Investigation of Efficacy of Use of a Bandage

Hip Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05012969
• Other study ID #: HipStop
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: August 31, 2022

Study information

• Verified date: December 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 31, 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Dislocation

Intervention

Device:
• Hipstop bandage
12 weeks use of a bandage to prevent hip dislocations in patients with previous dislocations

Locations

Country	Name	City	State
Denmark	Holstebro Regional Hospital	Holstebro
Denmark	Viborg Regional Hospital	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of dislocations		12 weeks
Secondary	Hip function	Oxford Hip Score, scores running from 0 to 48 with 48 being the best outcome	12 weeks
Secondary	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
Secondary	Patient satisfaction	questions to patients	12 weeks
Secondary	Safety, wear and durability of bandage	Questionnaire to physiotherapists	12 weeks