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Investigation of Efficacy of Use of a Bandage

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05012969
Enrollment
100
Registered
2021-08-19
Start date
2015-11-30
Completion date
2022-08-31
Last updated
2022-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Dislocation

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

Interventions

DEVICEHipstop bandage

12 weeks use of a bandage to prevent hip dislocations in patients with previous dislocations

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
number of dislocations12 weeks

Secondary

MeasureTime frameDescription
Hip function12 weeksOxford Hip Score, scores running from 0 to 48 with 48 being the best outcome
Helat-related quality of life12 weeksSF-36, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability
Patient satisfaction12 weeksquestions to patients
Safety, wear and durability of bandage12 weeksQuestionnaire to physiotherapists

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026