Investigation of Efficacy of Use of a Bandage

Not Applicable

Completed

• Conditions: Hip Dislocation
• Interventions: Device: Hipstop bandage

• Registration Number: NCT05012969
• Lead Sponsor: University of Aarhus

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:

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

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-19
• Primary Completion: 2021-12
• Study Completion: 2022-08-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Hipstop bandage	HipStop bandage for 12 weeks to prevent dislocation of the hip

Primary Outcome Measures

Name	Time	Method
number of dislocations	12 weeks

Secondary Outcome Measures

Name	Time	Method
Hip function	12 weeks	Oxford Hip Score, scores running from 0 to 48 with 48 being the best outcome
Safety, wear and durability of bandage	12 weeks	Questionnaire to physiotherapists
Helat-related quality of life	12 weeks	SF-36, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability
Patient satisfaction	12 weeks	questions to patients

Trial Locations

Locations (2)

Holstebro Regional Hospital; 🇩🇰 Holstebro, Denmark

Viborg Regional Hospital; 🇩🇰 Viborg, Denmark