Investigation of Efficacy of Use of a Bandage

NCT ID: NCT05012969

Last Updated: 2022-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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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. Patients in the intervention group will use the bandage for 12 weeks and patients in the control group will receive the normal treatment which is information by a physiotherapist on movement restrictions.

50 patients will be allocated in the intervention group and 50 patients will be allocated to the control group.

We will investigate:

1. Whether there is a difference in number of dislocations between the two groups in the project period (12 weeks).
2. Patients' hip function, quality of life and satisfaction with the treatment in the two groups
3. The safety, wear and durability of the bandage after 12 weeks of use

Conditions

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Hip Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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intervention

HipStop bandage for 12 weeks to prevent dislocation of the hip

Group Type EXPERIMENTAL

Hipstop bandage

Intervention Type DEVICE

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

control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hipstop bandage

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Inger Mechlenburg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Maiken Stilling, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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Holstebro Regional Hospital

Holstebro, , Denmark

Site Status

Viborg Regional Hospital

Viborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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HipStop

Identifier Type: -

Identifier Source: org_study_id

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