[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"augmentation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:augmentation":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,70,95],{"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},"100589894","long-term-clinical-outcome-after-arthroscopic-rotator-cuff-repair-augmentation-with-autologous-microfragmented-lipoaspirate-tissue-100589894",false,"NCT06960343","Long Term Clinical Outcome After Arthroscopic Rotator Cuff Repair Augmentation With Autologous Microfragmented Lipoaspirate Tissue","Long Term Clinical Outcome After Arthroscopic Rotator Cuff Repair Augmentation With Autologous Microfragmented Lipoaspirate Tissue: a Prospective Randomized Controlled Trialin Question Won by Our Research Group.","Inclusion Criteria:\n\n* Age \\> 18 years\n* Full-thickness supraspinatus and infraspinatus tendon tears (C1, C2, and C3 according to the SCOI classification)\n* Indication for arthroscopic rotator cuff repair\n* Informed consent to participate in the study\n* Informed consent to participate for the duration of the study\n\nExclusion Criteria:\n\n* Partial rotator cuff tendon tears (A1, A2, A3, B1, B2, and B3 according to the SCOI classification)\n* Massive rotator cuff tear (C4 according to the SCOI classification)\n* Subscapularis tendon tear (grade III, IV, or IV according to Lafosse classification)\n* Associated anterior, posterior, or multidirectional shoulder instability\n* Indication for repair of a SLAP lesion of the biceps anchor\n* Grade III or IV muscle atrophy of the supraspinatus and infraspinatus tendons (according to Goutallier or Fuchs classification)\n* Intra-articular hyaluronic acid or corticosteroid infiltration within 3 mo from the planned surgical procedure\n* Medical comorbidities contraindicating arthroscopic shoulder surgery\n* Local (shoulder, abdominal region, gluteal region) or systemic infection, osteomyelitis, or sepsis\n* Diabetes mellitus, untreated thyroid disease, chronic kidney disease, rheumatoid arthritis\n* Immunodeficiency\n* Chronic disorders involving coagulation, platelet aggregation, or severe coagulopathy\n* Severe cardiovascular disease\n* Stroke or acute cardiovascular event within 6 mo from the planned surgical procedure\n* Weight loss for any cause .30 kg in 12 mo or .10 kg in 12 mo without a cause\n* Eating disorders or body dysmorphic disorder\n* Varices, phlebitis, or scars next to the planned adipose tissue harvesting site\n* Alcohol\u002Fdrug addiction or psychiatric disease compromising compliance with postoperative protocols\n* Pregnancy or breastfeeding women\n* Informed consent not accepted","ALL","18 Years",{"count":19,"type":20},52,"ESTIMATED","OBSERVATIONAL","Specific Aims :\n\nThe aim of this prospective randomized controlled single-blind clinical trial was to evaluate the safety and efficacy of autologous microfragmented lipoaspirate tissue in arthroscopic rotator cuff repair.\n\nThe primary goal of this study was to test the following hypothesis: an intraoperative injection of autologous microfragmented adipose tissue processed with an enzyme-free technology could improve the clinical outcomes of single-row arthroscopic rotator cuff repair in terms of points in the Constant-Murley score (CMS) collected at least 5 years after surgery.\n\nBackground and Significance:\n\nRotator cuff surgery was initially proposed at the end of the 19th century and evolved then from open to arthroscopic techniques, rising quickly from a minor niche to a fully recognized subspecialty.\n\nTo improve clinical and functional results and reduce the retear rate, new fixation techniques and biological solutions to enhance tendon healing are being developed at a fast pace, as shown by the dramatic increase in the number of articles published per year.\n\nBiological solutions to enhance rotator cuff healing include growth factors and platelet-rich plasma, as well as mesenchymal stem cells (MSCs) and their derivatives.\n\nMSCs are believed to enhance tissue healing mainly through stimulation of local cells via paracrine mechanisms and anti-inflammatory and\u002For immunomodulatory activity, thus creating a suitable microenvironment for tissue repair.\n\nAutologous microfragmented lipoaspirate tissue has been recently introduced in orthopaedics as an easily available source of adipose derived MSCs (ADSCs) to support and accelerate tissue regeneration. Lipoaspirates contain human ADSCs and produce growth factors, such as platelet-derived growth factor, fibroblast growth factor, transforming growth factor beta, and vascular endothelial growth factor, which play important regulatory roles in cellular functions, including adhesion, chemotaxis, proliferation, migration, matrix synthesis, differentiation, and angiogenesis.\n\nHerewith, autologous microfragmented lipoaspirate tissue is expected to optimize the microenvironment for tendon regeneration. Among many approaches, devices relying on nonenzymatic methods and avoiding the use of additives and other additional manipulations (eg, centrifugation) allow one to harvest, process, and obtain autologous microfragmented lipoaspirate tissue directly in the operative theatre under sterile conditions. This permits immediate use in the same surgical intervention without delays owing to the difficulty of an ex vivo cell expansion and the complexity of the current good manufacturing practice requirements for preparing cells for therapeutic use.\n\nAlthough several animal studies have been published showing promising results for the use of ADSCs in enhancing the healing of rotator cuff tears, minimal evidence describing augmentation of rotator cuff treatment with lipoaspirate.\n\nPreliminary Studies\u002FProgress Report:\n\nThis study is a prospective, randomized, double-blind, controlled clinical trial and represents the final follow-up of an our previous study with short follow-up (2 years). The previous study demonstrated that the intraoperative injection of autologous microfragmented adipose tissue is safe and effective in improving short-term clinical and functional results after single-row arthroscopic rotator cuff repair.\n\nNevertheless, no significant differences emerged between the groups in terms of rerupture rate, complication rate, number of adverse events, and mid-term clinical outcomes.\n\nA previous in vitro study showed that autologous microfragmented adipose tissue significantly increases the proliferation rate of human tendon stem cells without altering their stemness and differentiation capability. Moreover, treated cells increase the expression of VEGF, which is crucial for the neovascularization of the tissue during the healing process.\n\nResearch Design and Method:\n\nAt least 5 years after surgery, all enrolled patients in the previous study will be call again and will be asked to complete the ASES, SST, and VAS questionnaire and they will undergo a clinical examination, including the CMS and measurement of isometric strength in shoulder forward flexion, abduction, and external rotation. All strength measures will be performed in triplicate with a dynamometer.\n\nDuring the same assessment day, the patients would be evaluated with MRI of the operated shoulder in order to assess tendon integrity and calculate rerupture rate according to the classification proposed by Sugaya (types IV and V defined as retears). Atrophy of the supraspinatus muscle belly was evaluated according to Warner and fatty degeneration was classified according to Fuchs.",[24,25,26],"Arthroscopic Rotator Cuff Repair","Augmentation","Microfragmented Adipose Tissue","RECRUITING","2026-04-27",{"date":30,"type":31},"2026-04-28","ACTUAL",{"date":33,"type":31},"2025-04-11",{"date":35,"type":20},"2026-10-11",{"name":37,"class":38},"University of Milan","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":39},"100598686","penile-skin-versus-buccal-mucosal-graft-in-augmentation-urethroplasty-for-long-anterior-urethral-stricture-100598686","NCT07074717","Penile Skin Versus Buccal Mucosal Graft in Augmentation Urethroplasty for Long Anterior Urethral Stricture","Penile Skin Versus Buccal Mucosal Graft in Augmentation Urethroplasty for Long Anterior Urethral Stricture: A Prospective Randomized Study","Inclusion Criteria:\n\n* Patients with long segment anterior urethral stricture that was defined as a stricture with a length of more than 1 cm with spongiofibrosis.\n* Patients with previous failed urethral dilatation or direct vision internal urethrotomy (DVIU)\n\nExclusion Criteria:\n\n* Patients with lichen sclerosus\n* Patients with history of hypospadias repair\n* Patients with recurrent urethral stricture after failed previous urethroplasty","MALE","18 Months",{"count":50,"type":20},80,"INTERVENTIONAL",[53],"NA","The aim of this study is to analyze the outcomes of dorsal onlay buccal mucosal graft (BMG) and penile skin graft (PSG) urethroplasty in the management of long segment bulbar urethral stricture.",[56,57,25,58,59,60],"Penile Skin","Buccal Mucosal Graft","Urethroplasty","Long Anterior","Urethral Stricture","2025-07-10",{"date":63,"type":31},"2025-07-20",{"date":65,"type":31},"2025-01-01",{"date":67,"type":20},"2025-12-01",{"name":69,"class":38},"Tanta University",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":77,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":51,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":39},"100576005","regional-anesthesia-techniques-in-breast-surgery-100576005","NCT06779656","Regional Anesthesia Techniques in Breast Surgery","Regional Anesthesia Techniques in Breast Surgery: a Comparative Study","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status classification I-III.\n* Age of 18 years or older.\n* Scheduled to undergo breast surgery, including augmentation, fibroadenoma excision, or mastectomy.\n\nExclusion Criteria:\n\n* Known allergy to local anesthetics.\n* Pregnancy or lactation.\n* Coagulation disorders.\n* Severe cardiopulmonary disease.\n* Local infection at the injection site.\n* Unstable psychiatric illness.","FEMALE",{"count":79,"type":20},180,[53],"This clinical trial aims to evaluate the efficacy of liposomal bupivacaine and ropivacaine, when administered via paravertebral block, the rhomboid intercostal and subserratus plane (RISS) block, PECS II block, intercostal nerve block, serratus anterior plane block, or epidural block, in patients undergoing breast surgery (including augmentation, fibroadenoma excision, and mastectomy). The primary objectives are to determine:\n\n1. Whether the use of liposomal bupivacaine or ropivacaine reduces the postoperative analgesic requirements in participants.\n2. What potential adverse events participants experience when using liposomal bupivacaine or ropivacaine.\n3. Which of the following regional anesthesia techniques provides superior analgesia: paravertebral block, RISS block, PECS II block, intercostal nerve block, serratus anterior plane block, or epidural block.\n\nParticipants will undergo one of the following regional anesthesia techniques upon arrival to the surgical suite: paravertebral block, RISS block, PECS II block, intercostal nerve block, serratus anterior plane block, or epidural block. Following regional anesthesia administration, general anesthesia with endotracheal intubation will be performed. Participants' vital signs, postoperative analgesic consumption, and recovery will be recorded.",[25,83,84],"Fibroadenoma","Mastectomy","NOT_YET_RECRUITING","2025-01-16",{"date":88,"type":31},"2025-01-17",{"date":90,"type":20},"2025-02-01",{"date":92,"type":20},"2025-05-10",{"name":94,"class":38},"Xiaguang Duan",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":16,"minAge":17,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":51,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100557914","phase-3-buttock-augmentation-with-polymethylmethacrylate-100557914","NCT06544304","Buttock Augmentation With Polymethylmethacrylate","Interventional, Multicenter, Single-Arm Clinical Trial of Buttock Augmentation With Polymethylmethacrylate","Inclusion Criteria:\n\n* Age between 18 and 60 years old;\n* Signed Informed Consent Form (ICF);\n* Participant understands and is willing to participate in the clinical study and attend visits.\n\nExclusion Criteria:\n\n* Known history of allergy to formula components;\n* Have the following morbidities (or any other disease that may interfere with the study): chronic inflammatory disease, immunosuppression, diabetes, hypertension, autoimmune disease, dermatological disease in the region to be treated, acute or chronic renal failure, history of coronary disease, history of cerebrovascular disease, current neoplasia, mental illness undergoing psychiatric treatment, obesity with a BMI above 30, asthma, bronchitis, seizures, hepatitis or other active infectious diseases;\n* Pregnancy;\n* Prior filling of glutes;\n* Use of acetylsalicylic acid, anti-inflammatories, anticoagulants, in the fifteen days before the procedure.\n* Vitamin D supplementation, with normal serum levels and which you do not agree to suspend;\n* Use of anabolic hormones;\n* Vitamin D (25 hydroxyvitamin D) greater than 70 ng\u002FmL;\n* Serum calcium greater than 10 mg\u002FdL;\n* Patients with total body PMMA volume of 650mL or more.",true,"60 Years",{"count":105,"type":20},133,[107],"PHASE3","Single-arm multicenter interventional clinical trial of buttock augmentation with polymethyl methacrylate.\n\nThe objective is to evaluate the safety and effectiveness of using 30% Biosimetric PMMA gel for buttock augmentation.",[110,25],"Aesthetics",[112,113],"augmentation","gluteal","2024-08-06",{"date":116,"type":31},"2024-08-09",{"date":118,"type":20},"2025-01",{"date":120,"type":20},"2026-08",{"name":122,"class":38},"MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA"]