Investigation of Efficacy of Use of a Bandage

Study Overview
=================
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

Official Title
-----------------
Investigation of Efficacy of Use of a Bandage to Prevent Hip Dislocation After Total Hip Arthroplasty in Patients With Previous Dislocation

Conditions
-----------------
Hip Dislocation

Intervention / Treatment
-----------------
* Device: Hipstop bandage


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>HipStop bandage for 12 weeks to prevent dislocation of the hip | Device: Hipstop bandage<br>* 12 weeks use of a bandage to prevent hip dislocations in patients with previous dislocations<br>|
| No Intervention: control<br>normal procedure after dislocation of hip which is information on movement restrictions | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of dislocations |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 12 weeks | 
| Patient satisfaction | questions to patients | 12 weeks | 
| Safety, wear and durability of bandage | Questionnaire to physiotherapists | 12 weeks |