[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06975306":3,"trial-entities:NCT06975306":136,"trial-summary:NCT06975306":140},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":54,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":14,"eligibility_criteria":58,"std_ages":71,"locations":73,"central_contacts":104,"overall_officials":109,"references":114,"see_also_links":135},"NCT06975306","STUDY00005122","Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction","RECRUITING","2027-04-30","2026-08","2026-08-14","2025-02-11","University of Arizona","OTHER",false,"All patients will be randomly assigned using a computer randomization algorithm to one of two matched cohort groups. Patients will not be advised which group they belong to until after the completion of the study. One group will be treated with autologous bone graft for bone patellar-tendon bone (BTB) Anterior Cruciate Ligament Reconstruction (ACLR), and the other group will be treated with commercially available DBM (Demineralized bone matrix) putty. Patients will be enrolled from Banner University. Before and after surgery, patient reported outcomes including visual analog pain scale (VAS), Tegner-Lysholm and Cincinnati ACL Test. The principal investigator will evaluate the patients on subjective criteria such as pain and objective criteria including range of motion, arthritic changes seen on radiographs, infection, and ability to kneel.",null,[18,19],"Bone Graft; Complications","ACL Injuries",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},75,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"PROCEDURE","autologous bone grafts","group will be treated with autologous bone graft for BTB ACLR",[34],"autologous bone graft",{"type":13,"name":36,"description":37,"armGroupLabels":38},"Demineralized bone matrix (DBM)","Demineralized bone matrix (DBM) is a biologic allograft product derived from bone tissue that has undergone a process of demineralization to remove inorganic mineral components while retaining the organic matrix, including proteins and growth factors.",[39],"Demineralized bone matrix (DBM) putty",[41,44,46,49,52],{"measure":42,"timeFrame":43},"change in surgical time","Duration of Procedure",{"measure":45,"timeFrame":43},"Change in number of complications from the coring reamer intra-operatively",{"measure":47,"timeFrame":48},"Change in number of complications associated with displacement of the bone graft","1 year post procedure",{"measure":50,"description":51,"timeFrame":48},"Change in outcomes by immediately filling the patellar void following BTB graft harvest","Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Tegner-Lysholm Knee Scoring Scale",{"measure":50,"description":53,"timeFrame":48},"Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Cincinnati Knee Rating System",[],"ALL","18 Years","40 Years",{"inclusion":59,"exclusion":65,"raw_text":70},[60,61,62,63,64],"18-40 years old,","male\u002Ffemale\u002Fgender neutral,","all races not including vulnerable\u002Fspecial consideration populations,","candidate for anterior cruciate ligament reconstruction with bone patellar bone autograft,","compliant post operative course.",[66,67,68,69],"\\\u003C 18, \\>41 years of age,","prior bone patellar bone anterior cruciate ligament reconstruction,","non-compliance post-operatively,","nicotine dependence.","Inclusion Criteria:\n\n* 18-40 years old,\n* male\u002Ffemale\u002Fgender neutral,\n* all races not including vulnerable\u002Fspecial consideration populations,\n* candidate for anterior cruciate ligament reconstruction with bone patellar bone autograft,\n* compliant post operative course.\n\nExclusion Criteria:\n\n* \\\u003C 18, \\>41 years of age,\n* prior bone patellar bone anterior cruciate ligament reconstruction,\n* non-compliance post-operatively,\n* nicotine dependence.",[72],"ADULT",[74,89,95],{"facility":75,"status":7,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":86},"Banner University Medical Center Phoenix","Phoenix","Arizona","85006","United States",[81],{"name":82,"role":83,"phone":84,"email":85},"Marleny Munoz","CONTACT","602-793-9582","marlenymunoz@arizona.edu",{"lat":87,"lon":88},33.44838,-112.07404,{"facility":90,"status":7,"city":76,"state":77,"zip":91,"country":79,"contacts":92,"geoPoint":94},"Banner Health Center Plus - Arcadia","85008",[93],{"name":82,"role":83,"phone":84,"email":85},{"lat":87,"lon":88},{"facility":96,"status":7,"city":97,"state":77,"zip":98,"country":79,"contacts":99,"geoPoint":101},"Banner Sports Medicine Scottsdale","Scottsdale","85256",[100],{"name":82,"role":83,"phone":84,"email":85},{"lat":102,"lon":103},33.50921,-111.89903,[105,106],{"name":82,"role":83,"phone":84,"email":85},{"name":107,"role":83,"email":108},"Phoenix Biomedical Campus Regulatory Team","mlburchfi@arizona.edu",[110],{"name":111,"affiliation":112,"role":113},"Anup Shah, MD","College of Medicine - Phoenix","PRINCIPAL_INVESTIGATOR",[115,119,122,125,128,130,132],{"pmid":116,"type":117,"citation":118},"27357530","BACKGROUND","Schandl K, Horvathy DB, Doros A, Majzik E, Schwarz CM, Csonge L, Abkarovits G, Bucsi L, Lacza Z. Bone-Albumin filling decreases donor site morbidity and enhances bone formation after anterior cruciate ligament reconstruction with bone-patellar tendon-bone autografts. Int Orthop. 2016 Oct;40(10):2097-2104. doi: 10.1007\u002Fs00264-016-3246-8. Epub 2016 Jun 29.",{"pmid":120,"type":117,"citation":121},"31496049","Zhang H, Yang L, Yang XG, Wang F, Feng JT, Hua KC, Li Q, Hu YC. Demineralized Bone Matrix Carriers and their Clinical Applications: An Overview. Orthop Surg. 2019 Oct;11(5):725-737. doi: 10.1111\u002Fos.12509. Epub 2019 Sep 8.",{"pmid":123,"type":117,"citation":124},"35936861","Leafblad ND, Maak TG. Bone Grafting Technique in Revision ACL Reconstruction: Coring Reamer and Dowel Trick. Arthrosc Tech. 2022 Jun 21;11(7):e1367-e1372. doi: 10.1016\u002Fj.eats.2022.03.024. eCollection 2022 Jul.",{"pmid":126,"type":117,"citation":127},"11476385","Tsuda E, Okamura Y, Ishibashi Y, Otsuka H, Toh S. Techniques for reducing anterior knee symptoms after anterior cruciate ligament reconstruction using a bone-patellar tendon-bone autograft. Am J Sports Med. 2001 Jul-Aug;29(4):450-6. doi: 10.1177\u002F03635465010290041201.",{"type":117,"citation":129},"Radiological Society of North America (RSNA) and American College of Radiology (ACR). (2022, November 1). Radiation Dose. Radiologyinfo.org. https:\u002F\u002Fwww.radiologyinfo.org\u002Fen\u002Finfo\u002Fsafety-xrayMedical research",{"type":117,"citation":131},"J. M. Erdal, I. Vik, a. P. Parkar; Bergen\u002FNO & European Society of Radiology. (n.d.). Assessment of effective dose in a series of CT of the knees, time to revise the guidelines? In EPOS. ECR 2016. https:\u002F\u002Fdx.doi.org\u002F10.1594\u002Fecr2016\u002FC-0205",{"pmid":133,"type":117,"citation":134},"30987906","Su AW, Hillen TJ, Eutsler EP, Bedi A, Ross JR, Larson CM, Clohisy JC, Nepple JJ. Low-Dose Computed Tomography Reduces Radiation Exposure by 90% Compared With Traditional Computed Tomography Among Patients Undergoing Hip-Preservation Surgery. Arthroscopy. 2019 May;35(5):1385-1392. doi: 10.1016\u002Fj.arthro.2018.11.013. Epub 2019 Apr 12.",[],{"nct_id":4,"conditions":137,"biomarkers":139},[138],"Injury of anterior cruciate ligament",[],{"nct_id":4,"found":141,"summary":142,"prompt_version":152},true,{"design":143,"status":144,"heading":145,"summary":146,"follow_up":147,"word_count":148,"commitments":149,"compensation":150,"drugs_mentioned":151},"This is an interventional study with 75 participants. You will be randomly assigned to one of two groups, and you won't know which treatment you received until the study ends.","completed","ACL Reconstruction with Bone Grafting Study","This study is looking at two different ways to repair the patellar (kneecap) defect during anterior cruciate ligament (ACL) reconstruction surgery. One group will receive an autologous bone graft, which uses your own bone. The other group will receive Demineralized bone matrix (DBM), a product made from donor bone that helps new bone grow. Researchers want to see if one method leads to fewer complications during surgery and up to one year later. You may be able to join if you are 18-40 years old, need ACL reconstruction with a specific type of bone graft, and can follow post-surgery instructions. The study is currently unclear on its recruitment status.","Your progress will be followed for up to one year after the procedure to check for complications.",109,"You will undergo ACL reconstruction surgery. Before and after surgery, you will complete patient-reported outcome questionnaires, including pain scales and tests related to your knee function.","Not stated in the trial record.",[36],"v2"]