Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT06309433
Status:
RECRUITING
Last Update Posted:
2025-03-14
First Post:
2024-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2024-01-13', 'studyFirstSubmitQcDate': '2024-03-06', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periprosthetic bone mineral density measurement', 'timeFrame': 'at baseline (day 0)', 'description': 'measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry'}, {'measure': 'Periprosthetic bone mineral density measurement', 'timeFrame': '6 months', 'description': 'measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry'}, {'measure': 'Periprosthetic bone mineral density measurement', 'timeFrame': '12 months', 'description': 'measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry'}, {'measure': 'Periprosthetic bone mineral density measurement', 'timeFrame': '24 months', 'description': 'measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry'}], 'secondaryOutcomes': [{'measure': 'Knee Society Score', 'timeFrame': 'at baseline (day 0)', 'description': "Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100"}, {'measure': 'Knee Society Score', 'timeFrame': '6 months', 'description': "Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100"}, {'measure': 'Knee Society Score', 'timeFrame': '12 months', 'description': "Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100"}, {'measure': 'Knee Society Score', 'timeFrame': '24 months', 'description': "Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100"}, {'measure': 'Western Ontario and McMaster Universities Arthritis Index', 'timeFrame': 'at baseline (day 0)', 'description': 'The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96'}, {'measure': 'Western Ontario and McMaster Universities Arthritis Index', 'timeFrame': '6 months', 'description': 'The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96'}, {'measure': 'Western Ontario and McMaster Universities Arthritis Index', 'timeFrame': '12 months', 'description': 'The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96'}, {'measure': 'Western Ontario and McMaster Universities Arthritis Index', 'timeFrame': '24 months', 'description': 'The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96'}, {'measure': 'Knee injury and Osteoarthritis Outcome Score', 'timeFrame': 'at baseline, (day 0)', 'description': 'The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living, Function in Sport and Recreation, and knee-related Quality of Life . the score goes from 0 to 100'}, {'measure': 'Knee injury and Osteoarthritis Outcome Score', 'timeFrame': '6 months', 'description': 'The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living , Function in Sport and Recreation , and knee-related Quality of Life . the score goes from 0 to 100'}, {'measure': 'Knee injury and Osteoarthritis Outcome Score', 'timeFrame': '12 months', 'description': 'The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living , Function in Sport and Recreation , and knee-related Quality of Life . the score goes from 0 to 100'}, {'measure': 'Knee injury and Osteoarthritis Outcome Score', 'timeFrame': '24 months', 'description': 'The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living , Function in Sport and Recreation , and knee-related Quality of Life . the score goes from 0 to 100'}, {'measure': '36-Item Short Form Health Survey', 'timeFrame': 'at baseline (day 0)', 'description': 'is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.'}, {'measure': '36-Item Short Form Health Survey', 'timeFrame': '6 months', 'description': 'is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.'}, {'measure': '36-Item Short Form Health Survey', 'timeFrame': '12 months', 'description': 'is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.'}, {'measure': '36-Item Short Form Health Survey', 'timeFrame': '24 months', 'description': 'is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periprosthetic Osteolysis']}, 'descriptionModule': {'briefSummary': 'compare changes in BMD via DXA at the level of the femoral and tibial periprosthetic bone between two groups of patients undergoing cemented TKA of different design (posterior stabilization vs posterior cruciate preservation) with proms at a 2-year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged ≥ 45 years\n2. Patients who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:\n\nto. Primary or secondary osteoarthritis b. Collagen disorders and/or avascular necrosis of the femoral condyle c. Moderate valgus, varus or flexion deformities (HKA within ±10°, flexion contracture \\<10°) 3. Patients consenting and able to complete planned study procedures and follow-up assessments 4. Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee.\n\nExclusion Criteria:\n\n1. Patients aged \\< 45 years;\n2. Patients who have already undergone hip or knee arthroplasty ankle, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases. In this way, homogeneity of the investigated cohort will be guaranteed;\n3. Pregnant women. -'}, 'identificationModule': {'nctId': 'NCT06309433', 'acronym': 'DXA-TKA', 'briefTitle': 'Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Assessment of Bone Mineral Density at the Interface With the Femoral and Tibial Components in Patients Undergoing Total Knee Prosthesis of Different Design and Material', 'orgStudyIdInfo': {'id': 'DXA-TKA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PS TKA', 'description': 'Patients with Posterior stabilized Total knee replacement', 'interventionNames': ['Diagnostic Test: dual energy x-ray absorptiometry']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CR TKA', 'description': 'Patients with cruciate retaining Total knee replacement', 'interventionNames': ['Diagnostic Test: dual energy x-ray absorptiometry']}], 'interventions': [{'name': 'dual energy x-ray absorptiometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patient will undergo periodic (6-12-24m) dexa scans on the periprosthetic bone', 'armGroupLabels': ['CR TKA', 'PS TKA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bologna', 'state': 'Italia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Zaffagnini, MD', 'role': 'CONTACT', 'email': 'stefano.zaffagnini@unibo.it', 'phone': '051 6366075'}], 'facility': 'Stefano Zaffagnini', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '40136', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Zaffagnini, Prof.', 'role': 'CONTACT', 'email': 'stefano.zaffagnini@unibo.it', 'phone': '00390516366111'}], 'facility': 'Istituto ortoepdico rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}