Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT05825456
Status:
RECRUITING
Last Update Posted:
2025-03-05
First Post:
2023-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metastatic Pathologic Fractures, Short Term Results
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005598', 'term': 'Fractures, Spontaneous'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005594', 'term': 'Fracture Fixation, Intramedullary'}, {'id': 'D001860', 'term': 'Bone Plates'}], 'ancestors': [{'id': 'D005593', 'term': 'Fracture Fixation, Internal'}, {'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016268', 'term': 'Internal Fixators'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-01', 'studyFirstSubmitDate': '2023-03-26', 'studyFirstSubmitQcDate': '2023-04-11', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Musculoskeletal Tumor Society (MSTS) score', 'timeFrame': 'Preoperative', 'description': 'MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.'}, {'measure': 'Musculoskeletal Tumor Society (MSTS) score', 'timeFrame': 'Postoperative 1st day', 'description': 'MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.'}, {'measure': 'Musculoskeletal Tumor Society (MSTS) score', 'timeFrame': 'Postoperative 1st week', 'description': 'MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.'}, {'measure': 'Musculoskeletal Tumor Society (MSTS) score', 'timeFrame': 'Postoperative 1st month', 'description': 'MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.'}, {'measure': 'Toronto Extremity Salvage Score (TESS)', 'timeFrame': 'Preoperative', 'description': 'TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.'}, {'measure': 'Toronto Extremity Salvage Score (TESS)', 'timeFrame': 'Postoperative 1st day', 'description': 'TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.'}, {'measure': 'Toronto Extremity Salvage Score (TESS)', 'timeFrame': 'Postoperative 1st week', 'description': 'TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.'}, {'measure': 'Toronto Extremity Salvage Score (TESS)', 'timeFrame': 'Postoperative 1st month', 'description': 'TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.'}, {'measure': 'Visual analog scale (VAS)', 'timeFrame': 'Preoperative', 'description': 'VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.'}, {'measure': 'Visual analog scale (VAS)', 'timeFrame': 'Postoperative 1st day', 'description': 'VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.'}, {'measure': 'Visual analog scale (VAS)', 'timeFrame': 'Postoperative 1st week', 'description': 'VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.'}, {'measure': 'Visual analog scale (VAS)', 'timeFrame': 'Postoperative 1st month', 'description': 'VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.'}, {'measure': 'Upper Extremity Functional Scale (UEFS)', 'timeFrame': 'Preoperative', 'description': 'UEFS is a functional scale for upper extremity. It is not specific for tumor patients.'}, {'measure': 'Upper Extremity Functional Scale (UEFS)', 'timeFrame': 'Postoperative 1st day', 'description': 'UEFS is a functional scale for upper extremity. It is not specific for tumor patients.'}, {'measure': 'Upper Extremity Functional Scale (UEFS)', 'timeFrame': 'Postoperative 1st week', 'description': 'UEFS is a functional scale for upper extremity. It is not specific for tumor patients.'}, {'measure': 'Upper Extremity Functional Scale (UEFS)', 'timeFrame': 'Postoperative 1st month', 'description': 'UEFS is a functional scale for upper extremity. It is not specific for tumor patients.'}, {'measure': 'Disabilities of Arm, Shoulder and Hand (DASH)', 'timeFrame': 'Preoperative', 'description': 'DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.'}, {'measure': 'Disabilities of Arm, Shoulder and Hand (DASH)', 'timeFrame': 'Postoperative 1st day', 'description': 'DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.'}, {'measure': 'Disabilities of Arm, Shoulder and Hand (DASH)', 'timeFrame': 'Postoperative 1st week', 'description': 'DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.'}, {'measure': 'Disabilities of Arm, Shoulder and Hand (DASH)', 'timeFrame': 'Postoperative 1st month', 'description': 'DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.'}, {'measure': 'Lower Extremity Functional Scale (LEFS)', 'timeFrame': 'Preoperative', 'description': 'LEFS is a functional scale for lower extremity. It is not specific for tumor patients.'}, {'measure': 'Lower Extremity Functional Scale (LEFS)', 'timeFrame': 'Postoperative 1st day', 'description': 'LEFS is a functional scale for lower extremity. It is not specific for tumor patients.'}, {'measure': 'Lower Extremity Functional Scale (LEFS)', 'timeFrame': 'Postoperative 1st week', 'description': 'LEFS is a functional scale for lower extremity. It is not specific for tumor patients.'}, {'measure': 'Lower Extremity Functional Scale (LEFS)', 'timeFrame': 'Postoperative 1st month', 'description': 'LEFS is a functional scale for lower extremity. It is not specific for tumor patients.'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': 'Preoperative', 'description': 'WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': 'Postoperative 1st day', 'description': 'WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': 'Postoperative 1st week', 'description': 'WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': 'Postoperative 1st month', 'description': 'WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.'}], 'secondaryOutcomes': [{'measure': 'Days at hospital after surgery', 'timeFrame': 'up to 1 month', 'description': 'Hospitalization length required after the surgery.'}, {'measure': 'Survival', 'timeFrame': 'up to 3 months', 'description': 'Time that the patient lives after the surgery'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bone metastasis', 'pathologic fracture', 'endoprosthetic reconstruction', 'intramedullary nailing', 'open reduction internal fixation', 'plate and screws'], 'conditions': ['Pathologic Fracture', 'Bone Metastases', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'This is a single center prospective study to compare the short term results of prosthesis, nail and plate-screw surgeries for metastatic pathologic fractures.', 'detailedDescription': 'The most common bone tumor in elderly is metastatic bone tumors. With the prolonged life expectancy in cancer patients, the management of the metastases became an essential topic.\n\nPathological fractures should be examined and managed with a different perspective. They usually cannot be healed by conservative methods and require surgical intervention. The primary goals of surgical intervention are to relieve pain and mobilize the patient as soon as possible.\n\nThe aim of the study is to compare the short-term functional endoprosthetic recontruction, intramedullary nailing and open reduction internal fixation.\n\nThe primary tumor of the patient, applied chemotherapy and radiotherapy, Mirel risk score, Charlson comorbidity index, and PathFx 3.0 survival will be evaluated preoperatively.\n\nThe type of the operation will be decided at the multidisciplinary tumor council of ankara University.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population includes patients with metastatic pathologic fractures treated via endoprosthesis, intramedullay nail or plate \\& screws.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* metastatic pathologic fracture\n* operated via endoprosthesis, intramedullary nail or plate \\& screws\n\nExclusion Criteria:\n\n* primary bone tumor\n* conservative management\n* neuromuscular disease\n* periprosthetic fractures\n* less than 1 month follow up'}, 'identificationModule': {'nctId': 'NCT05825456', 'briefTitle': 'Metastatic Pathologic Fractures, Short Term Results', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Metastatic Pathologic Fractures: Short Term Results of Endoprosthetic Reconstruction, Intramedullary Nail and Open Reduction Internal Fixation', 'orgStudyIdInfo': {'id': 'AnkaraUniOrtho'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'endoprosthetic reconstruction', 'description': 'This is the group of patients with metastatic pathologic fractures treated with endoprosthesis. For example, proximal femur prosthesis for femoral neck fractures.', 'interventionNames': ['Procedure: endoprosthetic reconstruction']}, {'label': 'intramedullary nail', 'description': 'This is the group of patients with metastatic pathologic fractures treated with intramedullary nail, and additional bone cement if needed. For example, proximal femur nail for trochanteric fractures, or long femoral nail for femoral shaft fractures.', 'interventionNames': ['Procedure: Intramedullary nailing']}, {'label': 'open reduction internal fixation with plate and screws', 'description': 'This is the group of patients with metastatic pathologic fractures treated with open reduction internal fixation; with plates and screws. For example, reconstruction plates for pelvic fractures or 3.5 locking compression plates for humeral or femur shaft fractures.', 'interventionNames': ['Procedure: Open reduction internal fixation with plate and screws']}], 'interventions': [{'name': 'endoprosthetic reconstruction', 'type': 'PROCEDURE', 'description': 'This is a type of surgery in which the affected part of the bone and joint is removed, and replaced by a prosthesis.', 'armGroupLabels': ['endoprosthetic reconstruction']}, {'name': 'Intramedullary nailing', 'type': 'PROCEDURE', 'description': 'This is a type of surgery in which the affected bone is stabilized by a nail. The affected part could be removed or retained. If removed, the defect is filled with bone cement.', 'armGroupLabels': ['intramedullary nail']}, {'name': 'Open reduction internal fixation with plate and screws', 'type': 'PROCEDURE', 'description': 'This is a type of surgery in which the affected part of the bone is visualized completely, after the reduction is achieved, the fixation is provided with appropriate plates and screws. Again the affected part could be removed or retained. If removed, the defect is filled with bone cement.', 'armGroupLabels': ['open reduction internal fixation with plate and screws']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06230', 'city': 'Ankara', 'state': 'altindag', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Merve Dursun Savran, MD', 'role': 'CONTACT', 'email': 'merve8dursun@gmail.com', 'phone': '00905395571557'}, {'name': 'Mustafa Onur Karaca, Assc. Proff', 'role': 'CONTACT', 'email': 'karaca_onur@yahoo.com', 'phone': '00905324812113'}, {'name': 'Merve Dursun Savran, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mustafa Onur Karaca, Assc. Proff', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ankara University Medical Faculty', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Final MSTS, TESS, UEFS, LEFS, DASH, WOMAC, VAS will be shared when the study is completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Merve Dursun Savran, MD', 'investigatorAffiliation': 'Ankara University'}}}}