[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06118892":3,"trial-entities:NCT06118892":125,"trial-summary:NCT06118892":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":40,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":55,"locations":58,"central_contacts":116,"overall_officials":121,"references":123,"see_also_links":124},"NCT06118892","CP0009","MISHA Post-Market Clinical Study","Post-Market Evaluation of the MISHA® Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis","RECRUITING","2030-07-30","2026-07","2026-07-14","2023-11-03","Moximed","INDUSTRY",false,"Prospective evaluation of the safety and effectiveness of the MISHA Knee System.\n\nThe study will collect data on the procedural and long-term adverse events, WOMAC pain and function scores, KSS satisfaction, subsequent surgical interventions, BMI levels, range of motion, UCLA activity level of the subjects, and perform radiographic\u002Fx-ray evaluations at clinical visits through 5 years post-procedure.\n\nThe primary analysis of this study is freedom from device- and procedure-related SSIs at five (5) years post-implantation.\n\nThis study will also assess device performance in subjects with intact and retained devices and subjects with devices removed prior to study termination and freedom from conversion to arthroplasty through 5 years.\n\nStudy subjects will be followed over a five-year post-implant period.",null,[19],"Osteo Arthritis Knee",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},120,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DEVICE","MISHA Knee System","The MISHA Knee System is an extra-capsular knee implant intended to reduce loads on the medial knee. The implant consists of an absorber located between bases fixed with locking screws to the medial cortices of the distal femur and proximal tibia. The implant shares the load with the medial knee joint and articulating ball-and-sockets allow the device to accommodate the natural motions of the knee.",[31],[35],"Implantable Shock Absorber (ISA)",[37],{"measure":38,"timeFrame":39},"Freedom from device- and procedure-related Subsequent Surgical Interventions","5 years post-implantation",[41,45],{"measure":42,"description":43,"timeFrame":44},"WOMAC Pain","Percent of subjects meeting clinically meaningful improvement (defined as ≥ 10-point change from baseline) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used for evaluation of pain. The responses to each question are summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.","5 years",{"measure":46,"description":47,"timeFrame":44},"WOMAC Function","Percent of subjects meeting clinically meaningful improvement (defined as ≥ 10-point change from baseline).\n\nWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used for evaluation of function. The responses to each question are summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.","ALL","25 Years","65 Years",{"inclusion":52,"exclusion":53,"raw_text":54},[],[],"Key Inclusion Criteria:\n\n1. Subjects aged 25 to 65 years at time of index procedure\n2. Body Mass Index (BMI) of \\\u003C 35\n3. Activity exacerbated knee pain isolated to the medial compartment and not global in nature\n4. WOMAC pain ≥ 40\n5. Failed non-operative OA treatment\n\nKey Exclusion Criteria:\n\n1. Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device\n2. Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)\n3. Ligamentous instability\n4. Active or recent knee infection\n5. Inflammatory joint disease, including sequalae of viral infections\n6. Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals\n7. History of keloid, hypertrophic or contracture scaring\n8. Propensity for restrictive scar formation or adhesions with prior procedures",[56,57],"ADULT","OLDER_ADULT",[59,75,87,102],{"facility":60,"status":8,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":72},"Weiss Orthopedics","Sonoma","California","95476","United States",[66,69],{"name":67,"role":68},"Noah Weiss","CONTACT",{"name":70,"role":71},"Noah Weiss, MD","PRINCIPAL_INVESTIGATOR",{"lat":73,"lon":74},38.29186,-122.45804,{"facility":76,"status":8,"city":77,"state":78,"zip":79,"country":64,"contacts":80,"geoPoint":84},"Orthopaedics Specialists of NC","Raleigh","North Carolina","27614",[81,83],{"name":82,"role":68},"Mark Galland, MD",{"name":82,"role":71},{"lat":85,"lon":86},35.7721,-78.63861,{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":64,"contacts":92,"geoPoint":99},"Oregon Health and Science University","Portland","Oregon","97239",[93,95,96],{"name":94,"role":68},"Dennis Crawford, MD",{"name":94,"role":71},{"name":97,"role":98},"Samantha Raphael, PA","SUB_INVESTIGATOR",{"lat":100,"lon":101},45.52345,-122.67621,{"facility":103,"status":8,"city":104,"state":105,"zip":106,"country":64,"contacts":107,"geoPoint":113},"University of Virginia","Charlottesville","Virginia","22903",[108,110,111],{"name":109,"role":68},"David Diduch, MD",{"name":109,"role":71},{"name":112,"role":98},"Frank Gwathmey, MD",{"lat":114,"lon":115},38.02931,-78.47668,[117],{"name":118,"role":68,"phone":119,"email":120},"Rose Weinstein","(510) 887 3375","rsweinstein@moximed.com",[122],{"name":94,"affiliation":88,"role":71},[],[],{"nct_id":4,"conditions":126,"biomarkers":128},[127],"Osteoarthritis",[],{"nct_id":4,"found":130,"summary":131,"prompt_version":141},true,{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This is an interventional study, meaning participants will receive the MISHA Knee System. It plans to enroll 120 participants.","completed","MISHA Post-Market Clinical Study for Knee Osteoarthritis","This study is evaluating the safety and effectiveness of the MISHA Knee System, a device designed to reduce pressure on the inner part of your knee if you have osteoarthritis. The MISHA Knee System is an implant placed between your thigh and shin bones. Researchers want to see how well it works and if it causes any problems over time. You might be able to join if you are between 25 and 65 years old, have a BMI under 35, and experience knee pain mainly on the inner side that hasn't improved with other treatments. The main goal is to see how many people avoid needing additional surgeries related to the device or procedure after 5 years. The current status of this study is unclear, and it plans to enroll 120 participants.","Participants will be followed for 5 years after the device is implanted to assess safety and effectiveness.",132,"Participants will have clinical visits for 5 years after the procedure, which will include evaluations of pain, function, satisfaction, activity levels, and X-rays.","Not stated in the trial record.",[31],"v2"]