Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-04-16 @ 6:45 AM
Study NCT ID:
NCT06639334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Q-REDUCE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006617', 'term': 'Hip Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-01', 'size': 412605, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-01T12:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-10-10', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from arrival at the emergency entrance to prosthesis reduction', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Total hospitalization time from arrival to discharge', 'timeFrame': '1 year'}, {'measure': 'Intra-operative complications (fracture, unsuccessful reduction, aspiration, need for mask ventilation and/or intubation, others)', 'timeFrame': '1 year'}, {'measure': 'Post-operative complications (cardiac, pulmonal, thrombo-embolic events, nerve damage, re-dislocation, others) during hospitalization', 'timeFrame': '1 year'}, {'measure': '30 days re-admission', 'timeFrame': '30 days'}, {'measure': '30- and 90-days mortality', 'timeFrame': '30 and 90 days'}, {'measure': 'Hip-related pain measured by a 10-digit numeric rating scale (NRS)', 'timeFrame': 'Day 0, 1, 3, 7, 14 and 30', 'description': 'Evaluated from 1 (best) to 10 (worst).'}, {'measure': 'Patient-reported outcome (PRO) using the Hip disability and Osteoarthritis Outcome Score (HOOS),', 'timeFrame': 'Day 0, 14, 90, 180 and 365', 'description': 'Evaluated from 0 (worst) to 100 (best).'}, {'measure': 'Health-related quality of life using the EQ-5D questionnaire', 'timeFrame': 'Day 0, 14, 90, 180 and 365'}, {'measure': 'Patient satisfaction', 'timeFrame': 'During hospital admission, day 1.', 'description': 'Consists of four self-developed questions.'}, {'measure': 'Time consumption by the involved staff (orthopedic, anesthetic, radiology staff etc.)', 'timeFrame': '1 year'}, {'measure': 'Total hospital costs during admission', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['THA', 'Dislocation, Hip', 'PROM']}, 'referencesModule': {'references': [{'pmid': '40623887', 'type': 'DERIVED', 'citation': 'Eggers Rasmussen L, Forberg Almas T, Kuhne-Qvist PJ, Beese Dalby R, Biesenbach P, Lykke Hermansen L. Quick pathway for patients with high pRobability of dislocatEd hemiarthroplasty or total hip arthroplasty to minimise the time from hospital aDmission to redUCtion of the prosthesis (Q-REDUCE): protocol for a prospective cohort study. BMJ Open. 2025 Jul 7;15(7):e091791. doi: 10.1136/bmjopen-2024-091791.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to design a fast-track pathway for patients referred to the University Hospital of Southern Denmark, Esbjerg, with high probability of having a dislocated hip prosthesis with the primary aim to reduce the time from arrival to reduction and the total hospitalization time. Secondary aims are to\n\n* investigate whether quicker prosthesis reduction influences on hip function and quality of life afterwards\n* reduce the pain experience immediately and in the long term\n* increase patient satisfaction\n\nwithout changing the overall complication rate and readmission/mortality'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a history of either a THA or a HA in combination with at least one of the following terms\n* having sustained a sudden, incorrect movement or twist in the hip joint in either a bending, sitting or supine position leading to inability to stand or walk\n* misalignment of the concerned lower extremity (typically shortened, with inward/outward rotation)\n\nExclusion Criteria:\n\n* recurrent dislocations during the same hospital admission (already "in the house")\n* anticipated difficult airway by the attending anesthesiologist\n* anticipated need for extended respiratory or hemodynamic monitoring by the attending anesthesiologist\n* American Society of Anesthesiologists (ASA) score \\> 3\n* Body Mass Index (BMI) \\> 40\n* active drug abuse\n* contraindication for Propofol or Esketamine'}, 'identificationModule': {'nctId': 'NCT06639334', 'briefTitle': 'The Q-REDUCE Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'A Quick Pathway for Patients With High pRobability of dislocatEd Hemi- or Total Hip Arthroplasty to Minimize the Time From Hospital aDmission to redUCtion of the prosthEsis', 'orgStudyIdInfo': {'id': '24/34681'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment', 'description': 'Standard pathway for THA/HE reduction', 'interventionNames': ['Other: Standard pathway for THA/HE prosthesis reduction']}, {'type': 'EXPERIMENTAL', 'label': 'Fast-track treatment', 'description': 'Fasttrack pathway for THA/HE reduction', 'interventionNames': ['Other: Fasttrack pathway for THA/HE prosthesis reduction']}], 'interventions': [{'name': 'Fasttrack pathway for THA/HE prosthesis reduction', 'type': 'OTHER', 'description': 'The purpose of this study is to design a fast-track pathway for patients referred to the University Hospital of Southern Denmark, Esbjerg, with high probability of having a dislocated hip prosthesis with the primary aim to reduce the time from arrival to reduction and the total hospitalization time.\n\nThe intervention is changed logistic and work pathways at the hospital that should reduce time to reduction significantly. For detailed description we refer to the uploaded protocol.', 'armGroupLabels': ['Fast-track treatment']}, {'name': 'Standard pathway for THA/HE prosthesis reduction', 'type': 'OTHER', 'description': 'Standard treatment for a dislocated THA/HA at our institution is education in general anesthesia at the operating theater. For detailed description we refer to the uploaded protocol.', 'armGroupLabels': ['Standard treatment']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of Southern Denmark', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Lars Lykke Hermansen', 'investigatorAffiliation': 'University of Southern Denmark'}}}}