Hip DislocationNCT05012969
Investigation of Efficacy of Use of a Bandage
A study testing Hipstop bandage in people with Hip Dislocation, run by University of Aarhus at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Dislocation
- What is being tested?
- Hipstop bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2015to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has had at least one previous hip dislocation after total hip arthroplasty
Who cannot join
- Dislocation in other directions than posterior/superior
- Loose prosthesis
- wounds in the area of skin that is in contact with the bandage
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Holstebro Regional Hospital
Holstebro, 7500
Viborg Regional Hospital
Viborg, 8800
About this study
Official title: 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.
Read the 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
- Conditions
- Hip Dislocation
- Being tested
- Hipstop bandage
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hipstop bandageDevice
12 weeks use of a bandage to prevent hip dislocations in patients with previous dislocations
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | HipStop bandage for 12 weeks to prevent dislocation of the hip Receives: Device: Hipstop bandage |
| control | No intervention | normal procedure after dislocation of hip which is information on movement restrictions |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of dislocations
Measured: 12 weeks
Secondary outcomes (4)
Hip function
Oxford Hip Score, scores running from 0 to 48 with 48 being the best outcome
Measured: 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
Measured: 12 weeks
Patient satisfaction
questions to patients
Measured: 12 weeks
Safety, wear and durability of bandage
Questionnaire to physiotherapists
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study startNov 2015
- Primary completionDec 2021
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DislocationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inger Mechlenburg, PhD, Principal investigator, University of AarhusMaiken Stilling, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012969
- Sponsor's protocol ID
- HipStop
- Status last verified
- Dec 2022
- First submitted
- 19 Nov 2015
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Efficacy of Use of a Bandage to Prevent Hip Dislocation After Total Hip Arthroplasty in Patients With Previous Dislocation
- ClinicalTrials.gov ID
- NCT05012969
- Acronym / sponsor ID
- HipStop
- Conditions
- Hip Dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2021 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: Hipstop bandageHipStop bandage for 12 weeks to prevent dislocation of the hip |
| control | No intervention | –normal procedure after dislocation of hip which is information on movement restrictions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Has had at least one previous hip dislocation after total hip arthroplasty
Key exclusion criteria (3 listed)
- Dislocation in other directions than posterior/superior
- Loose prosthesis
- wounds in the area of skin that is in contact with the bandage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hipstop bandage12 weeks use of a bandage to prevent hip dislocations in patients with previous dislocations | Device | intervention |
Primary outcome
number of dislocations
Time frame: 12 weeks
4 secondary outcomes
Hip function
Time frame: 12 weeks
Helat-related quality of life
Time frame: 12 weeks
Patient satisfaction
Time frame: 12 weeks
Safety, wear and durability of bandage
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inger Mechlenburg, PhD principal investigator
University of Aarhus
Maiken Stilling, PhD principal investigator
University of Aarhus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hipstop bandage in people with Hip Dislocation, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of dislocations (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.