[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07709819":3,"trial-entities:NCT07709819":137,"trial-summary:NCT07709819":142},{"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":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":44,"secondary_outcomes":49,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":70,"locations":73,"central_contacts":99,"overall_officials":105,"references":107,"see_also_links":136},"NCT07709819","IIRR-02382","A Nanoscopic Second Look Into the Knee Joint","A Nanoscopic Second Look Into the Knee Joint, What Have We Learned?","RECRUITING","2029-05-20","2026-07","2026-07-17","2026-05-20","Angelina Vera MD","OTHER",false,"The goal of this clinical trial is to look at how well different surgeries heal over time in patients that have previously undergone arthroscopic knee interventions. These procedures may include cartilage repair or grafting, meniscus repair or trimming, ligament reconstruction, cartilage smoothing, and treatments such as amniotic tissue or platelet rich plasma (PRP).\n\nUsing a very small camera called a nanoarthroscope, doctors will take a \"second look\" inside the knee after surgery to see how it has healed. These findings will be compared to patient-reported outcomes, such as pain and function scores, as well as images taken during the original surgery.\n\nThe goal is to determine whether this second look provides useful information that can help guide recovery and future care.","The purpose of this study is to examine the healing potential and mid to long term outcomes of various orthopaedic surgical interventions within the knee joint through a novel modality, bedside nanoarthroscopy. These interventions include but are not limited to: autocartilage grafting, biocartilage grafting, meniscus repair, partial meniscectomy, ligament reconstruction, chondroplasty, as well as amnion placement and platelet rich plasma injection. The \"second look\" nanoscopic outcomes will be compared to the gold standard patient reported outcome measures as well as time of surgery arthroscopic images.\n\nThe individuals recruited for the study will participate in one single clinic visit which will entail a nanoscopic evaluation of their knee. Patients will be asked to fill out a standardized battery of validated patient reported outcome measure surveys and will be consented to undergo a \"nanoscopic second look\" into their knee joint using a nanoscope in the clinic setting. This procedure involves inserting a nanoscopic camera into the knee joint for diagnostic purposes. The nanoscope is no larger than an 18-gauge needle which is routinely used in clinic and hospital settings to deliver injections and perform arthrocentesis.\n\nFor the patients who agree to participate, the following information will be collected from them and from chart review. Injury, procedure performed, date of procedure, and time since procedure. Key images from preoperative MRI will also be accessed along with arthroscopic images from the time of surgery. Nanoscopic images and patient reported outcome measures as described above will also be collected and secured.\n\nUsing a comparison of key slices of preoperative MRI, time of surgery arthroscopic images, and nanoscopic second look images, a percentage of healing will be estimated and recorded. This number will then be compared against scores on the patient reported outcome surveys. This will be repeated for all patients enrolled in the study and statistical analysis will be performed to determine if there is a correlation between patient reported outcome scores and percentage of healing at nanoscopic second look.\n\nSecondary outcomes will also be analyzed including success\u002Ffailure of any biologic augmentation type procedures such as cartilage allograft or autograft and\u002For amniotic membrane use by comparing time of surgery images to nanoscopic second look images\n\nIt will take approximately 2 years to enroll all study subjects and approximately 3 years to complete this study.",[19],"Meniscal Tears",[21,22,23,24,25,26,27,28,29],"Cartilage Repair","Cartilage Grafting","Meniscus Repair","Meniscus Trimming","Ligament Reconstruction","Cartilage Smoothing","Nanoscope","Nanoscopic Diagnostic Arthroscopy","Knee Joint","INTERVENTIONAL","DIAGNOSTIC",[33],"NA",{"count":35,"type":36},15,"ESTIMATED",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42},"PROCEDURE","Nanoscopic Arthroscopy of the Knee","Participants who agree to participate will undergo a postoperative in-clinic nanoscopic arthroscopy of the knee at a routine follow-up visit. A small nanoscope will be inserted into the knee joint in a clinic setting to obtain images that will be used for comparison to the arthroscopic images taken from their surgery and preoperative MRI images. The estimated healing will then be recorded and compared with patient reported outcome survey scores.",[43],"Postoperative Nanoscopic Knee Evaluation",[45],{"measure":46,"description":47,"timeFrame":48},"Correlation between Estimated Percentage Meniscal Healing at Second Look Nanoscopic Arthroscopy and PROMIS Score.","The primary outcome measure is the correlation between estimated meniscal repair healing and change from baseline in PROMIS Physical Function T-Score. Meniscal healing will be assessed using postoperative second-look nanoscopic arthroscopy images obtained 3 to 24 months after the index procedure. The Principal Investigator or delegated trained investigator will visually estimate healing of the original repair site from 0% to 100%, where 0% indicates no observable healing and 100% indicates complete healing with continuous, stable tissue bridging. PROMIS Physical Function will be assessed using the PROMIS Bank v2.0 Physical Function CAT at baseline and at the postoperative nanoscopic visit. The relationship between estimated healing percentage and PROMIS Physical Function T-Score change will be assessed using Spearman's rank correlation coefficient.","From baseline (preoperative assessment) to the postoperative second-look nanoscopic arthroscopy visit (3 to 24 months after the index meniscal repair procedure).",[50],{"measure":51,"description":52,"timeFrame":53},"Estimated Percentage Healing Based on Comparison of Preoperative MRI Intraoperative Arthroscopic Images and Postoperative Nanoscopic Images.","The secondary outcome measure is the estimated percentage of meniscal repair healing based on side-by-side review of intraoperative arthroscopic images and postoperative second-look nanoscopic arthroscopy images. Images will be reviewed by the Principal Investigator or delegated trained investigator using protocol-defined healing criteria. Healing will be visually estimated as the proportion of the original meniscal repair site demonstrating healing and recorded as a percentage from 0% to 100%, where 0% indicates no observable healing and 100% indicates complete healing. Healing percentage will be calculated at the postoperative second-look nanoscopic arthroscopy visit, occurring 3 to 24 months after the index procedure.","From the index procedure to postoperative second-look nanoscopic arthroscopy visit (3 to 24 months after the index procedure).","ALL","18 Years",null,{"inclusion":58,"exclusion":63,"raw_text":69},[59,60,61,62],"Adults aged 18 years and older who have undergone or are scheduled to undergo arthroscopic knee intervention.","Eligible procedures include meniscus repair, biocartilage procedures, and other arthroscopic biologic interventions of the knee","Ability to understand and provide informed consent","Agreement to undergo postoperative in-clinic second-look nanoscopic arthroscopy of the knee.",[64,65,66,67,68],"Refusal to undergo postoperative in-clinic second-look nanoscopic arthroscopy of the knee.","Inability to provide informed consent.","Individuals who are not yet adults (infants, children, teenagers).","Pregnant women","Prisoners","Inclusion Criteria:\n\n* Adults aged 18 years and older who have undergone or are scheduled to undergo arthroscopic knee intervention.\n* Eligible procedures include meniscus repair, biocartilage procedures, and other arthroscopic biologic interventions of the knee\n* Ability to understand and provide informed consent\n* Agreement to undergo postoperative in-clinic second-look nanoscopic arthroscopy of the knee.\n\nExclusion Criteria:\n\n* Refusal to undergo postoperative in-clinic second-look nanoscopic arthroscopy of the knee.\n* Inability to provide informed consent.\n* Individuals who are not yet adults (infants, children, teenagers).\n* Pregnant women\n* Prisoners",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":96},"University Medical Center of Southern Nevada","Las Vegas","Nevada","89102","United States",[81,86,90,93],{"name":82,"role":83,"phone":84,"email":85},"Robert Panganiban","CONTACT","702-383-7336","robert.panganiban@umcsn.com",{"name":87,"role":83,"phone":88,"email":89},"Robert Bimbi, PhD","702-383-7302","robert.bimbi@umcsn.com",{"name":91,"role":92},"Angelina Vera, MD, FAAOS, FAANA","PRINCIPAL_INVESTIGATOR",{"name":94,"role":95},"Christopher J Yergensen, MD","SUB_INVESTIGATOR",{"lat":97,"lon":98},36.17497,-115.13722,[100,103],{"name":101,"role":83,"phone":102,"email":85},"Robert J Panganiban","(702) 383-7336",{"name":87,"role":83,"phone":104,"email":89},"(702) 383-7302",[106],{"name":91,"affiliation":75,"role":92},[108,112,115,118,121,124,127,130,133],{"pmid":109,"type":110,"citation":111},"31533151","BACKGROUND","Farr J, Gomoll AH, Yanke AB, Strauss EJ, Mowry KC; ASA Study Group. A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms. J Knee Surg. 2019 Nov;32(11):1143-1154. doi: 10.1055\u002Fs-0039-1696672. Epub 2019 Sep 18.",{"pmid":113,"type":110,"citation":114},"32076938","Huddleston HP, Cohn MR, Haunschild ED, Wong SE, Farr J, Yanke AB. Amniotic Product Treatments: Clinical and Basic Science Evidence. Curr Rev Musculoskelet Med. 2020 Apr;13(2):148-154. doi: 10.1007\u002Fs12178-020-09614-2.",{"pmid":116,"type":110,"citation":117},"39694969","Utrilla GS, Degano IR, D'Ambrosi R. Efficacy of platelet-rich plasma in meniscal repair surgery: a systematic review of randomized controlled trials. J Orthop Traumatol. 2024 Dec 18;25(1):63. doi: 10.1186\u002Fs10195-024-00799-7.",{"pmid":119,"type":110,"citation":120},"29713647","Kaminski R, Kulinski K, Kozar-Kaminska K, Wielgus M, Langner M, Wasko MK, Kowalczewski J, Pomianowski S. A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Meniscal Healing, Clinical Outcomes, and Safety in Patients Undergoing Meniscal Repair of Unstable, Complete Vertical Meniscal Tears (Bucket Handle) Augmented with Platelet-Rich Plasma. Biomed Res Int. 2018 Mar 11;2018:9315815. doi: 10.1155\u002F2018\u002F9315815. eCollection 2018.",{"pmid":122,"type":110,"citation":123},"23948982","Pujol N, Tardy N, Boisrenoult P, Beaufils P. Magnetic resonance imaging is not suitable for interpretation of meniscal status ten years after arthroscopic repair. Int Orthop. 2013 Dec;37(12):2371-6. doi: 10.1007\u002Fs00264-013-2039-6. Epub 2013 Aug 15.",{"pmid":125,"type":110,"citation":126},"21220542","Miao Y, Yu JK, Ao YF, Zheng ZZ, Gong X, Leung KK. Diagnostic values of 3 methods for evaluating meniscal healing status after meniscal repair: comparison among second-look arthroscopy, clinical assessment, and magnetic resonance imaging. Am J Sports Med. 2011 Apr;39(4):735-42. doi: 10.1177\u002F0363546510388930. Epub 2011 Jan 10.",{"pmid":128,"type":110,"citation":129},"34708138","Dai W, Leng X, Wang J, Hu X, Ao Y. Second-Look Arthroscopic Evaluation of Healing Rates After Arthroscopic Repair of Meniscal Tears: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2021 Oct 22;9(10):23259671211038289. doi: 10.1177\u002F23259671211038289. eCollection 2021 Oct.",{"pmid":131,"type":110,"citation":132},"29804955","Gill TJ, Safran M, Mandelbaum B, Huber B, Gambardella R, Xerogeanes J. A Prospective, Blinded, Multicenter Clinical Trial to Compare the Efficacy, Accuracy, and Safety of In-Office Diagnostic Arthroscopy With Magnetic Resonance Imaging and Surgical Diagnostic Arthroscopy. Arthroscopy. 2018 Aug;34(8):2429-2435. doi: 10.1016\u002Fj.arthro.2018.03.010. Epub 2018 May 24.",{"pmid":134,"type":110,"citation":135},"37105012","Burt J, Smith V, Gee CW, Clarke JV, Hall AJ. The role of outpatient needle arthroscopy in the diagnosis and management of musculoskeletal complaints: A systematic review of the Arthrex NanoScope. Knee. 2023 Jun;42:246-257. doi: 10.1016\u002Fj.knee.2023.04.003. Epub 2023 Apr 25.",[],{"nct_id":4,"conditions":138,"biomarkers":141},[139,140,19],"Cartilage Damage","Ligament Injury",[],{"nct_id":4,"found":143,"summary":144,"prompt_version":153},true,{"design":145,"status":146,"heading":6,"summary":147,"follow_up":148,"word_count":149,"commitments":150,"compensation":151,"drugs_mentioned":152},"This is an interventional study with a planned enrollment of 15 participants. It involves a single-arm design where all participants will undergo the nanoscopic arthroscopy procedure.","completed","This study is looking at how well different knee surgeries heal over time. If you've had or are planning to have knee surgery like meniscus repair or cartilage procedures, you might be able to join. Doctors will use a very small camera, called a nanoscope, to look inside your knee after surgery to see how it has healed. This \"second look\" will be compared to your pain and function scores, and images from your original surgery. The goal is to see if this nanoscopic view provides helpful information for your recovery and future care. The study is currently recruiting about 15 participants.","Your healing will be assessed from your preoperative assessment up to 3 to 24 months after your initial knee surgery.",102,"If you participate, you will have one clinic visit where a nanoscope will be inserted into your knee. You will also fill out surveys about your knee's function and pain.","Not stated in the trial record.",[],"v2"]