Transient Arthropathy of HipNCT02163200
Changes of Pressure on Soft Tissue Before and After Total Hip Replacement to Prevent Bedsores
An observational study of Transient Arthropathy of Hip, run by Assuta Medical Center.
Trial summary
Patients candidates for total hip replacement are, generally elderlies and have hip pain, we will check if the pressure to the soft tissue changes before and after operation using a tapet with pressure sensors sending the information to specific software. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Transient Arthropathy of Hip
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Oct 2014
- How long will I take part?
- 4 Months
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient 60 y.o. or more both sexs, schedule for total hip replacement, without previous bedsore
Who may be able to join
- Both sexes
- Schedule for total hip replacement
Who cannot join
- Patient with previous bedsore
- Patients under 60 y.0.
- Previous CVA
About this study
Patients candidates for total hip replacement are, generally elderlies and have hip pain, we will check if the pressure to the soft tissue changes before and after operation using a tapet with pressure sensors sending the information to specific software.
Read the detailed description
one hundred Patients 60 years old and more will be considered for this study, both sexs, that have schedule for elective unilateral total hip replacement and have not bedsores previously.
All the data will be collected by FSA software, classified in an excel table. A crossover study will be performed and analyzed by a paired test.
- Conditions
- Transient Arthropathy of Hip
- Keywords
- Bedsores, pressure, hip
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pressure of total hip replacement | Patients 60 y.o. or more both sex with a history of hip arthropathy without previous bedsores or CVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in soft tissue pressure
Mapping of pressure will be performed twice for each patient' the first one before surgery the second one before discharge. The measure will be performed by resting, normal position
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Why it stopped: due to technical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Arthropathy of HipStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Gabriel Susmallian, Assuta Medical Center
- Investigators
- Sergio G Susmallian, MD, Study director, Assuta MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163200
- Sponsor's protocol ID
- 0906-14
- Status last verified
- Mar 2016
- First submitted
- 9 Jun 2014
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Pressure on Soft Tissue Before and After Total Hip Replacement to Prevent Bedsores
- ClinicalTrials.gov ID
- NCT02163200
- Acronym / sponsor ID
- 0906-14
- Conditions
- Transient Arthropathy of Hip
- Keywords
- Bedsores, pressure, hip
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: due to technical issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 13 Jun 2014 (estimated)
- 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.
Patients candidates for total hip replacement are, generally elderlies and have hip pain, we will check if the pressure to the soft tissue changes before and after operation using a tapet with pressure sensors sending the information to specific software.
Detailed description
one hundred Patients 60 years old and more will be considered for this study, both sexs, that have schedule for elective unilateral total hip replacement and have not bedsores previously.
All the data will be collected by FSA software, classified in an excel table. A crossover study will be performed and analyzed by a paired test.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pressure of total hip replacement | – | –Patients 60 y.o. or more both sex with a history of hip arthropathy without previous bedsores or CVA |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient 60 y.o. or more both sexs, schedule for total hip replacement, without previous bedsore
Key inclusion criteria (2 listed)
- Both sexes
- Schedule for total hip replacement
Key exclusion criteria (3 listed)
- Patient with previous bedsore
- Patients under 60 y.0.
- Previous CVA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in soft tissue pressure
Time frame: Day one
Mapping of pressure will be performed twice for each patient' the first one before surgery the second one before discharge. The measure will be performed by resting, normal position
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
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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.
Sergio G Susmallian, MD study director
Assuta MC
Questions about this trial
What is this clinical trial studying?
An observational study of Transient Arthropathy of Hip, run by Assuta Medical Center.
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 2 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: withdrawn, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in soft tissue pressure (time frame: Day one). 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 29 Mar 2016.