[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"soft-tissue-defect\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:soft-tissue-defect":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100599075","truelok-elevate-pmcf-study-100599075",false,"NCT07079774","TrueLok Elevate PMCF Study","Post-Market Clinical Follow-up Study of the TrueLok Elevate Transverse Bone Transport System for the Treatment of Lower Limb Ulcers as Soft Tissue Defects","Inclusion Criteria:\n\nAged 18 years or older at the time of surgery Willing and able to sign and date the study-specific informed consent form in accordance with national and institutional ethics requirements Willing and able to comply with requirements of the protocol, including follow-up requirements Indicated for surgical intervention using the TrueLok Elevate Transverse Bone Transport System for the treatment of soft tissue defects in the form of lower limb ulcers\n\nPresence of a chronic ulcer, defined as:\n\n* Present for at least 3 months, and\n* Unresponsive to standard non-surgical or surgical wound management, including but not limited to debridement, negative pressure wound therapy (VAC), offloading, antibiotics, or vascular optimisation\n\nExclusion Criteria:\n\nMental or cognitive impairment or physiological or behavioural conditions that, in the opinion of the investigator, would preclude reliable adherence to postoperative care instructions, follow-up assessments, or study procedures\n\nKnown or presenting with the following signs of a systemic inflammatory response syndrome (SIRS) as exhibiting two or more of the following conditions:\n\no\n\n* Heart rate \\>90 beats\u002Fmin\n* Respiratory rate \\>20 breaths\u002Fmin\n* PaCO2 \\\u003C32-mm Hg\n* White blood cell count \\>12.000 or \\\u003C4.000\u002Fcu mm\n* 10% immature (band) forms Known hypersensitivity or allergy to any material used in the TrueLok Elevate Transverse Bone Transport System (e.g., stainless steel, titanium) Current participation in another interventional clinical study that, in the opinion of the investigator, may interfere with the objectives or outcomes of this study Presence of active malignancy or systemic infection that, in the investigator's opinion, may interfere with wound healing or the study protocol Life expectancy of less than 12 months Simultaneous bilateral application of the TrueLok Elevate Transverse Bone Transport System Current incarceration at the time of enrolment Any condition or clinical circumstance that, in the opinion of the investigator, would make participation not in the best interest of the subject or would interfere with the study objectives","ALL","18 Years",{"count":19,"type":20},153,"ESTIMATED","OBSERVATIONAL","The TrueLok Elevate Transverse Bone Transport System is a modular external fixation device designed for transverse bone transport. It promotes local vascular and wound healing through controlled corticotomy and gradual distraction. The system is intended for adult patients with bony and\u002For soft tissuedefects.",[24,25,26],"Wound of Skin","Ulcers","Soft Tissue Defect","RECRUITING","2026-03-31",{"date":30,"type":31},"2026-04-01","ACTUAL",{"date":33,"type":31},"2025-11-24",{"date":35,"type":20},"2028-11-24",{"name":37,"class":38},"Orthofix s.r.l.","INDUSTRY",5,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100590543","buccal-fat-pad-vs-palatal-rotation-scarf-grafts-for-soft-tissue-management-around-zygomatic-implants-100590543","NCT06968780","Buccal Fat Pad vs. Palatal Rotation Scarf Grafts for Soft Tissue Management Around Zygomatic Implants","Buccal Pad of Fat Graft vs. Palatal Rotation Scarf Graft for Soft Tissue Enhancement and Prevention of Dehiscence Around Zygomatic Implants Placed in Patients With Severely Atrophic Maxilla: A Randomized Clinical Trial","RCT BFP ZAGA","Inclusion Criteria:\n\n1. Patient of age 18 years or more, who can understand and sign an informed consent.\n2. Patients with severely atrophic edentulous upper arch (Cawood \\& Howell class IV, V, VI) that could not be restored by standard axial implants without augmentation.\n3. Patients with severely atrophic edentulous upper arch (Bedrossian classification inadequate bone in zones II or III or all three zones) that could not be restored by standard axial implants without augmentation.\n4. Good systemic health (ASA score I-II)\n5. Highly motivated patients with good compliance to oral hygiene habits.\n\nExclusion Criteria:\n\n1. Patients with cardiovascular disease or pulmonary disease or medical systemic condition that does not permit the surgical procedure under general anesthesia (ASA III, IV, V and VI).\n2. Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).\n3. Heavy smokers. (\\> 20 cigarettes daily)\n4. Patient with psychiatric problems, severe bruxism, or other parafunctional habits.\n5. Acute maxillary sinus infection or untreated maxillary sinus cyst.\n6. Malignancy or pathology in Maxilla or Zygoma.",{"count":49,"type":20},8,"INTERVENTIONAL",[52],"NA","Over the past 20 years, the demand for oral rehabilitation among edentulous patients has steadily increased. Traditionally, individuals with edentulous maxillae were treated using removable complete dentures. However, these often result in poor patient satisfaction due to instability and functional limitations. Dental rehabilitation with implants in the maxillary arch presents unique challenges, primarily due to the anatomical complexity of the maxilla and the need for adequate residual ridge dimensions for successful implant placement.\n\nFollowing the extraction of maxillary teeth, patients experience rapid and progressive alveolar bone loss in both vertical and horizontal dimensions. This resorption is largely attributed to the absence of teeth and periodontal ligament fibers support, which are essential for transmitting mechanical forces that maintain bone homeostasis. In addition, the loss of maxillary molars accelerates pneumatization\u002Fexpansion of the maxillary sinus, further reducing available bone volume. Contributing factors such as ill-fitting dentures and systemic health conditions can exacerbate this process, complicating implant placement even further.\n\nTo overcome these limitations, oral and maxillofacial surgeons have developed a range of advanced techniques, including tilted implants, sinus floor elevation, short implants, pterygoid implants, and most notably, zygomatic implants. Zygomatic implants bypass the atrophic alveolar ridge entirely by anchoring into the dense zygomatic bone, offering a reliable solution for patients with severely resorbed maxillae who are not candidates for conventional implant therapy.",[55,56,26,57],"Zygomatic Implants","Atrophic Maxilla","Soft Tissue Healing",[59,55,60,61,62,63,64,56,65,66,67,68,69],"ZAGA","Buccal Fat Pad","BFP","Palatal Rotation Graft","PRG","Scarf Graft","Soft tissue Recession","Dehiscence","RCT","Zygoma","Implant","2025-12-06",{"date":72,"type":31},"2025-12-12",{"date":74,"type":31},"2025-06-01",{"date":76,"type":20},"2026-12-01",{"name":78,"class":79},"Cairo University","OTHER",1]