Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT04903860
Status:
COMPLETED
Last Update Posted:
2022-07-28
First Post:
2021-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019644', 'term': 'Arthroplasty, Replacement, Hip'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-27', 'studyFirstSubmitDate': '2021-05-12', 'studyFirstSubmitQcDate': '2021-05-25', 'lastUpdatePostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall cost of surgery', 'timeFrame': 'At 3 months', 'description': 'Direct medical costing in both groups:\n\n* Sterilization costs,\n* Inventory management costs,\n* Material costs,\n* Waste management costs,\n* Operating room costs based on room occupancy times.'}], 'secondaryOutcomes': [{'measure': 'Surgical time', 'timeFrame': 'intraoperative', 'description': 'Calculated from the beginning of the skin incision to closure and recorded on the anesthesia sheet'}, {'measure': "Modified Merle d'Aubigné and Postel Method score", 'timeFrame': 'Pré-opérative examination / At 3 months', 'description': "The patients were evaluated by the Modified Merle d'Aubigné and Postel Method, which evaluates pain, gait and mobility, on a scale of 1 to 6 for each item, where 1 indicates the worst and 6, the best state of the patient. The total minimum score reached is 3, and the maximum is 18."}, {'measure': 'Harris Hip Score', 'timeFrame': 'Pré-opérative examination / At 3 months', 'description': 'This instrument has 10 items in 3 sections describing pain, function, range of motion, and deformity. The first section is questionnaire-based, answered by the patient, and includes impairments and activities. The second and third sections are administered by the therapist or physician, and include leg length measurement and range of motion (ROM) measures of the hip (flexion, abduction, external rotation and adduction). Each item has a unique numerical scale that corresponds to descriptive response options. The highest possible score is 100, with a higher score indicating less dysfunction.'}, {'measure': 'Charnley classification and Devane score', 'timeFrame': 'Pré-opérative examination / At 3 months', 'description': "Devane score: The purpose of this score is to specify the patient's activity level preoperatively. Initially established by Devane, it allows a classification of each patient in 5 categories from sedentary to athletic Charnley score: This is a commonly used score designed to assess the patient's overall disability in relation to gait function. It was published by Charnley and distinguishes patients into 3 categories"}, {'measure': 'WOMAC score', 'timeFrame': 'Pré-opérative examination / At 3 months', 'description': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of hip, including five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).'}, {'measure': 'HOOS score', 'timeFrame': 'Pré-opérative examination / At 3 months', 'description': "The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process. To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms."}, {'measure': 'Pain evaluation', 'timeFrame': 'Pré-opérative examination / At 3 months', 'description': 'The visual similar scale is auto completed. For the intensity of pain, the scale varies between "no pain" (the score of 0) and "most painful" (the score of 10).'}, {'measure': 'Operator satisfaction', 'timeFrame': 'through surgical intervention an average of 1 day', 'description': 'Operator satisfaction score (numerical scale from 0 (not satisfied) to 10 (very satisfied)) of the material during the surgical procedure'}, {'measure': 'Radiological analysis', 'timeFrame': 'At 3 months', 'description': 'realization of standard radiographs of the pelvis from the front, hip from the front and from the side. Analysis of the acetabulum according to Charnley and search for the presence of granulometry, migration or acetabular osteolysis. Measurement of the femoral and acetabular offset and height of the center of rotation'}, {'measure': 'Complications', 'timeFrame': 'At 3 months', 'description': 'Analysis of possible intraoperative and postoperative complications and their costs: loosening, infection, dislocation, wear and implant fracture'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prospective', 'Randomized study', 'Medico-economic', 'Sterilization', 'Single use reamer', 'Ancillary'], 'conditions': ['Total Hip Replacement', 'Coxarthrosis']}, 'referencesModule': {'references': [{'pmid': '37451339', 'type': 'DERIVED', 'citation': 'Erivan R, Bourzat N, Mulliez A, Mougues C, Descamps S, Boisgard S, Villatte G. Single-use versus reusable ancillaries for dual mobility cup in total hip replacement. A prospective randomized short-term safety and feasibility comparison. Orthop Traumatol Surg Res. 2023 Nov;109(7):103658. doi: 10.1016/j.otsr.2023.103658. Epub 2023 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to compare the use of single-use ancillary reaming material during total hip replacement and conventional reusable ancillary reaming material.\n\nThe assessment will focus on the medico-economic differences found in this prospective randomized study', 'detailedDescription': 'In orthopaedics, the ancillary equipment is a generic term that includes all the instruments necessary for hip replacement surgery. The surgeon remains very dependent on these boxes of instruments, including rasps, reamers and trial implants (stems and trial heads), which are required in THR. Each instrument set is generally packaged in 2 or 3 boxes and each surgeon has a limited number of instrument sets at his disposal per operating day. Each ancillary device has a purchase cost, a maintenance cost (paid by the laboratories or distributors) and a sterilization cost, (paid by the health care institutions).\n\nSingle-use reamers are instruments that are used on a single patient and then discarded. Performance and safety of use are optimized by providing a sterile and new product for each use.\n\nTherefore, it seems judicious to compare the medico-economic differences between the use of single-use reamers versus reusable reamers within a classic ancillary.\n\nThis study will compare the costs incurred, the waste produced, the operating time, the satisfaction of the surgeon after the use of single-use reamers during total hip replacement, versus conventional re-sterilizable ancillary and verify the equivalence, three months after surgery, of clinical and radiological results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Patient, male or female, over 18 years of age, eligible for a first-line total hip replacement for isolated coxarthrosis\n* Patient registered to the national health system\n* Patient able to understand information about the protocol and answer to questionnaire\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding or potentially pregnant woman\n* Major disability\n* History of hip replacement surgery\n* Any surgical and/or anesthetic contraindication, or any condition deemed by the investigator to be incompatible with the research.\n* Morbid obesity as defined by body mass index (BMI) \\>40 kg.m-2\n* History of recent infection at the surgical site\n* Surgical contraindication\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT04903860', 'acronym': 'LUUC', 'briefTitle': 'Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement', 'orgStudyIdInfo': {'id': 'RBHP 2021 ERIVAN'}, 'secondaryIdInfos': [{'id': '2021-A00363-38', 'type': 'OTHER', 'domain': '2021-A00363-38'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single use reamers', 'description': 'Total hip replacement with the use of disposable reamers', 'interventionNames': ['Device: total hip replacement with single use ancillary']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional ancillary', 'description': 'Total hip replacement with the use of conventional reamers', 'interventionNames': ['Device: total hip replacement with conventional ancillary']}], 'interventions': [{'name': 'total hip replacement with single use ancillary', 'type': 'DEVICE', 'description': 'Comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement', 'armGroupLabels': ['Single use reamers']}, {'name': 'total hip replacement with conventional ancillary', 'type': 'DEVICE', 'description': 'Comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement', 'armGroupLabels': ['conventional ancillary']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU clermont-ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Roger ERIVAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Groupe Lépine', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}