Post-surgical Hematoma, Hip Replacement , SurgeryNCT05196321
Effects of Treatment With ENF (Electro Neuro Feedback) in the Reduction of Post-surgical Hematoma in Patients Undergoing Hip Replacement: Evaluation With Ultrasound Method
An observational study of Post-surgical Hematoma, Hip Replacement , Surgery, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The study evaluates patients with clinical evidence of post-surgical hematoma / seroma after hip replacement surgery. These patients will undergo ultrasound evaluation in the 4th (+/- 2) day post surgery, in which triaxial parameters of the hematoma will be measured. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Post-surgical Hematoma, Hip Replacement , Surgery
- What is being tested?
- sessions with ENF (Electro Neuro Feedback).
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 11 Nov 2021to 20 Jul 2023
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population is made up of patients who have undergone hip prosthesis surgery with the presence of post-surgical hematoma who are included in the hospital rehabilitation program lasting at least 5 days following this intervention.
Who may be able to join
- Gender: male and female
- Age: 35-85 years include
- Entry into the hospital rehabilitation program lasting at least 5 days following hip replacement surgery
- Absence in history of neurological or psychiatric disorders.
- Signature of the Informed Consent and consent to collaborate in all the procedures of the study
Who cannot join
- Presence of severe neurological / psychiatric pathologies
- to sign the Informed Consense
- of serious cardiological pathologies that can compromise patient safety
- of Pace Maker or spinal cord stimulators or other subcutaneous electronic instruments
- of active tumors in the treatment area
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Galeazzi -San Siro
Milan, 20161
About this study
The study evaluates patients with clinical evidence of post-surgical hematoma / seroma after hip replacement surgery. These patients will undergo ultrasound evaluation in the 4th (+/- 2) day post surgery, in which triaxial parameters of the hematoma will be measured. This evaluation will then be repeated after 5 treatment sessions with ENF (Electro Neuro Feedback). The patient will then be subjected to evaluation scales that allow to evaluate the subjective improvement of the state of well-being after treatment ENF (Electro Neuro Feedback) generates waveforms that change automatically when the impedance of the skin changes according to a compensation algorithm, i.e. according to Feedback (Feedback). T
- Being tested
- sessions with ENF (Electro Neuro Feedback).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sessions with ENF (Electro Neuro Feedback).Other
The study evaluates patients with clinical evidence of post-surgical hematoma / seroma after hip replacement surgery. These patients will undergo ultrasound evaluation in the 4th (+/- 2) day post surgery, in which triaxial parameters of the hematoma will be measured. This evaluation will then be repeated after 5 treatment sessions with ENF (Electro Neuro Feedback).
What is being measured
The primary outcome is the main question the study is designed to answer.
change of post-surgical hematoma measured by ultrasound method with triaxial measurement after 5 treatment sessions with ENF
Measured: at the end of Cycle 5 ( every cycle during 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start11 Nov 2021
- Primary completion18 Nov 2021
- Study completion20 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-surgical Hematoma, Hip Replacement , SurgeryStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- cristina beretta, Principal investigator, IRCCS istituto ortopedico galeazzi -sede san siro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196321
- Sponsor's protocol ID
- ENF PTA
- Status last verified
- Nov 2021
- First submitted
- 25 Nov 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treatment With ENF (Electro Neuro Feedback) in the Reduction of Post-surgical Hematoma in Patients Undergoing Hip Replacement: Evaluation With Ultrasound Method
- ClinicalTrials.gov ID
- NCT05196321
- Acronym / sponsor ID
- ENF PTA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 20 Jul 2023 (estimated)
- First posted
- 19 Jan 2022 (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.
The study evaluates patients with clinical evidence of post-surgical hematoma / seroma after hip replacement surgery. These patients will undergo ultrasound evaluation in the 4th (+/- 2) day post surgery, in which triaxial parameters of the hematoma will be measured. This evaluation will then be repeated after 5 treatment sessions with ENF (Electro Neuro Feedback). The patient will then be subjected to evaluation scales that allow to evaluate the subjective improvement of the state of well-being after treatment ENF (Electro Neuro Feedback) generates waveforms that change automatically when the impedance of the skin changes according to a compensation algorithm, i.e. according to Feedback (Feedback). T
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population is made up of patients who have undergone hip prosthesis surgery with the presence of post-surgical hematoma who are included in the hospital rehabilitation program lasting at least 5 days following this intervention.
Key inclusion criteria (5 listed)
- Gender: male and female
- Age: 35-85 years include
- Entry into the hospital rehabilitation program lasting at least 5 days following hip replacement surgery
- Absence in history of neurological or psychiatric disorders.
- Signature of the Informed Consent and consent to collaborate in all the procedures of the study
Key exclusion criteria (5 listed)
- Presence of severe neurological / psychiatric pathologies
- to sign the Informed Consense
- of serious cardiological pathologies that can compromise patient safety
- of Pace Maker or spinal cord stimulators or other subcutaneous electronic instruments
- of active tumors in the treatment area
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 |
|---|---|---|
| sessions with ENF (Electro Neuro Feedback).The study evaluates patients with clinical evidence of post-surgical hematoma / seroma after hip replacement surgery. These patients will undergo ultrasound evaluation in the 4th (+/- 2) day post surgery, in which triaxial parameters of the hematoma will be measured. This evaluation will then be repeated after 5 treatment sessions with ENF (Electro Neuro Feedback). | Other | – |
Primary outcome
change of post-surgical hematoma measured by ultrasound method with triaxial measurement after 5 treatment sessions with ENF
Time frame: at the end of Cycle 5 ( every cycle during 5 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
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.
cristina beretta principal investigator
IRCCS istituto ortopedico galeazzi -sede san siro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-surgical Hematoma, Hip Replacement , Surgery, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact cristina beretta (0039024878521, cristina.beretta@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of post-surgical hematoma measured by ultrasound method with triaxial measurement after 5 treatment sessions with ENF (time frame: at the end of Cycle 5 ( every cycle during 5 days)). 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 19 Jan 2022.