[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07348835":3,"trial-entities:NCT07348835":192,"trial-summary:NCT07348835":196},{"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":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":40,"secondary_outcomes":48,"sex":110,"minimum_age":111,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":112,"std_ages":130,"locations":133,"central_contacts":157,"overall_officials":161,"references":162,"see_also_links":188},"NCT07348835","NSH1432","Using a Smart Implantable Device to Compare Early Recovery in Two Different Knee Arthroplasty Approaches","Continuous Monitoring Using a Smart Implantable Device (Persona IQ®) to Compare Medial Parapatellar vs. Subvastus Approaches in Early Post-Operative Total Knee Arthroplasty Recovery","NOT_YET_RECRUITING","2027-01","2026-01","2026-01-16","Total Joint Specialists","NETWORK",false,"This is a single-institution, prospective, randomized study comparing the medial parapatellar and subvastus approaches in primary total knee arthroplasty using continuous, implant-based gait monitoring. Patients receiving a Zimmer Persona IQ smart implant will be followed preoperatively and through the first 30 days post-operatively, with extended follow-up to 6 months. Preoperative activity is captured using iPhone Health step-count data, while post-operative recovery is assessed using continuous tibial implant data, including step count, range of motion, cadence, walking speed, stride length, and distance. These objective metrics are correlated with PROMs. The primary outcome is daily step count. Secondary outcomes include early functional milestones, pain, and patient-reported functional scores. This study is designed to characterize early recovery trajectories and determine whether meaningful differences exist between surgical approaches.",null,[18],"Total Knee Anthroplasty",[20,21,22],"Total Knee Arthroplasty","Medial Parapatellar Approach","Subvastus Approach","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},110,"ESTIMATED",[31,36],{"type":32,"name":33,"description":34,"armGroupLabels":35},"PROCEDURE","Total Knee Arthroplasty Medial Parapatellar Approach","Incision splitting quad",[21],{"type":32,"name":37,"description":38,"armGroupLabels":39},"Total Knee Arthroplasty Subvastus Approach","quad-sparing approach",[22],[41,45],{"measure":42,"description":43,"timeFrame":44},"Step Count (steps\u002Fday)","Continuously recorded from PIQ device after it is implanted during surgery","Through study completion, minimum 6 months",{"measure":42,"description":46,"timeFrame":47},"Recorded from patients iPhone Health App for 2 weeks preoperatively","Baseline",[49,51,53,55,57,59,61,65,69,72,75,78,81,84,87,90,94,98,101,105,108],{"measure":50,"description":43,"timeFrame":44},"Stride Length (m)",{"measure":52,"description":43,"timeFrame":44},"Distance Travelled (km)",{"measure":54,"description":43,"timeFrame":44},"Functional Range of Motion (degrees)",{"measure":56,"description":43,"timeFrame":44},"Tibial Range of Motion (degrees)",{"measure":58,"description":43,"timeFrame":44},"Cadence (steps\u002Fminute)",{"measure":60,"description":43,"timeFrame":44},"Walking Speed (m\u002Fs)",{"measure":62,"description":63,"timeFrame":64},"Goniometric Functional Range of Motion","Measured in degrees using a goniometer","Preoperatively and at 6 weeks",{"measure":66,"description":67,"timeFrame":68},"Surgical Side","Left or Right","Preoperatively",{"measure":70,"description":71,"timeFrame":68},"Age","In years, from EMR",{"measure":73,"description":74,"timeFrame":68},"Sex","Male or Female, from EMR",{"measure":76,"description":77,"timeFrame":68},"Weight","In kg, from EMR",{"measure":79,"description":80,"timeFrame":68},"Height","In cm, from EMR",{"measure":82,"description":83,"timeFrame":68},"Body Mass Index (BMI)","in kg\u002Fm2, from EMR",{"measure":85,"description":86,"timeFrame":68},"Comorbidities","Collected and listed from EMR",{"measure":88,"description":89,"timeFrame":68},"Charlson Comorbidity Index (CCI)","Calculated from formula using comorbidities collected from EMR",{"measure":91,"description":92,"timeFrame":93},"Time to Achieving Key Milestones in Daily Activities","Survey score collected (less time = better), Survey via Force Therapeutics","6 weeks postoperatively",{"measure":95,"description":96,"timeFrame":97},"Veterans Rand 12-Item (VR-12) Health Survey","Mental and Physical component survey scores collected (0-100); Survey via Force Therapeutics","Preoperatively, 6 weeks postoperatively, 6 months postoperatively",{"measure":99,"description":100,"timeFrame":93},"Procedure Satisfaction","Survey score collected (0-5; 5 best), Survey via Force Therapeutics",{"measure":102,"description":103,"timeFrame":104},"Numeric Pain Rating Scale (NPRS)","Survey score collected (0-10; 0 best), Survey via Force Therapeutics","Preoperatively, 6 weeks postoperatively",{"measure":106,"description":107,"timeFrame":97},"Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)","Survey score collected (0-100; 100 best), Survey via Force Therapeutics",{"measure":109,"description":107,"timeFrame":97},"Forgotten Joint Score (FJS)","ALL","18 Years",{"inclusion":113,"exclusion":119,"raw_text":129},[114,115,116,117,118],"All patients older than 18 years of age who plan to undergo medial congruent polyethylene bearing primary TKA with a PIQ","Eligible for both approaches","Have an iPhone and willing to \"wear\" it for two weeks preoperatively to get an estimated average stepcount","Provide informed consent","Willing to complete follow ups",[120,121,122,123,124,125,126,127,128],"Patients with TKA revisions","Patients with insufficient pre-operative range of motion in the operative knee (flexion contracture of \\> 20 degrees or \\\u003C 90° of knee flexion)","Patients with Contralateral TKA within study time frame","Patients with TKA other than medial congruent polyethylene bearing","Patients with bilateral surgery","Patients without a valid and active email address","Patients not willing or able to participate in study and follow-ups","Patients who use assisted devices to ambulate","Rheumatoid arthritis","Inclusion Criteria:\n\n* All patients older than 18 years of age who plan to undergo medial congruent polyethylene bearing primary TKA with a PIQ\n* Eligible for both approaches\n* Have an iPhone and willing to \"wear\" it for two weeks preoperatively to get an estimated average stepcount\n* Provide informed consent\n* Willing to complete follow ups\n\nExclusion Criteria:\n\n* Patients with TKA revisions\n* Patients with insufficient pre-operative range of motion in the operative knee (flexion contracture of \\> 20 degrees or \\\u003C 90° of knee flexion)\n* Patients with Contralateral TKA within study time frame\n* Patients with TKA other than medial congruent polyethylene bearing\n* Patients with bilateral surgery\n* Patients without a valid and active email address\n* Patients not willing or able to participate in study and follow-ups\n* Patients who use assisted devices to ambulate\n* Rheumatoid arthritis",[131,132],"ADULT","OLDER_ADULT",[134],{"facility":135,"city":136,"state":137,"zip":138,"country":139,"contacts":140,"geoPoint":154},"Total Joint Surgery Center Atlanta","Sandy Springs","Georgia","30328","United States",[141,146,147,150,152],{"name":142,"role":143,"phone":144,"email":145},"Zachary M Ricciardelli, B.S.","CONTACT","(615)-957-0334","zach.ricciardelli@gmail.com",{"role":143,"email":145},{"name":148,"role":149},"Thomas L Bradbury, M.D.","PRINCIPAL_INVESTIGATOR",{"name":142,"role":151},"SUB_INVESTIGATOR",{"name":153,"role":151},"Charlotte C Baker, B.S.",{"lat":155,"lon":156},33.92427,-84.37854,[158],{"name":148,"role":143,"phone":159,"email":160},"(404)-759-3912","tombradburymd@gmail.com",[],[163,167,170,173,176,179,182,185],{"pmid":164,"type":165,"citation":166},"10693563","BACKGROUND","Matsueda M, Gustilo RB. Subvastus and medial parapatellar approaches in total knee arthroplasty. Clin Orthop Relat Res. 2000 Feb;(371):161-8. doi: 10.1097\u002F00003086-200002000-00020.",{"pmid":168,"type":165,"citation":169},"28947369","Kazarian GS, Siow MY, Chen AF, Deirmengian CA. Comparison of Quadriceps-Sparing and Medial Parapatellar Approaches in Total Knee Arthroplasty: A Meta-Analysis of Randomized Controlled Trials. J Arthroplasty. 2018 Jan;33(1):277-283. doi: 10.1016\u002Fj.arth.2017.08.025. Epub 2017 Aug 30.",{"pmid":171,"type":165,"citation":172},"11880904","Cila E, Guzel V, Ozalay M, Tan J, Simsek SA, Kanatli U, Ozturk A. Subvastus versus medial parapatellar approach in total knee arthroplasty. Arch Orthop Trauma Surg. 2002 Mar;122(2):65-8. doi: 10.1007\u002Fs004020100319.",{"pmid":174,"type":165,"citation":175},"24897738","Tomek IM, Kantor SR, Cori LA, Scoville JM, Grove MR, Morgan TS, Swarup I, Moschetti WE, Spratt KF. Early Patient Outcomes After Primary Total Knee Arthroplasty with Quadriceps-Sparing Subvastus and Medial Parapatellar Techniques: A Randomized, Double-Blind Clinical Trial. J Bone Joint Surg Am. 2014 Jun 4;96(11):907-915. doi: 10.2106\u002FJBJS.L.01578. Epub 2014 Jun 4.",{"pmid":177,"type":165,"citation":178},"21862334","Alcelik I, Sukeik M, Pollock R, Misra A, Naguib A, Haddad FS. Comparing the mid-vastus and medial parapatellar approaches in total knee arthroplasty: a meta-analysis of short term outcomes. Knee. 2012 Aug;19(4):229-36. doi: 10.1016\u002Fj.knee.2011.07.010. Epub 2011 Aug 20.",{"pmid":180,"type":165,"citation":181},"34408867","Khan MNH, Abbas K, Faraz A, Ilyas MW, Shafique H, Jamshed MH, Hashmi P. Total knee replacement: A comparison of the subvastus and medial parapatellar approaches. Ann Med Surg (Lond). 2021 Aug 8;68:102670. doi: 10.1016\u002Fj.amsu.2021.102670. eCollection 2021 Aug.",{"pmid":183,"type":165,"citation":184},"20953864","van Hemert WL, Senden R, Grimm B, van der Linde MJ, Lataster A, Heyligers IC. Early functional outcome after subvastus or parapatellar approach in knee arthroplasty is comparable. Knee Surg Sports Traumatol Arthrosc. 2011 Jun;19(6):943-51. doi: 10.1007\u002Fs00167-010-1292-0. Epub 2010 Oct 17.",{"pmid":186,"type":165,"citation":187},"29657848","Berstock JR, Murray JR, Whitehouse MR, Blom AW, Beswick AD. Medial subvastus versus the medial parapatellar approach for total knee replacement: A systematic review and meta-analysis of randomized controlled trials. EFORT Open Rev. 2018 Mar 26;3(3):78-84. doi: 10.1302\u002F2058-5241.3.170030. eCollection 2018 Mar.",[189],{"label":190,"url":191},"Persona IQ Device","https:\u002F\u002Fwww.zimmerbiomet.com\u002Fen\u002Fproducts-and-solutions\u002Fspecialties\u002Fknee\u002Fpersona-iq.html",{"nct_id":4,"conditions":193,"biomarkers":195},[194],"Total Knee Replacement",[],{"nct_id":4,"found":197,"summary":198,"prompt_version":208},true,{"design":199,"status":200,"heading":201,"summary":202,"follow_up":203,"word_count":204,"commitments":205,"compensation":206,"drugs_mentioned":207},"This is a randomized study comparing two surgical approaches for total knee replacement, with 110 planned participants. Participants will be randomly assigned to one of the two surgical groups.","completed","Comparing Knee Replacement Approaches with a Smart Implant","This study is comparing two different surgical approaches for total knee replacement (Total Knee Arthroplasty): the Medial Parapatellar Approach and the Subvastus Approach. Both approaches involve surgery to replace your knee joint. Researchers want to see which approach leads to a better and faster recovery. They will use a special smart implant called Zimmer Persona IQ to track your activity, like how many steps you take each day, after surgery. To join, you must be over 18, planning to have a primary total knee replacement, be eligible for both surgical approaches, and have an iPhone you're willing to use for two weeks before surgery to track your steps. The main goal is to see if there's a difference in daily step count between the two groups. The study's current status is unclear.","Participants will be followed through study completion, with a minimum of 6 months of follow-up after surgery.",132,"You would need to use your iPhone to track your steps for two weeks before surgery. After surgery, the smart implant will continuously track your recovery, and you will have follow-up appointments.","Not stated in the trial record.",[],"v2"]