Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT03378557
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2017-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periprosthetic Fracture Registry (PPFx)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057068', 'term': 'Periprosthetic Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2017-11-14', 'studyFirstSubmitQcDate': '2017-12-19', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Classification of the fracture', 'timeFrame': 'Pre-operatively (Day -1)', 'description': 'Classification of the fracture using the UCS and some parts of the AO/OTA fracture classification system.'}], 'secondaryOutcomes': [{'measure': 'Fracture mechanism', 'timeFrame': 'Pre-operatively (Day -1)', 'description': 'High / low energy trauma, pathological fracture, stem stability'}, {'measure': 'Rehabilitation program', 'timeFrame': 'Up to 12 months', 'description': 'weight bearing, bedrest, splint'}, {'measure': 'Function of hip or knee', 'timeFrame': 'Up to 12 months', 'description': 'Harris Hip Score or Knee Society score'}, {'measure': 'Health related quality of life', 'timeFrame': 'Up to 12 months', 'description': 'PROMIS pain interference and physical activity'}, {'measure': 'Fracture healing', 'timeFrame': 'Up to 12 months', 'description': 'by RUSH or RUST score'}, {'measure': 'pain visual analog scale (VAS) and pain medication', 'timeFrame': 'Up to 12 months', 'description': 'Using the pain visual analog scale (VAS) and pain medication'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periprosthetic Fractures', 'Periprosthetic Fracture Around Prosthetic Joint Implant']}, 'referencesModule': {'references': [{'pmid': '39110721', 'type': 'DERIVED', 'citation': 'Uzoigwe CE, Watts AT, Briggs P, Symes T. Periprosthetic Femoral Fractures-Beyond B2. J Am Acad Orthop Surg Glob Res Rev. 2024 Aug 6;8(8):e23.00135. doi: 10.5435/JAAOSGlobal-D-23-00135. eCollection 2024 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'This registry supports international data collection and research on PPFx treatments after hip and knee arthroplasty.\n\nA registry such as this ultimately aims to provide far-reaching benefits to society including reduced morbidity and mortality, improved patient safety, improved quality of care and medical decision-making, reduced medical spending, and advances in orthopaedic science.', 'detailedDescription': 'To close the gap of missing clinical evidence regarding the treatment of periprosthetic fractures after arthroplasty of the hip or the knee with osteosynthesis.\n\nTo drive further study hypotheses and to answer unforeseen questions.\n\nMain questions to be answered by the registry include (but are not exclusive) the following:\n\n1. Influence of implants on outcome\n2. Influence of surgical techniques on outcome\n3. Influence of bone grafting on outcome\n4. Identification of risk factors for failure\n5. Identification of postoperative rehabilitation programs and its possible influence on the outcome\n6. Influence of fracture type on outcome\n7. To serve as a comparative dataset for future studies with improved implants and techniques'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with total or hemi hip or knee arthroplasty and who have a fracture around one of the arthroplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n\n * Post-operative PPFx after total or hemi hip or total or unicondylar knee arthroplasty (including the acetabulum, femur, patella and proximal tibia) requiring\n\n * osteosynthesis alone or\n * component revision plus plate/nail osteosynthesis\n * Informed consent obtained, i.e.:\n\n * Ability of the patient or assigned representative to understand the content of the patient information / Informed Consent Form\n * Signed and dated EC / IRB approved written informed consent\n * Ability to attend post-operative follow up visits\n\nExclusion Criteria:\n\n* Pregnancy or women planning to conceive within the study period\n* Prisoner'}, 'identificationModule': {'nctId': 'NCT03378557', 'acronym': 'PPFx', 'briefTitle': 'Periprosthetic Fracture Registry (PPFx)', 'organization': {'class': 'OTHER', 'fullName': 'AO Innovation Translation Center'}, 'officialTitle': 'Multicenter Prospective Registry for Periprosthetic Fractures After Hip or Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'PPFx'}}, 'contactsLocationsModule': {'locations': [{'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gregory Della Rocca, MD', 'role': 'CONTACT', 'email': 'dellaroccag@health.missouri.edu'}], 'facility': 'University of Missouri Health Care', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '07302', 'city': 'Jersey City', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Frank A. Liporace, MD', 'role': 'CONTACT', 'email': 'liporace33@gmail.com', 'phone': '2017165854'}], 'facility': 'Jersey City Medical Center RWJ Barnabas Health', 'geoPoint': {'lat': 40.72816, 'lon': -74.07764}}, {'zip': '07039', 'city': 'Livingston', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Richard S. Yoon, MD', 'role': 'CONTACT', 'email': 'yoonrich@gmail.com', 'phone': '2017165847'}], 'facility': 'Saint Barnabas Medical Center Livingston', 'geoPoint': {'lat': 40.79593, 'lon': -74.31487}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William Obremskey, MD', 'role': 'CONTACT', 'email': 'William.Obremskey@vumc.org'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'An Sermon', 'role': 'CONTACT', 'email': 'an.sermon@uzleuven.be', 'phone': '+32 16 34 45 92'}], 'facility': 'Universitaire Ziekenhuiven Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Bogotá', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Saúl Leonardo Martínez Prieto, MD', 'role': 'CONTACT', 'email': 'smart7406@yahoo.com', 'phone': '573105616266'}], 'facility': 'Hospital Santa Clara', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marcel Niemann, MD', 'role': 'CONTACT', 'email': 'marcel.niemann@charite.de'}], 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Ludwigshafen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Paul Grützner, MD', 'role': 'CONTACT', 'email': 'Paul.Gruetzner@bgu-ludwigshafen.de', 'phone': '+49 62168102311'}], 'facility': 'BG-Unfallklinik Ludwigshafen', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'city': 'Münster', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael J. Raschke, MD', 'role': 'CONTACT', 'email': 'Michael.Raschke@uni-muenster.de', 'phone': '+49 251 4841 881'}], 'facility': 'Universitätsklinikum Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Palma de Mallorca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Angel Del Rio Mangada, MD', 'role': 'CONTACT', 'email': 'ario@hsll.es'}], 'facility': 'Hospital Universitario Son Llàtzer', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Dominik Bühler, Dr. med.', 'role': 'CONTACT', 'email': 'Dominik.Buehler@usb.ch'}], 'facility': 'Universitätsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '4410', 'city': 'Liestal', 'status': 'TERMINATED', 'country': 'Switzerland', 'facility': 'Kantonspital Baselland', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}, {'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Hans-Christoph Pape, MD', 'role': 'CONTACT', 'email': 'hans-christoph.pape@usz.ch'}], 'facility': 'Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Marco Minoia', 'role': 'CONTACT', 'email': 'marco.minoia@aofoundation.org', 'phone': '+41 79 612 09 67'}, {'name': 'Viola Grünenfelder', 'role': 'CONTACT', 'email': 'Viola.Gruenenfelder@aofoundation.org', 'phone': '+41 796963397'}], 'overallOfficials': [{'name': 'Karl Stoffel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsspital Basel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AO Innovation Translation Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}