Investigation of Efficacy of Use of a Bandage
Primary Purpose
Hip Dislocation
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Hipstop bandage
Sponsored by
About this trial
This is an interventional prevention trial for Hip Dislocation
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
Sites / Locations
- Holstebro Regional Hospital
- Viborg Regional Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention
control
Arm Description
HipStop bandage for 12 weeks to prevent dislocation of the hip
normal procedure after dislocation of hip which is information on movement restrictions
Outcomes
Primary Outcome Measures
number of dislocations
Secondary Outcome Measures
Hip function
Oxford Hip Score, scores running from 0 to 48 with 48 being the best outcome
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
Patient satisfaction
questions to patients
Safety, wear and durability of bandage
Questionnaire to physiotherapists
Full Information
NCT ID
NCT05012969
First Posted
November 19, 2015
Last Updated
December 7, 2022
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT05012969
Brief Title
Investigation of Efficacy of Use of a Bandage
Official Title
Investigation of Efficacy of Use of a Bandage to Prevent Hip Dislocation After Total Hip Arthroplasty in Patients With Previous Dislocation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
August 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Dislocation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
HipStop bandage for 12 weeks to prevent dislocation of the hip
Arm Title
control
Arm Type
No Intervention
Arm Description
normal procedure after dislocation of hip which is information on movement restrictions
Intervention Type
Device
Intervention Name(s)
Hipstop bandage
Intervention Description
12 weeks use of a bandage to prevent hip dislocations in patients with previous dislocations
Primary Outcome Measure Information:
Title
number of dislocations
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Hip function
Description
Oxford Hip Score, scores running from 0 to 48 with 48 being the best outcome
Time Frame
12 weeks
Title
Helat-related quality of life
Description
SF-36, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability
Time Frame
12 weeks
Title
Patient satisfaction
Description
questions to patients
Time Frame
12 weeks
Title
Safety, wear and durability of bandage
Description
Questionnaire to physiotherapists
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inger Mechlenburg, PhD
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maiken Stilling, PhD
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holstebro Regional Hospital
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
Facility Name
Viborg Regional Hospital
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
12. IPD Sharing Statement
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Investigation of Efficacy of Use of a Bandage
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