Ignite Creation Date:
2025-12-24 @ 2:21 PM
Ignite Modification Date:
2026-02-23 @ 9:21 PM
Study NCT ID:
NCT03100695
Status:
UNKNOWN
Last Update Posted:
2021-03-25
First Post:
2017-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-22', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2017-03-28', 'lastUpdatePostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to healing', 'timeFrame': '2 weeks, 8 weeks, 12 weeks,16 weeks, 20 weeks, 26 weeks, 39 weeks', 'description': 'Healing will be assessed both clinically and radiologically (RUST score)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unilateral Tibial Diaphyseal Fracture']}, 'descriptionModule': {'briefSummary': 'A prospective, randomised study is to investigate the feasibility of conducting a superiority randomised controlled trial comparing the application of combined autologous PRP and concentrated autologous bone marrow (PRP-BMA) in addition to standard of care (either reamed intramedullary nailing or fine wire ring external fixator) for patients presenting with fresh tibial diaphyseal fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-65, skeletally mature adults.\n* Acute unilateral closed tibia diaphyseal fractures as the primary injury.\n* Definitive fracture fixation with reamed intramedullary nailing (statically locked) or fine wire ring external fixator to be performed within 14 days from the date of injury.\n* Willing and able (in the opinion of the study team) to provide informed consent and participate in all study activities.\n\nExclusion Criteria:\n\n* Open/compound tibial fracture.\n* Fracture Type 42-C2 according to Muller AO classification.\n* Multi-segmental nature of this fracture (more than one fracture site within tibia for intervention.)\n* Polytrauma (defined as injury severity score of 17 or more.)\n* Prior or concomitant illnesses that may affect healing.\n* Exposure to drugs that can affect the bone metabolic state within the past three months.\n* Receiving chemotherapy, radiation treatment or immunosuppression drugs.\n* Currently enrolled in any other study which may impact on the results of the present study.\n* If female: pregnancy, breast-feeding, not currently using and not willing to use an effective form of contraception for 12 months post-surgery.'}, 'identificationModule': {'nctId': 'NCT03100695', 'acronym': 'T-PAC', 'briefTitle': 'Tibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate', 'organization': {'class': 'OTHER', 'fullName': 'University of Leeds'}, 'officialTitle': 'A Prospective, Randomised, Single-centre Feasibility Study of Combined Autologous Platelet-rich Plasma and Concentrated Autologous Bone Marrow in Adult Patients With a Fresh Unilateral Tibial Diaphyseal Fracture Treated With Either Fine Wire Ring Fixator Device (Ilizarov) or Reamed Intramedullary Nailing', 'orgStudyIdInfo': {'id': '226136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients will undergo operative procedure with no additional intervention.'}, {'type': 'EXPERIMENTAL', 'label': 'Study', 'description': 'Patients will undergo usual operative procedure with the addition of an injection of autologous, concentrated PRP-BMA at the site of fixation.', 'interventionNames': ['Other: Concentrated autologous PRP-BMA']}], 'interventions': [{'name': 'Concentrated autologous PRP-BMA', 'type': 'OTHER', 'description': 'Injection of autologous, concentrated platelet-rich plasma and bone marrow aspirate at the site of fixation.', 'armGroupLabels': ['Study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds General Infirmary', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leeds', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'PeterGiannoudis', 'investigatorAffiliation': 'University of Leeds'}}}}