Investigation of Efficacy of Use of a Bandage | NCT05012969

Studies
Investigation of Efficacy of Use of a Bandage

NCT05012969

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Dec 8, 2022Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Hip Dislocation

Interventions

Hipstop bandage

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Dec 2021Actual

Completion Date

Aug 31, 2022Actual

First Submitted Date

Nov 19, 2015

First Submission Date that Met QC Criteria

Aug 12, 2021

First Posted Date

Aug 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2022

Last Update Posted Date

Dec 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This trial investigates the effectiveness of using a bandage after dislocation of the hip after total hip arthroplasty.

Detailed Description

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:

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Hipstop bandage	Device	12 weeks use of a bandage to prevent hip dislocations in patients with previous dislocations	intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of dislocations		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Hip function	Oxford Hip Score, scores running from 0 to 48 with 48 being the best outcome	12 weeks
Helat-related quality of life	SF-36, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Inger Mechlenburg, PhD	University of Aarhus	Principal Investigator
Maiken Stilling, PhD	University of Aarhus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Holstebro Regional Hospital		Holstebro		7500	Denmark
Viborg Regional Hospital

Condition Browse Module

MeSH Terms

ID	Term
D006617	Hip Dislocation

Ancestor Terms

ID	Term
D004204	Joint Dislocations
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided