Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-03-05 @ 6:57 PM
Study NCT ID:
NCT01952067
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2013-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Cementing Techniques of the Femoral Component in a Hip Prosthesis
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2013-09-05', 'studyFirstSubmitQcDate': '2013-09-26', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in subsidence of femoral stems of 200 microns', 'timeFrame': 'change from 6th day postoperative to 24 months', 'description': 'Radiostereometric analysis (RSA) of implant migration: difference in translation and rotation (x-, y-, and z- axis) of the femoral stem'}], 'secondaryOutcomes': [{'measure': 'Oxford Hip Score', 'timeFrame': 'change from 6th day postoperative to 24 months', 'description': '12 questions. Every question is scored 4 to 0 according to the selected response.\n\nThus it is a continuous score ranging from 48-0. Each of the 12 questions on the Oxford hip score is scored in the same way with the score decreasing as the reported symptoms increase (ie. become worse). All questions are laid out similarly with response categories denoting least (or no) symptoms being to the left of the page (scoring 4) and those representing greatest severity lying on the right hand side (scoring 0).'}, {'measure': 'EQ-5D-5L', 'timeFrame': 'change from 6th day postoperative to 24 months', 'description': "5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be' 12233' We then convert this specific health state to an index value specific for that country. The index value calculator can be downloaded from the EuroQol Office. 5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be' 12233' We then convert this specific health state to an index value specific for that country. The index value calculator can be downloaded from the EuroQol Office."}, {'measure': 'Harris Hip Score (HHS)', 'timeFrame': 'change from 6th day postoperative to 24 months', 'description': 'Four subscales make up HHS. The first is pain, which measures pain severity (44 points); function, which is made up of daily activities and gait (47 points); the absence of deformity, which is a subscale that measures hip flexion, adduction, internal rotation, leg length discrepancy and range of motion measures.(4 points), and range of motion (5 points).\n\nThe survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.'}, {'measure': 'Visual Assessment Scale (VAS) for pain', 'timeFrame': 'change from 6th day postoperative to 24 months', 'description': "A horizontal or vertical 10 cm line labelled at each end by descriptors such as 'no pain' and 'worse pain ever'. The patient marks the line to indicate pain severity and it is simply quantified by measuring the distance in cm from 0 (no pain) to the patient's marked rating."}, {'measure': "Merle D'Aubigne scale", 'timeFrame': 'change from 6th day postoperative to 24 months', 'description': 'The score includes the parameters pain, mobility, and ability to walk, with each rated from 0 points (worst condition) to 6 points (best condition). Addition of the scores for pain and mobility results in an absolute estimation of hip function.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hip Prosthesis', 'surgery', 'cements', 'Radiostereometric Analysis'], 'conditions': ['Osteoarthritis, Hip']}, 'referencesModule': {'references': [{'pmid': '34969272', 'type': 'RESULT', 'citation': 'Sevaldsen K, Schnell Husby O, Lian OB, Farran KM, Schnell Husby V. Is the French Paradox cementing philosophy superior to the standard cementing? A randomized controlled radiostereometric trial and comparative analysis. Bone Joint J. 2022 Jan;104-B(1):19-26. doi: 10.1302/0301-620X.104B1.BJJ-2021-0325.R2.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of the study is to compare migration of the cemented Corail stem representing polished surfaced versions of the femoral stem. Two different methods will be used for reaming the femoral canal and cementing of the stem. Radiostereometric analysis (RSA) will be used in migration measurements.\n\nFurthermore pain, postoperative outcome and patient satisfaction will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients requiring cemented primary total hip replacement.\n* Patients with a diagnosis of osteoarthritis, avascular necrosis or post-traumatic arthritis\n* Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation\n* Patient who signed the Ethics Committee approved specific Informed Consent Form prior to surgery\n\nExclusion Criteria:\n\n* Patients who require revision of a previously implanted total hip replacement (THR)\n* Patients who will receive a THR without cement\n* Patients who have had a prior procedure of osteotomy on the femur\n* Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI \\>35)\n* Patients with active or suspected infection\n* Patients with malignancy"}, 'identificationModule': {'nctId': 'NCT01952067', 'briefTitle': 'Comparison of Two Cementing Techniques of the Femoral Component in a Hip Prosthesis', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Comparison of Two Cementing Techniques of the Femoral Component in a Hip Prosthesis. A Randomized Single-blind Trial', 'orgStudyIdInfo': {'id': '4.2008.1996'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'line-to-line reaming', 'description': 'Corail cemented femoral stem using line-to-line reaming and cementing technique, 28mm Alumine Biolox forte femoral head, Marathon cup', 'interventionNames': ['Procedure: line-to-line reaming and cementing technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard over-reaming', 'description': 'Corail cemented femoral stem using standard over-reaming with 2 broach sizes, 28mm Alumine Biolox forte femoral head, Marathon cup', 'interventionNames': ['Procedure: standard over-reaming with 2 broach sizes']}], 'interventions': [{'name': 'line-to-line reaming and cementing technique', 'type': 'PROCEDURE', 'armGroupLabels': ['line-to-line reaming']}, {'name': 'standard over-reaming with 2 broach sizes', 'type': 'PROCEDURE', 'armGroupLabels': ['standard over-reaming']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kristiansund', 'country': 'Norway', 'facility': 'Kristiansund Hospital', 'geoPoint': {'lat': 63.11045, 'lon': 7.72795}}], 'overallOfficials': [{'name': 'Otto Schnell Husby, md phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kristiansund Hospital', 'class': 'OTHER'}, {'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}