Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-29 @ 4:37 PM
Study NCT ID:
NCT04670900
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2020-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Olecranon Fractures in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092470', 'term': 'Olecranon Fracture'}], 'ancestors': [{'id': 'D000092482', 'term': 'Elbow Fractures'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014458', 'term': 'Ulna Fractures'}, {'id': 'D005543', 'term': 'Forearm Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patient instructed not to reveal treatment and to wear long sleeves.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized non-inferiority multicenter'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxford Elbow Score', 'timeFrame': '52 weeks', 'description': 'Patient reported 12 item form, 0 (worst) to 100 (best possible score)'}], 'secondaryOutcomes': [{'measure': 'Range of motion', 'timeFrame': '6 weeks', 'description': 'Extension, flexion, rotation'}, {'measure': 'Range of motion', 'timeFrame': '12 weeks', 'description': 'Extension, flexion, rotation'}, {'measure': 'Range of motion', 'timeFrame': '52 weeks', 'description': 'Extension, flexion, rotation measured in degrees total movement for each direction.'}, {'measure': 'Elbow extension strength', 'timeFrame': '6 weeks', 'description': 'Strength measured isometrically on a scale (grams) with elbow in 30 degrees flexion. Both arms measured for comparison.'}, {'measure': 'Elbow extension strength', 'timeFrame': '12 weeks', 'description': 'Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison.'}, {'measure': 'Elbow extension strength', 'timeFrame': '52 weeks', 'description': 'Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison. arms measured for comparison.'}, {'measure': 'Elbow satisfaction', 'timeFrame': '6 weeks', 'description': 'Single question: Are you satisfied with your elbow? Yes/Somewhat/No'}, {'measure': 'Elbow satisfaction', 'timeFrame': '12 weeks', 'description': 'Single question: Are you satisfied with your elbow? Yes/Somewhat/No'}, {'measure': 'Elbow satisfaction', 'timeFrame': '52 weeks', 'description': 'Single question: Are you satisfied with your elbow? Yes/Somewhat/No'}, {'measure': 'Complications', 'timeFrame': 'Through study period up to 52 weeks.', 'description': 'Serious local complications not reoperated.'}, {'measure': 'Number of Reoperations', 'timeFrame': 'Through study period up to 52 weeks.', 'description': 'Any reoperation'}, {'measure': 'Oxford Elbow Score', 'timeFrame': '6 weeks', 'description': 'Patient reported 12 item form, 0 (worst) to 100 (best possible score)'}, {'measure': 'Oxford Elbow Score', 'timeFrame': '12 weeks', 'description': 'Patient reported 12 item form, 0 (worst) to 100 (best possible score)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elderly patients', 'Surgery', 'Non-operative treatment', 'Functional outcome'], 'conditions': ['Olecranon Fracture']}, 'referencesModule': {'references': [{'pmid': '32818066', 'type': 'BACKGROUND', 'citation': 'Savvidou OD, Koutsouradis P, Kaspiris A, Naar L, Chloros GD, Papagelopoulos PJ. Displaced olecranon fractures in the elderly: outcomes after non-operative treatment - a narrative review. EFORT Open Rev. 2020 Aug 1;5(7):391-397. doi: 10.1302/2058-5241.5.190041. eCollection 2020 Jul.'}]}, 'descriptionModule': {'briefSummary': 'Operative treatment, with tension band wiring or plate fixation, will be compared with non-operative treatment of displaced olecranon fractures (Mayo classification 2A and 2B) in patients 75 years or older.', 'detailedDescription': 'Displaced olecranon fractures disrupt the extensor mechanism of the elbow and operative treatment is therefore usually recommended. Tension band wiring (TBW) and plate fixation (PF) are the most common surgical treatment options. Both methods are associated with high complication and reoperation rates, especially in elderly patients. Only one randomized controlled trial has compared operative and non-operative treatment of olecranon fractures in the elderly, but the study was stopped prematurely due to high complication rates in the group treated operatively and remained underpowered for important outcome measures.A few small patient series with non-operatively treated fractures also exist and suggest that it may be a valid alternative to operative treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Displaced olecranon fracture (Mayo 2A and 2B).\n\nExclusion Criteria:\n\n* Associated fractures in the coronoid process, radial head or distal humerus.\n* Open fracture, Gustilo-Andersen 2 or 3\n* Severe cardiopulmonary disease or other medical condition which contraindicates surgery.\n* Previous injury to or other condition in the elbow with serious functional impairment'}, 'identificationModule': {'nctId': 'NCT04670900', 'acronym': 'CROFT2', 'briefTitle': 'Treatment of Olecranon Fractures in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Operative or Non-Operative Treatment of Displaced Fractures of the Elderly - a Nordic Multicenter Randomized Trial', 'orgStudyIdInfo': {'id': 'REC2018/88'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Operative', 'description': 'Patients will be operated according to Orthopedic Trauma Association (OTA) principles with either tension band wiring or plate fixation with an anatomical precontoured plate.', 'interventionNames': ['Procedure: Tension band wiring or plate fixation']}, {'type': 'EXPERIMENTAL', 'label': 'Non-operative', 'description': 'Patients will be offered a plaster cast for 1-2 weeks', 'interventionNames': ['Procedure: Active non-operative treatment with optional plaster cast']}], 'interventions': [{'name': 'Tension band wiring or plate fixation', 'type': 'PROCEDURE', 'description': 'Choice of operative treatment is TBW or PF with a precontoured anatomical plate. The treating surgeon decides if TBW or PF is chosen as operative treatment method. The surgeries are performed according to OTA principles by an experienced surgeon, a trauma fellow or a consultant as approved by the participating hospitals.', 'armGroupLabels': ['Operative']}, {'name': 'Active non-operative treatment with optional plaster cast', 'type': 'PROCEDURE', 'description': 'Patients allocated to non-operative treatment are offered a back-slab in 60 degrees of flexion for pain-relief. The back-slab is removed 7-14 days following injury.', 'armGroupLabels': ['Non-operative']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sandvika', 'state': 'Gjettum', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Ellen Langslet, MD', 'role': 'CONTACT'}, {'name': 'Espen Laudal', 'role': 'CONTACT', 'email': 'ESLAUD@vestreviken.no'}], 'facility': 'Baerum Hospital', 'geoPoint': {'lat': 64.46377, 'lon': 13.59125}}, {'zip': '3511', 'city': 'Hønefoss', 'state': 'Norway', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Audun Tangerud, MD', 'role': 'CONTACT', 'email': 'audun.tangerud@gmail.com', 'phone': '+4732803000'}], 'facility': 'Vestre Viken Hospital Trust', 'geoPoint': {'lat': 60.16804, 'lon': 10.25647}}, {'city': 'Trondheim', 'state': 'Trønderlag', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Lars Gunnar Johnsen, PhD', 'role': 'CONTACT', 'email': 'lars.gunnar.johnsen@ntnu.no'}], 'facility': 'St. Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'city': 'Arendal', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Knut Erik Mjaaland, PhD', 'role': 'CONTACT', 'email': 'Knut.Erik.Mjaaland@sshf.no'}], 'facility': 'Arendal Hospital', 'geoPoint': {'lat': 58.46151, 'lon': 8.77253}}, {'city': 'Bergen', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Jostein Skorpa Nilsen, MD', 'role': 'CONTACT', 'email': 'j.skorpa@gmail.com'}], 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Grålum', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Frede Frihagen, PhD', 'role': 'CONTACT', 'email': 'ffrihagen@gmail.com', 'phone': '+4791332738'}], 'facility': 'Østfold Hospital Trust', 'geoPoint': {'lat': 59.29048, 'lon': 11.06668}}, {'zip': '0408', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'facility': 'Orthopedic Center, Ulleval University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Oslo', 'status': 'NOT_YET_RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Marius Coucheron, MD', 'role': 'CONTACT', 'email': 'Marius.Coucheron@diakonsyk.no', 'phone': '+4799298431'}, {'name': 'Bugge', 'role': 'CONTACT'}], 'facility': 'Diakonhjemmet Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Skien', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Hilde Apold, PhD', 'role': 'CONTACT', 'email': 'hildeapold@gmail.com'}], 'facility': 'Telemark Hospital', 'geoPoint': {'lat': 59.20962, 'lon': 9.60897}}, {'city': 'Stavanger', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Ane Djuv, PhD', 'role': 'CONTACT', 'email': 'ane.djuv@sus.no'}], 'facility': 'Stavanger University Hospital', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}, {'city': 'Tønsberg', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Tor Nicolaysen, MD', 'role': 'CONTACT'}], 'facility': 'Tønsberg Hospital', 'geoPoint': {'lat': 59.26754, 'lon': 10.40762}}, {'city': 'Uppsala', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Greta Snellman, MD', 'role': 'CONTACT', 'email': 'greta.snellman@surgsci.uu.se'}], 'facility': 'Akademiska Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Frede Frihagen, PhD', 'role': 'CONTACT', 'email': 'ffrihagen@gmail.com', 'phone': '+4791332738'}, {'name': 'Kaare S Midtgaard, MD', 'role': 'CONTACT', 'email': 'Kaare.midtgaard@gmail.com', 'phone': '+4793412696'}], 'overallOfficials': [{'name': 'Frede Frihagen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oslo'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Within 12 months', 'ipdSharing': 'YES', 'description': 'Publish protocol', 'accessCriteria': 'Open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Frede Frihagen', 'investigatorAffiliation': 'Oslo University Hospital'}}}}