Hip ArthropathyNCT06308003
Effect of Surgical Approach on Postoperative Bleeding in Patien Arthroplasty
An observational study of Hip Arthropathy, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The study is, in accordance with current legislation, definable as monocentric Prospective Observational. The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day. adult patients who will undergo surgery of hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthropathy
- What is being tested?
- Anterior hip arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 13 Feb 2023to Sep 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients who will undergo surgery of hip arthroplasty
Who may be able to join
- adult patients with coxarthrosis who are candidates for surgery hip arthroplasty
- Signing of the Informed Consent and consent to collaborate in all study procedures.
Who cannot join
- Minors
- Pregnant women (self-declaration)
- patients with BMI ≥ 30
- Non-acceptance of informed consent
- Patients with prior unilateral hip reconstructive surgery or Contralateral
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinico San Siro
Milan
Elena Cittera, 0283502224, elena.cittera@grupposandonato.it
Alberto Ventura
About this study
Official title: Effect of Surgical Approach on Postoperative Bleeding in Patients Undergoing Hip Arthroplasty: Anterior Vs. Posterolateral Route
The study is, in accordance with current legislation, definable as monocentric Prospective Observational.
The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.
Read more
adult patients who will undergo surgery of hip arthroplasty.
Patients will undergo:
Preoperative T0: clinical visit/medical history, completion of the VAS questionnaire, Blood sampling to assess hemoglobin values Operative T1: hip arthroplasty surgery using one of the surgical approaches routinely used within our Institute T2 - Postoperative at 1 day from T1: VAS questionnaire, evaluation of any Adverse events T3 - Postoperative at 3 days from T1: blood loss based on the values of hemoglobin (Hb), assessment of any adverse events, and VAS questionnaire T4- Post operative at 45 days +/- 10 days from T1: evaluation of any events adverse, follow-up visit.
Read the detailed description
The presence of bleeding and pain after prosthesis surgery Hip injuries can affect the patient's condition in the postoperative period increasing the length of hospital stay and slowing down the rehabilitation process.
It is hypothesized that there are differences in terms of postoperative bleeding, Postoperative pain and hospital stay time between different approaches surgical procedures in the treatment of hip osteoarthritis with arthroprosthesis. The adoption of a Surgical approach that can reduce bleeding and pain could reduce the length of hospital stay in patients undergoing hip arthroplasty.
The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.
Secondary objectives are postoperative pain assessment with questionnaire VAS and length of hospital stay according to surgical approach used (anterior Vs. posterolateral route). Also evaluate Any adverse events.
Adult patients who will undergo surgery of hip arthroplasty.
The inclusion criteria are:
- adult patients with coxarthrosis who are candidates for surgery hip arthroplasty
- Signing of the Informed Consent and consent to collaborate in all study procedures.
The exclusion criteria are:
- Minors
- Pregnant women (self-declaration)
- patients with BMI ≥ 30
- Non-acceptance of informed consent
- Patients with prior unilateral hip reconstructive surgery or Contralateral
- Conditions
- Hip Arthropathy
- Being tested
- Anterior hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior hip arthroplastyProcedure or surgery
Anterior hip arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.
The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.
Measured: the third postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start13 Feb 2023
- Primary completionApr 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthropathyStudies 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
- 50 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
- Alberto Ventura, Principal investigator, Ospedale Galeazzi-Sant'Ambrogio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308003
- Sponsor's protocol ID
- PTA CONF
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Surgical Approach on Postoperative Bleeding in Patients Undergoing Hip Arthroplasty: Anterior Vs. Posterolateral Route
- ClinicalTrials.gov ID
- NCT06308003
- Acronym / sponsor ID
- PTA CONF
- Conditions
- Hip Arthropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 13 Mar 2024 (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 is, in accordance with current legislation, definable as monocentric Prospective Observational.
The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.
adult patients who will undergo surgery of hip arthroplasty.
Patients will undergo:
Preoperative T0: clinical visit/medical history, completion of the VAS questionnaire, Blood sampling to assess hemoglobin values Operative T1: hip arthroplasty surgery using one of the surgical approaches routinely used within our Institute T2 - Postoperative at 1 day from T1: VAS questionnaire, evaluation of any Adverse events T3 - Postoperative at 3 days from T1: blood loss based on the values of hemoglobin (Hb), assessment of any adverse events, and VAS questionnaire T4- Post operative at 45 days +/- 10 days from T1: evaluation of any events adverse, follow-up visit.
Detailed description
The presence of bleeding and pain after prosthesis surgery Hip injuries can affect the patient's condition in the postoperative period increasing the length of hospital stay and slowing down the rehabilitation process.
It is hypothesized that there are differences in terms of postoperative bleeding, Postoperative pain and hospital stay time between different approaches surgical procedures in the treatment of hip osteoarthritis with arthroprosthesis. The adoption of a Surgical approach that can reduce bleeding and pain could reduce the length of hospital stay in patients undergoing hip arthroplasty.
The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.
Secondary objectives are postoperative pain assessment with questionnaire VAS and length of hospital stay according to surgical approach used (anterior Vs. posterolateral route). Also evaluate Any adverse events.
Adult patients who will undergo surgery of hip arthroplasty.
The inclusion criteria are:
- adult patients with coxarthrosis who are candidates for surgery hip arthroplasty
- Signing of the Informed Consent and consent to collaborate in all study procedures.
The exclusion criteria are:
- Minors
- Pregnant women (self-declaration)
- patients with BMI ≥ 30
- Non-acceptance of informed consent
- Patients with prior unilateral hip reconstructive surgery or Contralateral
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients who will undergo surgery of hip arthroplasty
Key inclusion criteria (2 listed)
- adult patients with coxarthrosis who are candidates for surgery hip arthroplasty
- Signing of the Informed Consent and consent to collaborate in all study procedures.
Key exclusion criteria (5 listed)
- Minors
- Pregnant women (self-declaration)
- patients with BMI ≥ 30
- Non-acceptance of informed consent
- Patients with prior unilateral hip reconstructive surgery or Contralateral
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 |
|---|---|---|
| Anterior hip arthroplastyAnterior hip arthroplasty | Procedure or surgery | – |
Primary outcome
The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.
Time frame: the third postoperative day
The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Hip Arthropathy
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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.
Alberto Ventura principal investigator
Ospedale Galeazzi-Sant'Ambrogio
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 Hip Arthropathy, 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 2 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 13 Mar 2024. 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 Elena Cittera (0283502224, elena.cittera@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day. (time frame: the third postoperative day). 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 13 Mar 2024.