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Completed

NCT Number: NCT05012969

Investigation of Efficacy of Use of a Bandage

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.

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Key information

Conditions

Hip Dislocation Hip Injuries Joint Diseases Joint Dislocations Musculoskeletal Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holstebro Regional Hospital, Holstebro, Denmark

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hipstop bandage

Device

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

Primary outcomes

  1. number of dislocations

    Time frame: 12 weeks

Secondary outcomes

  1. Hip function

    Time frame: 12 weeks

    Oxford Hip Score, scores running from 0 to 48 with 48 being the best outcome

  2. Helat-related quality of life

    Time frame: 12 weeks

    SF-36, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability

  3. Patient satisfaction

    Time frame: 12 weeks

    questions to patients

  4. Safety, wear and durability of bandage

    Time frame: 12 weeks

    Questionnaire to physiotherapists

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Aug 19, 2021
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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