Investigation of Efficacy of Use of a Bandage to Prevent Hip Dislocation After Total Hip Arthroplasty in Patients With Previous Dislocation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- number of dislocations
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
number of dislocations
Time Frame: 12 weeks
Secondary Outcomes
- Hip function(12 weeks)
- Safety, wear and durability of bandage(12 weeks)
- Helat-related quality of life(12 weeks)
- Patient satisfaction(12 weeks)