[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"postoperative-edema\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:postoperative-edema":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100647244","effect-of-tergase-injection-on-reducing-edema-after-bilateral-total-knee-arthroplasty-100647244",false,"NCT07705165","Effect of Tergase Injection on Reducing Edema After Bilateral Total Knee Arthroplasty","A Randomized, Split Body, Evaluator-blinded, Trial on the Effect of Tergase Injection (Berahyaluronidase Alfa) on Reducing Edema After Both Total Knee Arthroplasty","ALT-TKA","Inclusion Criteria:\n\n1. Adult males and females aged 60 years or older and 85 years or younger.\n2. Patients scheduled for bilateral total knee arthroplasty due to degenerative knee osteoarthritis with a Kellgren-Lawrence grade of III or IV confirmed by imaging within the last 4 weeks.\n3. Patients experiencing knee joint pain of 5 or higher on a 10-point Visual Analogue Scale (VAS) during daily activities, such as walking on flat ground.\n4. Patients with the willingness and ability to follow the physician's instructions, including joint exercises.\n5. Patients classified as American Society of Anesthesiologists (ASA) Physical Status Class I or II.\n6. Patients who have received a full explanation of the clinical trial and have voluntarily provided written informed consent to participate.\n\nExclusion Criteria:\n\n1. Participants or their family members with ongoing or a history of autoimmune diseases.\n2. Patients with secondary osteoarthritis of the knee.\n3. Patients with inflammatory arthritis (such as rheumatoid arthritis, lupus arthropathy, psoriatic arthritis) or crystal-induced arthropathy.\n4. Patients with a serum protein level of 5.5 g\u002FdL or less.\n5. Patients with clinical laboratory results that are contraindications for total knee arthroplasty:\n\n   1. WBC \\\u003C3,000\u002FμL or \\>12,000\u002FμL\n   2. CRP \\>10 mg\u002FL\n   3. Hb \\\u003C10 g\u002FdL\n   4. Platelet count \\\u003C100,000\u002FμL\n   5. INR \\>1.5\n   6. eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²\n   7. AST or ALT \\>3 times the upper limit of normal\n   8. Fasting blood glucose \\>200 mg\u002FdL\n6. Patients with a history of drug abuse or dependence.\n7. Presence of local infection or sepsis in the affected lower limb, or a history of neurological abnormalities within the past 6 months.\n8. History of major joint surgery within 90 days.\n9. Patients who received systemic steroid treatment within 3 months prior to surgery.\n10. Patients who sustained a serious injury or received an injection in the target knee that may interfere with evaluation within 3 months prior to the screening visit.\n11. Patients with infections requiring hospitalization and administration of antibiotics or antimicrobics.\n12. Patients with any clinically significant medical condition that may interfere with study completion or outcome assessment, including but not limited to:\n\n    1. Congenital heart disease, clinically significant cardiovascular disease, renal dysfunction, or uncontrolled diabetes.\n    2. Neuromuscular disorders affecting the lower limbs.\n    3. Severe bleeding or coagulation disorders.\n    4. Severe knee instability that cannot be corrected with cruciate-retaining total knee arthroplasty.\n    5. Severe knee deformity, defined as flexion contracture ≥30 degrees or varus\u002Fvalgus deformity ≥30 degrees.\n    6. Opioid dependence, defined as consumption of ≥100 mg morphine-equivalent opioids per week for more than 3 months before surgery.\n    7. Inability to assess pain using the Visual Analogue Scale, including cognitive or language impairment.\n    8. Venous congestion of the lower extremity.\n    9. Morbid obesity, defined as body mass index \\>40 kg\u002Fm².\n13. History of shock or hypersensitivity to Tergase inj. or its components.\n14. Patients deemed unsuitable for this study by the investigator, such as those with psychiatric disorders.\n15. Patients currently participating in another clinical trial.","ALL","60 Years","85 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","This clinical trial is conducted to compare and evaluate the efficacy and safety of Tergase injection (4,500 IU) in reducing postoperative edema between treated and untreated knees in patients undergoing bilateral total knee arthroplasty (TKA).\n\nPrior to participation, all subjects receive a full explanation of the study and provide voluntary written informed consent. Only subjects who meet the inclusion and exclusion criteria through screening procedures are enrolled. Enrolled subjects are randomly assigned to the experimental and control groups in a 1:1 ratio per knee, utilizing a split-body clinical trial design that compares both knees of the same subject.\n\nThe analysis target is 60 knees obtained from a total of 30 subjects. According to the randomization results, the knee assigned to the experimental group receives a subcutaneous injection of 3 vials (4,500 IU) of Tergase, while the contralateral knee serves as the untreated control group.\n\nBy including both the experimental and control groups within the same subject, inter-individual variation is minimized. While the investigator performing the injection is aware of the assignment, the subject remains blinded.\n\nTo overcome the physical impossibility of blinding the injector due to the route of administration and drug characteristics, an 'Evaluator-Blinded' design is adopted to maintain objectivity equivalent to a double-blind study. To achieve this, the unblinded injector and the blinded evaluator who measures efficacy outcomes are strictly separated, and operational blinding is maintained by blocking information exchange between the two groups.\n\nSubjects are evaluated for efficacy and safety during hospitalization or outpatient visits at Day 1, 2, 3, 5, Week 2, Week 6, and Month 3 after bilateral TKA. Participation ends upon completion of the planned visits.",[28,29,30],"Osteoarthritis, Knee","Postoperative Edema","Bilateral Total Knee Arthroplasty",[32,33,34,35,29,36],"Tergase","Berahyaluronidase alfa","Recombinant human hyaluronidase","Total Knee Arthroplasty","Split-body trial","NOT_YET_RECRUITING","2026-07-12",{"date":40,"type":41},"2026-07-15","ACTUAL",{"date":43,"type":22},"2026-08-01",{"date":45,"type":22},"2028-03-31",{"name":47,"class":48},"Man Soo Kim","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100646635","circulatory-exercise-after-total-knee-replacement-100646635","NCT07688642","Circulatory Exercise After Total Knee Replacement","Boosting Venous Return After Knee Replacement: Effects of a Novel Circulatory Exercise on Early Postoperative Inflammation - A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults ≥ 18 years undergoing elective unilateral primary TKR for osteoarthritis.\n* Able to provide informed consent.\n* Able to perform the exercise (cognitively and physically) prior to discharge.\n\nExclusion Criteria:\n\n* Preexisting peripheral vascular disease with severe ischemia or venous insufficiency that limits exercise.\n* Contraindication to early active movement per surgeon (e.g., complex surgical fixation limiting motion if present).\n* Severe neurological or cognitive impairment preventing instruction adherence.\n* Inability to comply with follow-up.","18 Years",{"count":58,"type":22},68,[25],"Total knee replacement is commonly associated with early postoperative inflammation, edema, pain, and reduced mobility. This randomized controlled trial will evaluate whether adding a simple circulatory exercise program to standard postoperative rehabilitation reduces early limb edema and inflammatory response after unilateral primary total knee replacement. Participants will be randomized to standard rehabilitation alone or standard rehabilitation plus seated and supine knee-extension exercises with alternating ankle dorsiflexion. The primary endpoint is change in limb edema measured by standardized limb circumference at postoperative day 14.",[62,63,29,64],"Total Knee Replacement","Knee Osteoarthritis","Postoperative Inflammation",[66,67,68,69,70,71,72,73],"Total knee arthroplasty","Total knee replacement","Circulatory exercise","Venous return","Ankle pump exercise","Postoperative edema","Postoperative inflammation","Rehabilitation","2026-07-03",{"date":76,"type":41},"2026-07-07",{"date":78,"type":22},"2026-06-16",{"date":80,"type":22},"2027-05-16",{"name":82,"class":48},"Assiut University",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100593451","hilotherapy-vs-kinesio-taping-in-orthognathic-surgery-recovery-100593451","NCT07006610","Hilotherapy vs. Kinesio Taping in Orthognathic Surgery Recovery","Comparison of the Effects of Hilotherapy and Kinesio Taping on Edema, Pain, and Trismus After Orthognathic Surgery","Inclusion Criteria:\n\n* Patients scheduled to undergo bimaxillary orthognathic surgery (Le Fort I + BSSRO)\n* Age between 18 and 50 years\n* No systemic disease\n* Voluntary participation with signed informed consent\n\nExclusion Criteria:\n\n* Presence of systemic disease or immunosuppressive medication\n* Known allergy to kinesio tape\n* Inability to attend follow-up appointments\n* Facial anatomical deformities preventing measurement","50 Years",{"count":92,"type":22},36,[25],"This prospective randomized controlled trial aims to compare the effects of kinesio taping and hilotherapy on postoperative edema, pain, and trismus in patients undergoing bimaxillary orthognathic surgery.",[29,96,97,98],"Postoperative Pain","Trismus","Orthognathic Surgery",[100,101,98,102,103],"Hilotherapy","Kinesio Taping","Postoperative Complications","Postoperative Recovery","RECRUITING","2025-05-27",{"date":107,"type":41},"2025-06-05",{"date":109,"type":41},"2024-09-15",{"date":111,"type":22},"2025-07-15",{"name":113,"class":48},"Medipol University",1]