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

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.

Study Overview

• Status: Completed
• Conditions: Hip Dislocation
• Intervention / Treatment: Device: Hipstop 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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Holstebro, Denmark, 7500
    • Holstebro Regional Hospital
  • Viborg, Denmark, 8800
    • Viborg Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention; HipStop bandage for 12 weeks to prevent dislocation of the hip	Device: Hipstop bandage; 12 weeks use of a bandage to prevent hip dislocations in patients with previous dislocations
No Intervention: control; normal procedure after dislocation of hip which is information on movement restrictions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of dislocations	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip function	Oxford Hip Score, scores running from 0 to 48 with 48 being the best outcome	12 weeks
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
Patient satisfaction	questions to patients	12 weeks
Safety, wear and durability of bandage	Questionnaire to physiotherapists	12 weeks

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Maiken Stilling, PhD, University of Aarhus

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Hip Dislocation; Joint Dislocations
• Other Study ID Numbers: HipStop