Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-27 @ 1:02 PM
Study NCT ID:
NCT06972550
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2025-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volar Locked Plating for Distal Radius Fractures: Should the Pronator Quadratus Be Spared?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-05-03', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological bone union', 'timeFrame': '2 months, 4 months', 'description': 'an xray was done to determine if the bone ends had become united.'}], 'secondaryOutcomes': [{'measure': 'pain postoperatively by the Visual Analogue Scale (VAS) score', 'timeFrame': '2 months, 4 months', 'description': "pain is measured by a vas score both post operative and throughout the follow up period in a 10 point scale. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Distal radius fracture'], 'conditions': ['Distal Radius Fracture']}, 'descriptionModule': {'briefSummary': "Volar locked plates for the distal radius fractures (DRFs) are applied through the Henry approach and it's modification, this approach entails a routine step to disinsert the pronator quadratus from it's radial and distal attachment. This muscle insertion is mostly fleshy with minimal tendinous tissue and surgeons find it difficult to reattach at the end of the surgery, the hardware come in direct contact with the flexor tendons.", 'detailedDescription': "Distal radius fractures (DRFs) account for about 17.5% of all adult fractures and represent the most common fracture of the upper extremity. For severely displaced or unstable fractures, open reduction and internal fixation (ORIF) is often indicated. Volar locking plate fixation through the flexor carpi radialis (FCR) approach is widely used and considered a standard technique for distal radius fixation. Classically, the pronator quadratus (PQ) muscle is released from the radial side of the distal radius to expose the fracture and is later repaired after plate fixation. However, this repair is often not feasible or reliable. Some authors have suggested that failure to restore the PQ may leave the plate exposed to the flexor tendons, increasing the risk of tendon irritation or rupture.\n\nTo address these concerns, minimally invasive PQ-sparing approaches have been developed. Imatani et al. first described a technique for volar plating without detaching the PQ, and Dos Remedios et al. reported a similar approach. Theoretically, preserving the PQ creates a cushion between the plate and the flexor tendons and maintains the muscle's function. Several studies have reported better early functional outcomes and less pain post-operatively with PQ-sparing than the traditional approach.\n\nIn this prospective case series at a Level I trauma center with a dedicated hand surgery service, the PQ-sparing volar plating technique for distal radius fractures is evaluated. The study's main objectives were to determine whether the PQ can be preserved without compromising fracture reduction, to describe how a volar locking plate can be applied without releasing the PQ, to identify potential benefits of PQ preservation, and to assess any drawbacks of this approach."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* isolated closed distal radius fractures\n\nExclusion Criteria:\n\n* fractures \\>3 weeks old,\n* age \\>60 years (reflecting our practice of treating most low-demand elderly patients nonoperatively unless the fracture was highly unstable),\n* pathologic fractures (e.g. metastatic lesions).'}, 'identificationModule': {'nctId': 'NCT06972550', 'briefTitle': 'Volar Locked Plating for Distal Radius Fractures: Should the Pronator Quadratus Be Spared?', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Volar Locked Plating for Distal Radius Fractures: Should the Pronator Quadratus Be Spared?', 'orgStudyIdInfo': {'id': 'N-837-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pronator Quadratus sparing', 'description': 'The pronator quadratus was spared during ORIF of the fracture', 'interventionNames': ['Procedure: pronator quadratus sparing']}], 'interventions': [{'name': 'pronator quadratus sparing', 'type': 'PROCEDURE', 'description': 'the pronator quadratus was spared when doing orif and the plare was slided beneath it', 'armGroupLabels': ['Pronator Quadratus sparing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Ahmed Omar Sabry', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}