Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT07142369
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synovial Fluid Withdrawal or PRP Injection For Acute ACL Tears and Cytokines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069237', 'term': 'Arthrocentesis'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D019152', 'term': 'Paracentesis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial 1:1:1 study assignment (33 subjects Arm 1 two arthrocentesis withdrawals; 33 subjects Arm 2 two arthrocentesis withdrawals with PRP injection; 33 subjects Arm 3 a very small arthocentesis withdrawal and one standard arthrocentesis withdrawal and no PRP injection)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 99}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of Collagen Type II Cytokine', 'timeFrame': 'Enrollment up to surgery', 'description': 'Breakdown cytokine found in damaged cartilage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoarthritis'], 'conditions': ['Posttraumatic Osteoarthritis', 'Anterior Cruciate Ligament (ACL) Rupture']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine what effects the withdrawal of excess knee joint fluid or the injection of a factor from the blood has on swelling after a sudden anterior cruciate ligament (ACL) rupture of the knee.', 'detailedDescription': 'The body responds to different stresses by releasing factors in the blood and fluids in response to stressors like injury, surgery or certain treatments. Some of these factors help heal and some make the injury and body swell (inflammation). In this study we want to see if the intervention of withdrawing fluid the knee or the addition of an enriched healing factor called platelet rich plasma (PRP) injected in the knee influences the body to produce healing factors in the knee joint fluid.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 50\n* English-speaking\n* Clinical evidence of ACL rupture with swelling\n* Participant must be undergoing ACL reconstruction surgery\n\nExclusion Criteria:\n\n* Age \\<18 or \\>50\n* Presentation \\>3 weeks after initial injury\n* Previous traumatic ipsilateral (same side) knee injury consistent with chronic ACL tear or prior ACL surgery\n* \\> Kellgren-Lawrence grade 2 changes on preoperative x-ray\n* History of hemophilia or inflammatory arthropathy (e.g., rheumatoid arthritis)'}, 'identificationModule': {'nctId': 'NCT07142369', 'briefTitle': 'Synovial Fluid Withdrawal or PRP Injection For Acute ACL Tears and Cytokines', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Does Arthrocentesis and PRP For Acute ACL Tears With Hemarthrosis Decrease Inflammatory Cytokines At Time Of Surgery: A Prospective Randomized Control Trial (RCT)', 'orgStudyIdInfo': {'id': '24120505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Two Synovial Fluid Withdrawals', 'description': 'Subjects randomized to Arm 1 will have 2 synovial fluid withdrawals; one at the preoperative clinic visit and one at the time of surgery', 'interventionNames': ['Procedure: Synovial Fluid withdrawal at the preoperative clinic visit', 'Procedure: Synovial fluid withdrawal at the time of surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Platelet-Rich Plasma (PRP) and Two Synovial Fluid Withdrawals', 'description': 'Subjects randomized to ARM 2 will have 2 synovial fluid withdrawals one at the preoperative visit and one at the time of surgery. Platelet-Rich Plasma (PRP) preparation and injection will happen at the preoperative clinic visit.', 'interventionNames': ['Procedure: Synovial Fluid withdrawal at the preoperative clinic visit', 'Procedure: Platelet-Rich Plasma (PRP) preparation and injection', 'Procedure: Synovial fluid withdrawal at the time of surgery']}, {'type': 'OTHER', 'label': '3mL Synovial Fluid Withdrawal and Synovial Fluid Withdrawal at the Time of Surgery', 'description': 'Subjects randomized to Arm 3 will have 3mL withdrawal of synovial fluid at the preoperative visit and 1 synovial fluid withdrawal at the time of surgery', 'interventionNames': ['Procedure: Synovial fluid withdrawal at the time of surgery', 'Procedure: 3mL synovial fluid withdrawn at the preoperative visit']}], 'interventions': [{'name': 'Synovial Fluid withdrawal at the preoperative clinic visit', 'type': 'PROCEDURE', 'otherNames': ['arthrocentesis'], 'description': 'Synovial Fluid withdrawal at the preoperative clinic visit', 'armGroupLabels': ['Platelet-Rich Plasma (PRP) and Two Synovial Fluid Withdrawals', 'Two Synovial Fluid Withdrawals']}, {'name': 'Platelet-Rich Plasma (PRP) preparation and injection', 'type': 'PROCEDURE', 'otherNames': ['platelet rich plasma'], 'description': 'Platelet-Rich Plasma (PRP) preparation and injection', 'armGroupLabels': ['Platelet-Rich Plasma (PRP) and Two Synovial Fluid Withdrawals']}, {'name': 'Synovial fluid withdrawal at the time of surgery', 'type': 'PROCEDURE', 'description': 'Synovial fluid withdrawal at the time of surgery', 'armGroupLabels': ['3mL Synovial Fluid Withdrawal and Synovial Fluid Withdrawal at the Time of Surgery', 'Platelet-Rich Plasma (PRP) and Two Synovial Fluid Withdrawals', 'Two Synovial Fluid Withdrawals']}, {'name': '3mL synovial fluid withdrawn at the preoperative visit', 'type': 'PROCEDURE', 'description': '3mL synovial fluid withdrawn at the preoperative visit', 'armGroupLabels': ['3mL Synovial Fluid Withdrawal and Synovial Fluid Withdrawal at the Time of Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Adam Yanke, MD, PhD', 'role': 'CONTACT', 'email': 'cartilage.restoration@rushortho.com', 'phone': '(312) 432-2818'}, {'name': 'Jorge Chahla, MD, PhD', 'role': 'CONTACT', 'email': 'jorge.chahla@rushortho.com'}], 'overallOfficials': [{'name': 'Adam Yanke, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor and Surgeon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Arthroscopy Association of North America (AANA)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}