Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT06308003
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Surgical Approach on Postoperative Bleeding in Patien Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2024-03-06', 'studyFirstSubmitQcDate': '2024-03-06', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.', 'timeFrame': 'the third postoperative day', 'description': 'The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Arthropathy']}, 'descriptionModule': {'briefSummary': 'The study is, in accordance with current legislation, definable as monocentric Prospective Observational.\n\nThe primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.\n\nadult patients who will undergo surgery of hip arthroplasty.\n\nPatients will undergo:\n\nPreoperative 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.', 'detailedDescription': "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.\n\nIt 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.\n\nThe primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.\n\nSecondary 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.\n\nAdult patients who will undergo surgery of hip arthroplasty.\n\nThe inclusion criteria are:\n\n* adult patients with coxarthrosis who are candidates for surgery hip arthroplasty\n* Signing of the Informed Consent and consent to collaborate in all study procedures.\n\nThe exclusion criteria are:\n\n* Minors\n* Pregnant women (self-declaration)\n* patients with BMI ≥ 30\n* Non-acceptance of informed consent\n* Patients with prior unilateral hip reconstructive surgery or Contralateral"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients who will undergo surgery of hip arthroplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients with coxarthrosis who are candidates for surgery hip arthroplasty\n* Signing of the Informed Consent and consent to collaborate in all study procedures.\n\nExclusion Criteria:\n\n* Minors\n* Pregnant women (self-declaration)\n* patients with BMI ≥ 30\n* Non-acceptance of informed consent\n* Patients with prior unilateral hip reconstructive surgery or Contralateral'}, 'identificationModule': {'nctId': 'NCT06308003', 'briefTitle': 'Effect of Surgical Approach on Postoperative Bleeding in Patien Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, 'officialTitle': 'Effect of Surgical Approach on Postoperative Bleeding in Patients Undergoing Hip Arthroplasty: Anterior Vs. Posterolateral Route', 'orgStudyIdInfo': {'id': 'PTA CONF'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Anterior hip arthroplasty', 'type': 'PROCEDURE', 'description': 'Anterior hip arthroplasty'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elena Cittera', 'role': 'CONTACT', 'email': 'elena.cittera@grupposandonato.it', 'phone': '0283502224'}, {'name': 'Alberto Ventura', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Clinico San Siro', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Elena Cittera', 'role': 'CONTACT', 'email': 'elena.cittera@grupposandonato.it', 'phone': '0283502224'}], 'overallOfficials': [{'name': 'Alberto Ventura', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ospedale Galeazzi-Sant'Ambrogio"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}