislocations in patients with previous dislocations

intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has had at least one previous hip dislocation after total hip arthroplasty

You may not qualify if:

  • Dislocation in other directions than posterior/superior
  • Loose prosthesis
  • wounds in the area of skin that is in contact with the bandage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Holstebro Regional Hospital

Holstebro, 7500, Denmark

Location

Viborg Regional Hospital

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip Injuries

Study Officials

  • Inger Mechlenburg, PhD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

  • Maiken Stilling, PhD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 19, 2015

First Posted

August 19, 2021

Study Start

November 1, 2015

Primary Completion

December 1, 2021

Study Completion

August 31, 2022

Last Updated

December 8, 2022

Record last verified: 2022-12

Locations

DK(2)