Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 11:05 AM
Study NCT ID:
NCT06459557
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Pediatric Distal Radius Fractures : Conservative Treatment Versus Surgical Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011885', 'term': 'Radius Fractures'}], 'ancestors': [{'id': 'D005543', 'term': 'Forearm Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C119975', 'term': 'POLR1G protein, human'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2024-05-12', 'studyFirstSubmitQcDate': '2024-06-12', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean difference of Modifed the Disabilities of the Arm, Shoulder and Hand (m-DASH) score between the two groups', 'timeFrame': '12 months', 'description': 'functional assessment at 1.5 , 3 , 6 and 12 months posttrauma using the Modifed the Disabilities of the Arm, Shoulder and Hand (m-DASH) score as (50/50) (100%) is considered the maximum value which is the best outcome and (10/50) (0%) is considered the minimum value which is the worst outcome'}], 'secondaryOutcomes': [{'measure': 'Comparing palmar tilt angle between the 2 groups .', 'timeFrame': '12 months', 'description': 'radiological assessment poattraumatic at 1.5 , 3 , 6 ,12 months for lateral view of wrist joint for the 2 groups comparing palmar tilt angle which is the angle formed by a line drawn perpendicular to the axis of the radial shaft, and a line that passes through the tips of the dorsal and volar rims (i.e. along the radius articular surface)'}, {'measure': 'Comparing radial inclination between the 2 groups', 'timeFrame': '12 months', 'description': 'radiological assessment posttraumatic at 1.5 , 3 , 6 ,12 months for anterioposterior view of wrist joint for the 2 groups comparing radial inclination which is the angle between a line drawn perpendicular to the long axis of the radius along the articular surface of the distal radius and a line drawn down from the tip of the radial styloid'}, {'measure': 'Comparing radius length between the 2 groups', 'timeFrame': '12 months', 'description': 'radiological assessment posttraumatic at 1.5 , 3 , 6 ,12 months for anterioposterior view of wrist joint for the 2 groups comparing radius length which is the distance between two lines drawn perpendicular to the long axis of the radius on the AP projection from the apex of the radial styloid and level of the ulnar aspect of the articular surface'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fracture, Radius']}, 'referencesModule': {'references': [{'pmid': '30430048', 'type': 'BACKGROUND', 'citation': 'Akar D, Koroglu C, Erkus S, Turgut A, Kalenderer O. Conservative Follow-up of Severely Displaced Distal Radial Metaphyseal Fractures in Children. Cureus. 2018 Sep 5;10(9):e3259. doi: 10.7759/cureus.3259.'}, {'pmid': '36299238', 'type': 'BACKGROUND', 'citation': 'Shah AS, Guzek RH, Miller ML, Willey MC, Mahan ST, Bae DS; Pediatric Distal Radius Fracture (PDRF) Study Group. Descriptive Epidemiology of Isolated Distal Radius Fractures in Children: Results From a Prospective Multicenter Registry. J Pediatr Orthop. 2023 Jan 1;43(1):e1-e8. doi: 10.1097/BPO.0000000000002288. Epub 2022 Oct 26.'}, {'pmid': '17940779', 'type': 'BACKGROUND', 'citation': 'Hove LM, Brudvik C. Displaced paediatric fractures of the distal radius. Arch Orthop Trauma Surg. 2008 Jan;128(1):55-60. doi: 10.1007/s00402-007-0473-x. Epub 2007 Oct 17.'}, {'pmid': '30276723', 'type': 'BACKGROUND', 'citation': 'Sengab A, Krijnen P, Schipper IB. Displaced distal radius fractures in children, cast alone vs additional K-wire fixation: a meta-analysis. Eur J Trauma Emerg Surg. 2019 Dec;45(6):1003-1011. doi: 10.1007/s00068-018-1011-y. Epub 2018 Oct 1.'}, {'pmid': '34738560', 'type': 'BACKGROUND', 'citation': 'Marinelli M, Massetti D, Facco G, Falcioni D, Coppa V, Maestri V, Gigante A. Remodeling of distal radius fractures in children: preliminary retrospective cost/analysis in level II pediatric trauma center. Acta Biomed. 2021 Nov 3;92(5):e2021390. doi: 10.23750/abm.v92i5.11971.'}, {'pmid': '33995859', 'type': 'BACKGROUND', 'citation': "Naik P. Remodelling in Children's Fractures and Limits of Acceptability. Indian J Orthop. 2021 Mar 10;55(3):549-559. doi: 10.1007/s43465-020-00320-2. eCollection 2021 Jun."}, {'pmid': '32058553', 'type': 'BACKGROUND', 'citation': 'Orland KJ, Boissonneault A, Schwartz AM, Goel R, Bruce RW Jr, Fletcher ND. Resource Utilization for Patients With Distal Radius Fractures in a Pediatric Emergency Department. JAMA Netw Open. 2020 Feb 5;3(2):e1921202. doi: 10.1001/jamanetworkopen.2019.21202.'}, {'pmid': '18368935', 'type': 'BACKGROUND', 'citation': 'Colovic H, Stankovic I, Dimitrijevic L, Zivkovic V, Nikolic D. The value of modified DASH questionnaire for evaluation of elbow function after supracondylar fractures in children. Vojnosanit Pregl. 2008 Jan;65(1):27-32. doi: 10.2298/vsp0801027c.'}]}, 'descriptionModule': {'briefSummary': 'To compare functional and radiological assessment between two groups of children with displaced distal radius fractures : those who will receive surgical reduction and those who will not.', 'detailedDescription': 'Distal radius fractures are the most frequent fractures seen in pediatric population accounting for about 20-30% of all fractures in children , for the non-displaced pediatric distal radius fractures , it is agreed widely to be just managed by an immobilization cast in the emergency department . However when it comes to the displaced fractures , Different centers have different options of management , mostly including either the surgical anatomical reduction under general anesthesia then casting with or without using other fixation method which is mostly k-wires , or the other option includes only casting in the emergency department without trial of reduction or just a trial of realignment under sedating agent , this second option depends on the unique phenomenon of remodeling in the pediatric fractures , as Unlike adults, in growing children, remodeling can restore the alignment of the displaced fractures to a certain extent, making anatomical reduction less essential , specially when it comes to distal radius as The distal radial and ulnar physes are responsible for about 80% of forearm length and for 40% of upper limb length that making their remodeling potential can approach upto 100% . depending on that the question was that if the fracture will be fully remodeled with no functional or range of motion disturbance on the conservative option so what the essentiality of the surgical option can be . along with exposing the child to the dangers of general anesthesia , the minor complications that can occur with k wires (as neuropraxia , pin tract infection or migration of the k wire) , emotional and financial load . in a cost analysis for different options of treatment in displaced pediatric distal radius fractures , the cost of surgical option exceeds the conservative one by multiple times . According to that a lot of the current literature have suggested to consider conservative treatment of pediatric displaced distal radius fractures to be the gold standard and fundamental option of treatment . In this study the investigators question the effectiveness of conservative treatment to displaced pediatric distal radius fractures (casting in the emergency department) in comparison to the surgical anatomical reduction in matters of functional and radiological parameters .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children aged 3 to 10 years\n* both genders\n* patients presenting with displaced distal radius fractures\n\nExclusion Criteria:\n\n* intra articular fractures\n* Greenstick and buckle fractures\n* fractures with more than 1 week duration\n* non displaced fractures\n* Salter Harris fractures\n* open fractures\n* fractures with neurovascular bundle injury\n* poly trauma patients\n* patients with pathological bone diseases as Osteogenesis Imperfecta or CP (cerebral palsy) .\n* Galeazzi fractures'}, 'identificationModule': {'nctId': 'NCT06459557', 'briefTitle': 'Management of Pediatric Distal Radius Fractures : Conservative Treatment Versus Surgical Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Management of Pediatric Distal Radius Fractures : Conservative Treatment Versus Surgical Reduction - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'casting of distal radius'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conservative treatment of displaced pediatric distal radius fractures', 'description': 'children in this group with displaced distal radius fractures would be managed by a cast in the emergency room without anatomically reducing the fracture under general anesthesia in the operating room', 'interventionNames': ['Procedure: cast']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'surgical reduction of displaced distal radius fractures', 'description': 'children in this group with displaced distal radius fractures would be managed by being anatomically reducing the fracture in the operating room under general anesthesia', 'interventionNames': ['Procedure: surgical reduction']}], 'interventions': [{'name': 'cast', 'type': 'PROCEDURE', 'description': 'children with displaced distal radius fractures would be managed by a cast in the emergency room', 'armGroupLabels': ['conservative treatment of displaced pediatric distal radius fractures']}, {'name': 'surgical reduction', 'type': 'PROCEDURE', 'description': 'anatomical reduction of pediatric displaced distal radius fractures under general anesthesia in the operating room', 'armGroupLabels': ['surgical reduction of displaced distal radius fractures']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Omar Hasan, resident', 'role': 'CONTACT', 'email': 'Omar.15235482@med.aun.edu.eg', 'phone': '01145422265'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident', 'investigatorFullName': 'Omar Hasan Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}