[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06627673":3,"trial-entities:NCT06627673":158,"trial-summary:NCT06627673":162},{"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":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":91,"locations":94,"central_contacts":116,"overall_officials":125,"references":130,"see_also_links":157},"NCT06627673","PK-00001","MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design","MultiCenter Prospective Parallel Registry Controlled Investigational Device Exemption Clinical Study to Determine Non-Inferiority of the PEEK-OPTIMA™ Femoral Component Versus a CoCr Alloy Femoral Component of Similar Design for TKA","RECRUITING","2029-03-01","2026-06","2026-06-26","2026-01-01","Maxx Orthopedics Inc","INDUSTRY",true,"The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured from polyether-ether-ketone (PEEK).","The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured from polyether-ether-ketone (PEEK).\n\nPEEK is a high-performance, engineering thermoplastic characterized by an unusual combination of properties. These properties range from high temperature performance to mechanical strength and excellent chemical resistance.\n\nThe PEEK-OPTIMA® femoral component, is an investigational device and is the subject of this study approved for IDE by the Federal Food and Drug Administration (FDA).\n\nMaxx Orthopedics, Freedom Total Knee System is used with instrumentation to assist with surgery of the knee. The Maxx Orthopedics, Freedom Total Knee System implants are approved by the FDA for use in the United States and is not investigational.\n\nAll patients will receive the Freedom Total Knee System with the PEEK femoral component. Patient \u002F study participents' records will be reviewed for identification of any and all complications, post-operative care, component safety and efficacy, and if re-operation is needed.",[19],"Knee Osteoarthritis",[21,22,23],"Total Knee Replacement","Total Knee Arthroplasty","Polyether-ether-ketone","INTERVENTIONAL","BASIC_SCIENCE",[27],"NA",{"count":29,"type":30},200,"ESTIMATED",[32],{"type":33,"name":22,"description":34,"armGroupLabels":35,"otherNames":37},"DEVICE","Primary Total Knee Arthroplasty with a PEEK femoral component",[36],"Treatment arm utilizing primary TKA with PEEK femoral component",[21],[39],{"measure":40,"description":41,"timeFrame":42},"Original Knee Society Score","The Knee Society Score rating system was first introduced during the late 1980's and has become the standard clinical evaluation system for reporting results for patients undergoing Total Knee Arthroplasty. Most major journals strongly encourage that total knee manuscripts include Knee Society Score rating scores as part of the result section. The Knee Society Score consists of points given for pain, range of motion, and stability. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices.\n\nThe Knee Society Score is usually reported as the two scores, \"Knee Score\" and \"Function Score,\" rather than a summation score. The KSS score has a maximum of 100 points for each domain (Knee and Function).","24 months post-treatment.",[44,47,49,53,56,59],{"measure":45,"description":41,"timeFrame":46},"Knee Society Score (Knee Scores)","Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment",{"measure":48,"description":41,"timeFrame":46},"Knee Society Score (Function Scores)",{"measure":50,"description":51,"timeFrame":52},"Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)","The KOOS-JR is self-administered and assesses three domains: stiffness (1 question), pain (4 questions), function \u002F daily living (2 questions). The KOOS-JR meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome. Each item (questions) is coded from 0 to 4. The raw responses are summed (0-28) which is then converted to an interval score based on the KOOS-JR conversion table. The score is a percentage score from 0 to 100, 0 representing total knee disability and 100 representing perfect knee health.","• Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment",{"measure":54,"description":55,"timeFrame":52},"The Patient Reported Outcomes Measurement Information System (PROMIS) Global-10","The Patient Reported Outcomes Measurement Information System (PROMIS Global-10) is a valid and reliable patient assessment and consists of ten (10) items that measure physical health, physical functioning, general mental health, emotional distress, satisfaction with social activities and relationships, ability to carry out usual social activities and roles, pain, fatigue and overall quality of life. The response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the \"T-Score\". The average \"T-Score\" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. The PROMIS 10 scores are predictive of healthcare utilization, mortality in general and disease-specific clinical populations.",{"measure":57,"description":58,"timeFrame":46},"Visual-Analog Scale (VAS) score","This scale has been designed to give subjective pain information as to the degree of knee pain you the patient is currently experiencing. VAS scoring is included in the PROMIS GLOBAL-10 assessment and is not necessary to collect a separate assessment. Applying the VAS, the patient will select a number from 1 (no pain) to 10 (maximum pain) that most closely describes their current pain.",{"measure":60,"description":61,"timeFrame":46},"Forgotten Joint Score (FJS-12)","The 12 question Forgotten Joint Score (FJS-12) was introduced with the aim of assessing the patients 'joint awareness'. The authors of the score suggest the \"higher the score\" is more representative of higher-level function after surgery, as to be able to forget about the joint requires the absence of pain and the ability to perform all desired functional tasks without limitation.","ALL","18 Years",null,false,{"inclusion":67,"exclusion":73,"raw_text":90},[68,69,70,71,72],"Male and female subjects 18 years of age or older.","Subjects with a primary diagnosis of end-stage symptomatic unilateral primary knee osteoarthritis.","Subjects with a pre-operative Knee Society Score (KSS) Knee score of \\>25 and \\\u003C75.","Subjects who, in the opinion of the Investigator, can understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.","Subjects who can give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.",[74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89],"Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.","Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.","Subjects who have participated in a clinical study with an investigational product in the last 6 months.","Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e.: muscular dystrophy, polio, neuropathic joints).","Subjects with known osteoporosis and\u002For previous history of fracture related to osteoporosis.","Subjects with a current or active history of malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed, rheumatoid arthritis, sickle cell anemia, and systemic lupus erythematosus.","Subjects defined by the Investigator as American Society of Anesthesiologists (ASA) Grade III or IV.","Subjects who have a neuromuscular or neurosensory deficit.","Female subjects who are pregnant or lactating.","Subjects with an anatomical limb alignment of above 20 degrees varus or valgus.","Subjects with primary or secondary diagnosis of inflammatory or traumatic arthritis.","Subjects with a fixed flexion deformity of over 20 degrees.","Subjects with recurvatum (definition: hyperextension ≥ 5 degrees).","Subjects who have previously undergone surgery on the indicated knee including total knee arthroplasty, patellofemoral arthroplasty, or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, fusion, open reduction and internal fixation.","Subjects that have undergone, or scheduled to undergo, contralateral total knee arthroplasty or unicondylar knee arthroplasty within ±1 year from the study surgical procedure.","Evidence of active or suspected (systemic or local) infection at time of surgery.","Inclusion Criteria:\n\n* Male and female subjects 18 years of age or older.\n* Subjects with a primary diagnosis of end-stage symptomatic unilateral primary knee osteoarthritis.\n* Subjects with a pre-operative Knee Society Score (KSS) Knee score of \\>25 and \\\u003C75.\n* Subjects who, in the opinion of the Investigator, can understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.\n* Subjects who can give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.\n\nExclusion Criteria:\n\n* Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.\n* Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.\n* Subjects who have participated in a clinical study with an investigational product in the last 6 months.\n* Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e.: muscular dystrophy, polio, neuropathic joints).\n* Subjects with known osteoporosis and\u002For previous history of fracture related to osteoporosis.\n* Subjects with a current or active history of malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed, rheumatoid arthritis, sickle cell anemia, and systemic lupus erythematosus.\n* Subjects defined by the Investigator as American Society of Anesthesiologists (ASA) Grade III or IV.\n* Subjects who have a neuromuscular or neurosensory deficit.\n* Female subjects who are pregnant or lactating.\n* Subjects with an anatomical limb alignment of above 20 degrees varus or valgus.\n* Subjects with primary or secondary diagnosis of inflammatory or traumatic arthritis.\n* Subjects with a fixed flexion deformity of over 20 degrees.\n* Subjects with recurvatum (definition: hyperextension ≥ 5 degrees).\n* Subjects who have previously undergone surgery on the indicated knee including total knee arthroplasty, patellofemoral arthroplasty, or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, fusion, open reduction and internal fixation.\n* Subjects that have undergone, or scheduled to undergo, contralateral total knee arthroplasty or unicondylar knee arthroplasty within ±1 year from the study surgical procedure.\n* Evidence of active or suspected (systemic or local) infection at time of surgery.",[92,93],"ADULT","OLDER_ADULT",[95,108],{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":100,"contacts":101,"geoPoint":105},"Ascentis","Leawood","Kansas","66211","United States",[102],{"name":103,"role":104},"Palmisano, MD","CONTACT",{"lat":106,"lon":107},38.96667,-94.6169,{"facility":109,"status":8,"city":110,"state":111,"zip":112,"country":100,"geoPoint":113},"South Texas Bone and Joint","San Antonio","Texas","78249",{"lat":114,"lon":115},29.42412,-98.49363,[117,121],{"name":118,"role":104,"phone":119,"email":120},"Nach Dave, M.S., R.Ph.","732-718-1385","nach.dave@maxxortho.com",{"name":122,"role":104,"phone":123,"email":124},"Corey Perine, BS, MBA","215-432-4323","corey.perine@maxxortho.com",[126],{"name":127,"affiliation":128,"role":129},"Asit Shah, MD, PhD","Chief of Orthopedics - Englewood Hospital","STUDY_CHAIR",[131,135,138,140,142,145,148,151,154],{"pmid":132,"type":133,"citation":134},"15744696","BACKGROUND","Berend KR, Lombardi AV Jr, Mallory TH. Rapid recovery protocol for peri-operative care of total hip and total knee arthroplasty patients. Surg Technol Int. 2004;13:239-47.",{"pmid":136,"type":133,"citation":137},"23244785","Jamsen E, Puolakka T, Eskelinen A, Jantti P, Kalliovalkama J, Nieminen J, Valvanne J. Predictors of mortality following primary hip and knee replacement in the aged. A single-center analysis of 1,998 primary hip and knee replacements for primary osteoarthritis. Acta Orthop. 2013 Feb;84(1):44-53. doi: 10.3109\u002F17453674.2012.752691. Epub 2012 Dec 17.",{"type":133,"citation":139},"Durbhakula SR, L. Restoration of Femoral Condylar Anatomy for Achieving Optimum Functional Expectations: Component Design and Early Results. Recon Review 6(3): 5, 2016",{"type":133,"citation":141},"Durbhakula SD, V.; Durbhakula, N. Restoration of Femoral Condylar Anatomy for Achieving Optimum Functional Expectations: Continuation of an Earlier Study At 5-Year Minimum Follow-Up. Recon Review 9(1): 6, 2019",{"pmid":143,"type":133,"citation":144},"2805470","Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.",{"pmid":146,"type":133,"citation":147},"26926773","Lyman S, Lee YY, Franklin PD, Li W, Cross MB, Padgett DE. Validation of the KOOS, JR: A Short-form Knee Arthroplasty Outcomes Survey. Clin Orthop Relat Res. 2016 Jun;474(6):1461-71. doi: 10.1007\u002Fs11999-016-4719-1. Epub 2016 Feb 29.",{"pmid":149,"type":133,"citation":150},"31256677","Shim J, Hamilton DF. Comparative responsiveness of the PROMIS-10 Global Health and EQ-5D questionnaires in patients undergoing total knee arthroplasty. Bone Joint J. 2019 Jul;101-B(7):832-837. doi: 10.1302\u002F0301-620X.101B7.BJJ-2018-1543.R1.",{"pmid":152,"type":133,"citation":153},"26937689","Thomsen MG, Latifi R, Kallemose T, Barfod KW, Husted H, Troelsen A. Good validity and reliability of the forgotten joint score in evaluating the outcome of total knee arthroplasty. Acta Orthop. 2016 Jun;87(3):280-5. doi: 10.3109\u002F17453674.2016.1156934. Epub 2016 Mar 3.",{"pmid":155,"type":133,"citation":156},"18467932","Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097\u002FMRR.0b013e3282fc0f93.",[],{"nct_id":4,"conditions":159,"biomarkers":161},[160],"Osteoarthritis of knee",[],{"nct_id":4,"found":15,"summary":163,"prompt_version":173},{"design":164,"status":165,"heading":166,"summary":167,"follow_up":168,"word_count":169,"commitments":170,"compensation":171,"drugs_mentioned":172},"This is an interventional study where all participants will receive the Freedom Total Knee System with the PEEK femoral component. It plans to enroll 200 participants.","completed","PEEK-OPTIMA™ Femoral Component for Knee Osteoarthritis","This study is testing a new type of knee implant called the PEEK-OPTIMA™ femoral component, which is part of the Maxx Orthopedics, Freedom Total Knee® System. This component is made from a special plastic called PEEK. Researchers want to see how safe and effective this PEEK component is for people with severe knee osteoarthritis. You might be able to join if you are 18 or older, have painful knee osteoarthritis in one knee, and your Knee Society Score (a measure of knee function) is between 25 and 75. The main goal is to see how your knee function improves after 24 months using the Original Knee Society Score. The study status is currently unclear, and they plan to enroll 200 participants.","Your knee function will be measured at 24 months after your treatment.",121,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]