Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-01 @ 11:57 PM
Study NCT ID:
NCT05012969
Status:
COMPLETED
Last Update Posted:
2022-12-08
First Post:
2015-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Efficacy of Use of a Bandage
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
Investigation of Efficacy of Use of a Bandage to Prevent Hip Dislocation After Total Hip Arthroplasty in Patients With Previous Dislocation
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: