Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-30 @ 2:56 AM
Study NCT ID:
NCT05054868
Status:
UNKNOWN
Last Update Posted:
2023-07-12
First Post:
2021-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketorolac vs Oxycodone for Great Toe Arthrodesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000844', 'term': 'Ankylosis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}, {'id': 'D020910', 'term': 'Ketorolac'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-11', 'studyFirstSubmitDate': '2021-07-23', 'studyFirstSubmitQcDate': '2021-09-17', 'lastUpdatePostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bone fusion - doctor will review the 3 month postop x-ray to see if the bones have fused at the site of surgery', 'timeFrame': 'Approximately 90 days after surgery (or until 3-month post-op visit is completed)', 'description': 'To study if postop ketorolac affects bone fusion. This will be assessed by comparing the routine x-rays collected at the baseline visit to the routine x-rays taken at the 3-month postop visit.'}], 'primaryOutcomes': [{'measure': 'Pain scores - collected at baseline (standard of care) and for the study using a study survey on days 3, 7, and 14 after surgery.', 'timeFrame': 'From baseline to 14 days after the surgery', 'description': 'To study if postop ketorolac provides effective pain relief and helps reduce the need to take oxycodone. Participants will complete a short survey on Days 3, 7, and 14 after surgery. Participants will be asked to provide VAS pain scores, on a scale of 1-10, for the past 24 hours on Days 3, 7, and 14 after surgery.'}, {'measure': 'Quantitative pain management - measured using a study survey.', 'timeFrame': '14 days after the surgery', 'description': 'To study if postop ketorolac provides effective pain relief and helps reduce the need to take oxycodone. Participants will complete a short survey on Days 3, 7, and 14 after surgery. The survey will ask the following set of questions-\n\n* number of pills (oxycodone and/or ketorolac) consumed\n* if the pain medicine(s) needed to be refilled\n* discontinuation date \\& reason\n* side effects, if any\n* the effectiveness of the pain medicine(s)\n* preference for ketorolac or oxycodone, if applicable'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['big toe arthrodesis', 'big toe', 'joint fusion'], 'conditions': ['Arthrodesis']}, 'descriptionModule': {'briefSummary': 'This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.', 'detailedDescription': 'This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 75 years.\n* Women of childbearing potential must have a negative serum or urine pregnancy test results within 24 hours before the first dose of ketorolac.\n* Primary elective great toe MTP arthrodesis (CPT 28750). Other forefoot procedures often performed in conjunction with toe fusion will be included (CPT codes 28308, 28285, 28270).\n\nExclusion Criteria:\n\n* Chronic pain syndrome, CRPS or fibromyalgia\n* Revision procedures\n* Use of allograft bone at the fusion site\n* Tobacco use\n* Diabetes\n* Narcotic abuse or IV drug abuse\n* Any CPT codes involving the midfoot, hindfoot, and/or ankle\n* Unable to take NSAIDs secondary to medical comorbidities such as kidney disease (impaired renal function with CrCl ≤ 50 ml/min) or gastric ulcers\n* Weight \\< 50 kg\n* Does not speak or read English\n* If pregnant or planning to become pregnant or breastfeeding\n* Non-independent dweller (prisoner)'}, 'identificationModule': {'nctId': 'NCT05054868', 'briefTitle': 'Ketorolac vs Oxycodone for Great Toe Arthrodesis', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'Effect of Ketorolac Administration on Post-operative Narcotic Utilization and Union Rates in Great Toe Arthrodesis', 'orgStudyIdInfo': {'id': 'STUDY00001123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 (Control group) - Oxycodone only', 'description': 'Subjects randomized to this group will receive oxycodone for postop pain management (standard of care).', 'interventionNames': ['Drug: Oxycodone']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (Treatment group) - Oxycodone and Ketorolac', 'description': 'Subjects randomized to this group will receive oxycodone and ketorolac for postop pain management.', 'interventionNames': ['Drug: Oxycodone', 'Drug: Ketorolac']}], 'interventions': [{'name': 'Oxycodone', 'type': 'DRUG', 'description': 'Subjects randomized to the control group will receive oxycodone for postop pain management (standard of care).', 'armGroupLabels': ['Group 1 (Control group) - Oxycodone only', 'Group 2 (Treatment group) - Oxycodone and Ketorolac']}, {'name': 'Ketorolac', 'type': 'DRUG', 'description': 'Subjects randomized to the treatment group will receive oxycodone and ketorolac for postop pain management.', 'armGroupLabels': ['Group 2 (Treatment group) - Oxycodone and Ketorolac']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Loveland', 'role': 'CONTACT', 'email': 'amy.loveland@medstar.net', 'phone': '301-560-2937'}, {'name': 'Crisanto Macaraeg', 'role': 'CONTACT', 'email': 'crisanto.l.macaraeg@medstar.net', 'phone': '4102618218'}], 'facility': 'Amy Loveland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Amy Loveland', 'role': 'CONTACT', 'email': 'amy.loveland@medstar.net', 'phone': '3015602937'}, {'name': 'Crisanto Macaraeg', 'role': 'CONTACT', 'email': 'crisanto.l.macaraeg@medstar.net', 'phone': '410-261-8218'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}