Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT01484535
Status:
COMPLETED
Last Update Posted:
2015-07-17
First Post:
2011-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aspiration for Pain Relief Following Ankle Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064386', 'term': 'Ankle Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-16', 'studyFirstSubmitDate': '2011-11-30', 'studyFirstSubmitQcDate': '2011-12-01', 'lastUpdatePostDateStruct': {'date': '2015-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain as rated by numerical rating scale (NRS) scores in the emergency department and in the first 72 hours from the time of initial evaluation.', 'timeFrame': '6 months', 'description': 'Total amount of pain medication used in the first 72 hours from time of initial evaluation.'}], 'secondaryOutcomes': [{'measure': 'Percentage of volumetric increase of the injured ankle compared to the uninjured ankle.', 'timeFrame': '6 months', 'description': 'NRS scores after 72 hours through 6 months. 6 month SMFA scores. 6 month Olerud Molander scores.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ankle Fracture']}, 'descriptionModule': {'briefSummary': 'This trial will study the effect of hematoma aspiration in patients with acute ankle fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* AO/OTA fracture classification 44\n* Closed fracture\n* Injury within 24 hours of presentation\n* Skeletally mature\n* Able to provide consent to participate in study\n\nExclusion Criteria:\n\n* Any concomitant injuries affecting Numerical Rating Scale\n* Soft tissue wounds at aspiration sites that compromise ability to aspirate\n* Patient not able to complete pain medication log\n* Patient not able to participate in follow up'}, 'identificationModule': {'nctId': 'NCT01484535', 'briefTitle': 'Aspiration for Pain Relief Following Ankle Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Aspiration for Pain Relief Following Ankle Fracture: A Prospective Double-Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '11-004187'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ankle aspiration', 'description': 'ankle aspiration', 'interventionNames': ['Procedure: Ankle Aspiration']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo procedure', 'description': 'placebo procedure', 'interventionNames': ['Procedure: Ankle aspiration Standard Anterolateral']}], 'interventions': [{'name': 'Ankle Aspiration', 'type': 'PROCEDURE', 'description': 'Ankle aspiration will be performed through either a standard anterolateral or anteromedial approach, depending on the conditions of the soft tissue. The anterolateral approach will be the preferred method due to the higher reproducibility of intra-articular needle placement. The anteromedial approach will be reserved for patients whose soft tissues over the anterolateral portal are compromised. Sterile preparation of the limb will be achieved with the use of chlorhexidine or Betadine. An 18 gauge needle will be introduced into the ankle joint and a syringe will be used to aspirate the ankle until no more hemarthrosis is able to be removed. The amount of hemarthrosis aspirated will be recorded. Following the procedure, care will continue as per standard of care.', 'armGroupLabels': ['Ankle aspiration']}, {'name': 'Ankle aspiration Standard Anterolateral', 'type': 'PROCEDURE', 'description': 'Placebo ankle aspiration will be performed through a standard anterolateral. Sterile preparation of the limb will be achieved with the use of chlorhexidine or Betadine. An 18-gauge needle will be introduced into the skin. The needle will be held in the skin for 5-10 seconds in an effort to simulate the pain and time-lag experienced with aspiration. The needle will not pass the fascia or ankle joint capsule. Following the procedure, care will continue as per standard of care.', 'armGroupLabels': ['placebo procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Stephen Sems, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stephen A. Sems', 'investigatorAffiliation': 'Mayo Clinic'}}}}