Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-28 @ 12:42 PM
Study NCT ID:
NCT07006168
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2025-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects Of Intra-Operative Intra-Articular Cocktail Injection In Patella Open Reduction And Internal Fixation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092462', 'term': 'Patella Fracture'}], 'ancestors': [{'id': 'D000092443', 'term': 'Knee Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be allocated to receive either Intra-articular Cocktail Injection (IA Cocktail) OR receive no Injection (Control).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2025-05-15', 'studyFirstSubmitQcDate': '2025-05-27', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain as measured by Numerical Patient Reported Scale (NRPS)', 'timeFrame': 'Pre-op, Post-op Day 1 to 3', 'description': 'Numerical Patient Reported Scale (NRPS), 0 (no pain) to 10 (worst pain imaginable)'}, {'measure': 'Maximum Active Knee Flexion', 'timeFrame': 'At post-op Day 1 to 3', 'description': "The patient's Knee flexion is measured by a physiotherapist"}, {'measure': 'Oral analgesics consumed', 'timeFrame': 'Post-operative 2 weeks period', 'description': 'The level of the analgesic consumed (non-opioids, weak opioids, strong opioids), and the frequency of consumption'}, {'measure': 'Tegner Lysholm Knee Score', 'timeFrame': 'Post-op Day 14', 'description': 'The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema. Scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor.'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'Post-op Day 14', 'description': "The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used, and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems), and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved."}, {'measure': '9-item Quality of Recovery Score (QoR-9 Score)', 'timeFrame': 'Post-op Day 1 to 3', 'description': 'The QoR-9 has 9 questions evaluating the quality of recovery after surgery and anaesthesia. It is a patient-rated score ranging from 0 (worst) to 2 (best).'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The number of days the patient was hospitalised'}, {'measure': 'Time to radiological bony union', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'X-rays will be taken at different follow-up intervals (post-op 2 weeks, 6 weeks, 3 months, 6 months, 12 months). The X-rays will be assessed for bony union at the surgical site.'}, {'measure': 'Incidence of Complications', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Complications such as fracture site infection, loss of reduction, non-union, and malunion will be assessed and recorded'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intra-Articular analgesic injection', 'Pain relief', 'Open Reduction and Internal Fixation', 'Functional Recovery', 'Rehabilitation', 'Range of motion', 'Post-operative recovery'], 'conditions': ['Patella Fracture']}, 'referencesModule': {'references': [{'pmid': '38592262', 'type': 'BACKGROUND', 'citation': 'Baid M, Narula S, Manara JR, Blakeney W. Evolution in the Management of Patella Fractures. J Clin Med. 2024 Feb 29;13(5):1426. doi: 10.3390/jcm13051426.'}, {'pmid': '23955187', 'type': 'BACKGROUND', 'citation': 'Petrie J, Sassoon A, Langford J. Complications of patellar fracture repair: treatment and results. J Knee Surg. 2013 Oct;26(5):309-12. doi: 10.1055/s-0033-1353990. Epub 2013 Aug 16.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to demonstrate the safety and efficacy of an intra-articular analgesics cocktail injection for post-operative patella fracture fixation patients, by comparing post-operative pain relief and functional recovery among study subjects who received the injection and those who did not receive the injection. Secondary objective is to demonstrate the health economic effects of intra-articular analgesics cocktail injection by reducing length of hospital stay and reducing bed-stay related complications.', 'detailedDescription': 'This is a single-centre, double-blinded, randomised control trial that evaluates the efficacy of intra-articular analgesics cocktail injection in post-operative pain relief and functional recovery for fractured patella fixation patients. The recruited study subjects will be randomised to the two study groups respectively in a 1:1 randomisation ratio.\n\nPatella is the largest sesamoid bone in the human body, it acts as the fulcrum of our knee extensor apparatus and is important during the gait cycle. Patella fracture commonly occurs after a fall on a flexed knee. Treatment can be conservative or surgical with open reduction and internal fixation. Patients often experience significant pain around the knee post-operatively, limiting their walking ability and hindering their rehabilitation. As a result, total hospital stay will be prolonged, leading to hospital stay-related morbidity and additional healthcare economic burden.\n\nPrevious studies have shown that the use of an analgesic cocktail injection in arthroplasty cases can significantly reduce early postoperative pain and provide better early motion. The cocktail regime is as follows for a unilateral joint:\n\nKetoralac 15mg Ropivacaine 1% 15ml 0.9% Normal Saline 35ml Adrenaline 1:1000 0.5ml Stacort-A Triamcinolone Acetonide 40mg Total Cocktail Volume \\~50ml\n\nAfter fracture fixation, patients in the intervention group will receive an intra-articular injection of the above analgesic cocktail, while patients in the control group will not receive an injection.\n\nHerein this study, the investigators hope to demonstrate the safety and efficacy of an intra-articular analgesics cocktail injection for post-operative patella fracture fixation patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute patella fracture requiring open reduction and internal fixation;\n* able to consent to surgery;\n* pre-morbid able to ambulate\n\nExclusion Criteria:\n\n* open fracture;\n* polytrauma;\n* previous knee arthroplasty;\n* history of chronic pain,\n* insulin-dependent diabetes mellitus, or peptic ulcer disease;\n* chronic users of glucocorticoids, immunosuppressants, or immune-modulating agents, or of strong opioids (e.g.: morphine, fentanyl, hydromorphone, methadone, oxycodone, or meperidine);\n* hepatitis B or C carrier;\n* renal impairment (creatinine \\[Cr\\], \\>200 mmol/L)'}, 'identificationModule': {'nctId': 'NCT07006168', 'briefTitle': 'Effects Of Intra-Operative Intra-Articular Cocktail Injection In Patella Open Reduction And Internal Fixation', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Effects Of Intra-Operative Intra-Articular Cocktail Injection In Patella Open Reduction And Internal Fixation (ORIF): A Single Centre, Double Blinded, Randomised Control Trial', 'orgStudyIdInfo': {'id': 'UW 24-611'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intra-Articular Cocktail Injection', 'description': 'After fixation, an intra-articular cocktail injection is injected into the surgical site. The intra-articular cocktail regime: Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg. The total cocktail volume is approximately 50ml.', 'interventionNames': ['Drug: Ketorolac 15mg', 'Drug: Triamcinolone Acetonide 40mg', 'Drug: Ropivacaine HCL 1% 15ml', 'Drug: 0.9 % Normal Saline 35ml', 'Drug: Adrenaline 1:1000 0.5ml']}, {'type': 'NO_INTERVENTION', 'label': 'No Injection', 'description': 'No injection will be given to the patient.'}], 'interventions': [{'name': 'Ketorolac 15mg', 'type': 'DRUG', 'description': 'An intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery.', 'armGroupLabels': ['Intra-Articular Cocktail Injection']}, {'name': 'Triamcinolone Acetonide 40mg', 'type': 'DRUG', 'description': 'An intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery.', 'armGroupLabels': ['Intra-Articular Cocktail Injection']}, {'name': 'Ropivacaine HCL 1% 15ml', 'type': 'DRUG', 'description': 'An intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery.', 'armGroupLabels': ['Intra-Articular Cocktail Injection']}, {'name': '0.9 % Normal Saline 35ml', 'type': 'DRUG', 'description': 'An intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery.', 'armGroupLabels': ['Intra-Articular Cocktail Injection']}, {'name': 'Adrenaline 1:1000 0.5ml', 'type': 'DRUG', 'description': 'An intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery.', 'armGroupLabels': ['Intra-Articular Cocktail Injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'state': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Christian FANG', 'role': 'CONTACT', 'email': 'cfang@hku.hk', 'phone': '+852 22554581'}], 'facility': 'Queen Mary Hospital, The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Christian FANG', 'role': 'CONTACT', 'email': 'cfang@hku.hk', 'phone': '+852 22554581'}, {'name': 'Christian Fang', 'role': 'CONTACT', 'email': 'cfang@hku.hk', 'phoneExt': '+852 22554581'}], 'overallOfficials': [{'name': 'Christian Fang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Orthopaedics and Traumatology, Queen Mary Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'Anonymized dataset to be included as supplementary data in the final publication', 'accessCriteria': 'Additional information available upon reasonable request of principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Prof. Christian Xinshuo Fang', 'investigatorAffiliation': 'The University of Hong Kong'}}}}