Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:26 PM
Study NCT ID:
NCT07481461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Altered Joint Mechanics and Biological Response in Osteoarthritic Knees.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D000077107', 'term': 'Gait Analysis'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D005684', 'term': 'Gait'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D000076604', 'term': 'Physical Functional Performance'}, {'id': 'D010809', 'term': 'Physical Fitness'}, {'id': 'D006262', 'term': 'Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is designed as a prospective interventional study without IMP. There will be no randomisation as the patients will undergo to the treatment (High tibial osteotomy (HTO) or braces) prescribed to them independently from the study. Patients will be recruited after the treatment has already been recommended by their ortopaedic surgeon, independently from the study purposes, and accepted by the patient. For this study we aim at enrolling 30 patients: 10 receiving HTO surgery and 20 braces therapy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone microstructure quantification', 'timeFrame': 'From enrollment to the end of study at 24 months', 'description': 'Trabecular morphology will be described with the bone volume fraction (BV/TV), trabecular thickness (Tb.Th), trabecular separation (Tb.Sp) and trabecular number (Tb.N).'}, {'measure': 'Mechanical properties in osteoarthritic knees', 'timeFrame': 'From enrollment to the end of study at 24 months', 'description': 'A PCCT-based finite element (FE) model will be built to estimate bone strength, stiffness and apparent modulus by simulating an axial compression.'}, {'measure': 'Load shift quantification', 'timeFrame': 'From enrollment to the end of study at 24 months', 'description': 'An FE model, simulating forces acting in the knee joint during physiological walking will be built, deriving such forces from gait analysis.'}], 'secondaryOutcomes': [{'measure': 'Proteoglycans quantification', 'timeFrame': 'From enrollment to the end of study at 24 months', 'description': 'As content of cartilage, proteoglycans will be quantified using a specific MRI sequence at pre-treatment and 12 and 24 months post-treatment. These measurements will be compared with the in silico models prediction through an agreement analysis.'}, {'measure': 'Collagen quantification', 'timeFrame': 'From enrollment to the end of study at 24 months', 'description': 'As content of cartilage, collagen will be quantified using a specific MRI sequence at pre-treatment and 12 and 24 months post-treatment. These measurements will be compared with the in silico models prediction through an agreement analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis (OA)']}, 'descriptionModule': {'briefSummary': 'Osteoarthritis (OA) stands out as the most prevalent joint disease. It manifests as a progressive degradation of articular cartilage, new bone growth and often synovial tissue proliferation, resulting in pain and compromised joint functionality, ultimately leading to disability. Misalignment of the lower limb (varus or valgus knees) are recognised as a risk factor for osteoarthritis onset and progression. High tibial osteotomy (HTO) is a surgical technique that allows to shift the load from the affected area to other areas with intact cartilage. Similarly to HTO, braces realign the lower limb, without the need for surgical intervention. These corrective treatments are recommended for the youngest group of patients as it allows them to stay active, as opposed to Total Knee Replacement (TKR). Until today, the effects of braces and HTO on the subchondral bone microstructure and cartilage are not well understood. Investigating these aspects to better understand treatment failures is becoming more and more crucial because global prevalence of knee OA is expected to increase with the ageing of populations.', 'detailedDescription': 'Osteoarthritis (OA) stands out as the most prevalent joint disease. It manifests as a progressive degradation of articular cartilage, new bone growth and often synovial tissue proliferation, resulting in pain and compromised joint functionality, ultimately leading to disability. In 83% of OA patients the knee is affected limiting people from engaging in physical activities, which paves the way for the onset of cardiovascular diseases, obesity, and diabetes. Misalignment of the lower limb (varus or valgus knees) are recognised as a risk factor for osteoarthritis onset and progression. These misalignments of the lower limbs substantially influence the load distribution across the articular surface of the knee joint, and the load imbalance causes the most loaded compartment to wear out earlier. High tibial osteotomy (HTO) is a surgical technique that allows to shift the load from the affected area to other areas with intact cartilage. Similarly to HTO, braces realign the lower limb, without the need for surgical intervention. These corrective treatments are recommended for the youngest group of patients as it allows them to stay active, as opposed to Total Knee Replacement (TKR). However, long-term survivorship of HTO ranges from 40% to 85% and evidence of long-term efficacy of braces is limited. The specific reasons for failure are not well understood, but are probably linked to improper correction, as overcorrection can lead to instability while undercorrection may fail to alleviate symptoms, and no consensus on the optimal amount exist in literature. Until today, the effects of braces and HTO on the subchondral bone microstructure and cartilage are not well understood. Investigating these aspects to better understand treatment failures is becoming more and more crucial because global prevalence of knee OA is expected to increase with the ageing of populations.\n\nBone remodelling occurs as a consequence of the major change in loading condition, caused by the treatments, but the time frame and the extent to which this happens is unknown. Bone quality is typically evaluated by means of dual-energy X-ray absorptiometry (DXA), which is able to detect 2D changes in bone mineral density, but not suitable to measure regional differences in bone microstructure. High resolution pheripheral quantitative CT (HR-pQCT) is a widespread imaging technique in research context. It allows for 3D measurements and it was proven that it can accurately quantify bone remodelling at the wrist. However, HR-pQCT has a low clinical applicability, due to long scanning time and small field of view, that does not allow imaging of central sites, such as the knee. Photon Counting CT (PCCT) is one of the latest advancements in CT technique, with resolution comparable to HR-pQCT but higher clinical applicability. It was shown that PCCT is suitable to detect bone turnover in the same way as HR-pQCT, allowing for direct characterization of the microstructure at the knee.\n\nDespite extensive in vitro and in vivo research, it remains unclear how the changes in cartilage composition and structure that occur during cartilage degeneration, interact. An in silico model to investigate the causal mechanisms by which the local mechanical environment of injured cartilage drives cartilage degeneration has been developed. The model predictions showed good agreement with previous experimental observations, however a more extensive validation with in vivo data would allow to investigate more physiological conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.\n* Chronic symptoms of (early) knee OA.\n* Misalignment of the lower limb and scheduled for HTO surgery (regardless of the HTO technique used (lateral or medial, closing or opening wedge)) or brace treatment.\n* Follow-up at UZ Leuven.\n\nExclusion Criteria:\n\n* Acute OA symptoms onset (previous knee injury)\n* Pregnant women\n* MRI checklist incomplete or failed\n* BMI \\> 30\n* Impaired vision or neurological condition that affect coordination and balance\n* Age \\<18 (no minors will be included in the study)'}, 'identificationModule': {'nctId': 'NCT07481461', 'acronym': 'AMB-OK', 'briefTitle': 'Altered Joint Mechanics and Biological Response in Osteoarthritic Knees.', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Altered Joint Mechanics and Biological Response in Osteoarthritic Knees. A Study in Patients Undergoing Corrective Treatment for Knee Misalignment.', 'orgStudyIdInfo': {'id': 'S70583'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High tibial osteotomy', 'description': 'High tibial osteotomy (HTO) is a surgical technique that allows to shift the load from the affected area to other areas with intact cartilage. This study aimes to include 10 patients receiveing HTO surgery.', 'interventionNames': ['Diagnostic Test: Photon counting CT scanning (PCCT scanning)', 'Diagnostic Test: Magnetic resonance imaging (MRI scanning)', 'Diagnostic Test: Gait analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Braces therapy', 'description': 'Braces realign the lower limb, this corrective treatments occures without the need for surgical intervention. This study aimes to include 20 patients in this treatment arm.', 'interventionNames': ['Diagnostic Test: Photon counting CT scanning (PCCT scanning)', 'Diagnostic Test: Magnetic resonance imaging (MRI scanning)', 'Diagnostic Test: Gait analysis']}], 'interventions': [{'name': 'Photon counting CT scanning (PCCT scanning)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Photon Counting CT (PCCT) is a novel imaging technique that allows for in vivo high-resolution imaging of the bone microstructure. It has a large field of view and short scanning time compared to the current gold standard for bone microstructural quantification, High Resolution-peripheral CT (HR-pQCT). PCCT scans are performed at pre-treatment visit, 6 months, 12 months and 24 months post-treatment.', 'armGroupLabels': ['Braces therapy', 'High tibial osteotomy']}, {'name': 'Magnetic resonance imaging (MRI scanning)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cartilage is typically imaged with MRI for its high content of water. Different MRI sequences allow to quantify anatomical aspects such as cartilage volume and thickness, but also its contents (proteoglycans and collagen). MRI scans are performed at pre-treatment visit, 12 months and 24 months post-treatment.', 'armGroupLabels': ['Braces therapy', 'High tibial osteotomy']}, {'name': 'Gait analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'The load shift after limb realignment will also be measured. Gait analysis (combined with musculoskeletal modelling) will be used to measure joint contact forces and knee joint geometry will be derived from the PCCT and MRI scans. Forces and geometry will be given as input to a Finite Element (FE) model of the knee joint, computing stresses and strains distribution on bone and cartilage. The gait analysis will be performed pre-treatment and 12 months post-treatment.', 'armGroupLabels': ['Braces therapy', 'High tibial osteotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'contacts': [{'name': 'Harry van Lenthe, Prof. Ir.', 'role': 'CONTACT', 'email': 'harry.vanlenthe@kuleuven.be', 'phone': '+32 16 32 25 95'}, {'name': 'Anna Tarasiuk', 'role': 'CONTACT', 'email': 'orthopedie.research@uzleuven.be', 'phone': '+32 16 33 88 18'}, {'name': 'Harry van Lenthe, Prof. Ir.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hilde Vandenneucker, Prof. Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universitaire Ziekenhuizen KU Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Harry van Lenthe, Prof. Ir.', 'role': 'CONTACT', 'email': 'harry.vanlenthe@kuleuven.be', 'phone': '+32 16 32 25 95'}, {'name': 'Anna Tarasiuk', 'role': 'CONTACT', 'email': 'orthopedie.research@uzleuven.be', 'phone': '+32 16 33 88 18'}], 'overallOfficials': [{'name': 'Harry van Lenthe, Prof. Ir.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}