Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:38 PM
Study NCT ID:
NCT07493733
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MPTA on Full Standing and Rosenberg Views in Patients Undergoing High Tibial Osteotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 49}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-21', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-21', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in medial proximal tibial angle (MPTA) measurments in both the Rosenberg view and full-leg standing radiographic position', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Medial Proximal Tibial Angle']}, 'referencesModule': {'references': [{'pmid': '1955438', 'type': 'BACKGROUND', 'citation': 'Ogata K, Yoshii I, Kawamura H, Miura H, Arizono T, Sugioka Y. Standing radiographs cannot determine the correction in high tibial osteotomy. J Bone Joint Surg Br. 1991 Nov;73(6):927-31. doi: 10.1302/0301-620X.73B6.1955438.'}, {'type': 'BACKGROUND', 'citation': '[9] Deep K, Eachempati KK, Apsingi S. The dynamic nature of alignment and variations in normal knees. Bone Joint Lett J 2015;97-B(4):498-502. https://doi.org/ 10.1302/0301-620X.97B4.33740.'}, {'pmid': '37839705', 'type': 'BACKGROUND', 'citation': 'Palmer J, Getgood A, Lobenhoffer P, Nakamura R, Monk P. Medial opening wedge high tibial osteotomy for the treatment of medial unicompartmental knee osteoarthritis: A state-of-the-art review. J ISAKOS. 2024 Feb;9(1):39-52. doi: 10.1016/j.jisako.2023.10.004. Epub 2023 Oct 13.'}, {'type': 'BACKGROUND', 'citation': '[7] Dugdale TW, Noyes FR, Styer D. Preoperative planning for high tibial osteotomy. The effect of lateral tibiofemoral separation and tibiofemoral length. Clin Orthop Relat Res 1992;274:248-64.'}, {'type': 'BACKGROUND', 'citation': '[6] Yasuda K, Majima T, Tsuchida T, Kaneda K. A ten- to 15-year follow-up observation of high tibial osteotomy in medial compartment osteoarthrosis. Clin Orthop Relat Res 1992;282:186-95.'}, {'type': 'BACKGROUND', 'citation': '[5] Hernigou P, Medevielle D, Debeyre J, Goutallier D. Proximal tibial osteotomy for osteoarthritis with varus deformity. A ten to thirteen-year follow-up study. J Bone Joint Surg Am 1987;69(3):332-54.'}, {'pmid': '8423180', 'type': 'BACKGROUND', 'citation': 'Coventry MB, Ilstrup DM, Wallrichs SL. Proximal tibial osteotomy. A critical long-term study of eighty-seven cases. J Bone Joint Surg Am. 1993 Feb;75(2):196-201. doi: 10.2106/00004623-199302000-00006.'}, {'pmid': '14318636', 'type': 'BACKGROUND', 'citation': 'COVENTRY MB. OSTEOTOMY OF THE UPPER PORTION OF THE TIBIA FOR DEGENERATIVE ARTHRITIS OF THE KNEE. A PRELIMINARY REPORT. J Bone Joint Surg Am. 1965 Jul;47:984-90. No abstract available.'}, {'type': 'BACKGROUND', 'citation': '[1] Ayet CAB, Mancino F, Lim YP, Qian K, Jacob G, Parker DA. Satisfactory 10-year survivorship of medial opening wedge high tibial osteotomy for isolated medial compartment osteoarthritis and varus alignment: an analysis from a high-volume institution. Knee Surg Sports Traumatol Arthrosc 2025 May;33(5):1804-14. https://doi.org/10.1002/ksa.12633. Published online February 20.'}, {'pmid': '39290201', 'type': 'BACKGROUND', 'citation': 'Gkekas NK, Komnos GA, Mylonas T, Chalatsis G, Koutalos AA, Hantes ME. Medial open wedge high tibial osteotomy is a viable option in young patients with advanced arthritis in a long-term follow-up. Knee Surg Sports Traumatol Arthrosc. 2025 Mar;33(3):1025-1032. doi: 10.1002/ksa.12469. Epub 2024 Sep 18.'}]}, 'descriptionModule': {'briefSummary': '-Comparison of MPTA on both Full-leg Standing and Rosenberg Radiographs .', 'detailedDescription': 'The medial open wedge high tibial osteotomy (MOW-HTO) is awidely and successfully performed treatment for medial compartment osteoarthritis (OA) of the knee joint .\n\nThe primary goal of MOW-HTO is to alleviate mechanical stress onthe medial compartment of the knee joint by shifting the weight-bearing line (WBL) toward the lateral compartment .\n\nCorrect alignment is essential for achieving long-term success and favorable outcomes, making accurate preoperative planning crucial.\n\nAccepted gold standard for preoperative coronal plane assessment of lower limb alignment are full-leg standing radiographs (FLSR) .\n\nMeasurement variables in the coronal plane include the mechanical lateral proximal femoral angle (mLPFA), mechanical lateral distal femoral angle (mLDFA), mechanical medial proximal tibial angle and mechanical lateral distal tibial angle.\n\nHowever, alignment measurements are influenced by factors such as knee flexion, rotation, and loading conditions .\n\nIdentifying these factors prior to surgery is crucial to minimizing the risk of surgical error.\n\nPosteroanterior weight-bearing radiographs taken with the knee in 45 degrees of flexion, commonly referred to as the Rosenberg view (RB), are routinely used preoperatively . This imaging technique not only facilitates the assessment of the severity of knee OA but also aids in evaluating the degree of soft tissue laxity contributing to varus alignment-a factor increasingly recognized for its clinical significance .\n\nFor knowledge, one study has investigated how knee alignment parameters used for planning of HTO differ when measured using the RB .\n\nThe invistegator hypothesize that the medial proximal tibial angle (MPTA) does not differ when measured on RB radiographs compared with FLSR. Being a widely accessible and commonly used imaging technique, if confirmed, this finding would suggest that the RB could serve as a com-plementary modality for preoperative planning for MOW-HTO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatient clinics and inpatient ward of Orthopedics \\& Trauma Surgery Department , Asyut University Hospitals , Faculty of Medicine', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients were screened for medial compartment OA of either the left or right knee joint.\n* Availability of preoperative full-length standing radiograph and Rosenberg view.\n* Completeness of patient records .\n* Patient consent\n\nExclusion Criteria:\n\n* Insufficient patient records .\n* Previous ligamentous surgery or osteotomies .\n* Known neuromuscular or metabolic disorder .\n* Absence of a radiographic reference ball.'}, 'identificationModule': {'nctId': 'NCT07493733', 'briefTitle': 'MPTA on Full Standing and Rosenberg Views in Patients Undergoing High Tibial Osteotomy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparing Medial Proximal Tibial Angle Measurements on Full-leg Standing Radiographs and The Rosenberg View in Patients Undergoing High Tibial Osteotomy', 'orgStudyIdInfo': {'id': 'Comparison of MPTA in two view'}}, 'armsInterventionsModule': {'interventions': [{'name': 'X-ray', 'type': 'DEVICE', 'description': 'comparing of MPTA on full standing and rosenberg views'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Gadelkarem Farrag, Resident Doctor', 'role': 'CONTACT', 'email': 'agad6126@gmail.com', 'phone': '+20 01009372187'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Invistegator', 'investigatorFullName': 'Ahmed Gad Elkariem Farrag', 'investigatorAffiliation': 'Assiut University'}}}}