Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-06 @ 11:34 AM
Study NCT ID:
NCT07276061
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outpatient Total Knee Arthroscopy (TKA): Comparison of Postoperative Recovery Versus a Conventional Hospitalization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QoR-15F score', 'timeFrame': 'at Day 1,Day 3, Day 14 and Day 28 post-operative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee arthroscopy'], 'conditions': ['Knee Arthroscopy']}, 'descriptionModule': {'briefSummary': 'Outpatient TKA is a controversial topic due to concerns about its safety as an outpatient procedure, and remains a marginal procedure. Advances in enhanced postoperative rehabilitation protocols, coupled with advances in minimally invasive surgery, have made it possible to operate on an increasing number of patients on an outpatient basis. However, there are no studies in the literature analyzing functional recovery after outpatient TKA in France. The objective of this study was to compare postoperative recovery, assessed by the QoR-15F score, in patients undergoing outpatient TKA compared to those undergoing a conventional hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female, 18 years of age or older (no upper age limit) undergoing scheduled unilateral total knee replacement surgery between January 1, 2020 and June 30, 2023 at the Strasbourg University Hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 18 years of age or older (no upper age limit)\n* Undergoing scheduled unilateral total knee replacement surgery between January 1, 2020 and June 30, 2023 at the Strasbourg University Hospitals\n* Assessed using the QoR-15F score\n\nExclusion Criteria:\n\n* Subject who has expressed opposition to the reuse of their data for scientific research purposes.\n* Revision, emergency, oncological, bilateral, or septic surgery.'}, 'identificationModule': {'nctId': 'NCT07276061', 'acronym': 'PTG', 'briefTitle': 'Outpatient Total Knee Arthroscopy (TKA): Comparison of Postoperative Recovery Versus a Conventional Hospitalization', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Outpatient Total Knee Prosthesis, Comparison of Postoperative Recovery Versus Conventional Hospitalization: a Retrospective, Single-center, Observational, Comparative Study of Superiority', 'orgStudyIdInfo': {'id': '9240'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric NOLL, MD, PhD', 'role': 'CONTACT', 'email': 'eric.noll@chru-strasbourg.fr', 'phone': '33 3 88 12 70 76'}, {'name': 'Eric NOLL, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Julie GU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jullien POTTECHER, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'François BONNOMET, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'François LEFEBVRE, Statician', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service d'Anesthésie - Réanimation & Médecine Périopératoire - CHU de Strasbourg - France", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Eric NOLL, MD, PhD', 'role': 'CONTACT', 'email': 'eric.noll@chru-strasbourg.fr', 'phone': '33 3 88 12 70 76'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}