[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Arthrex, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":177},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,53,76,107,130,156],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100417396","evaluate-the-continued-safety-and-performance-of-the-foot-and-ankle-products-100417396",false,"NCT04715139","Evaluate the Continued Safety and Performance of the Foot and Ankle Products","A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products","Inclusion Criteria:\n\n1. Subject requires surgery using Arthrex foot and ankle products included in the registry.\n2. Subject is 18 years of age or over (all products except ProStop®).\n3. Subject age \\>two to 17 years (ProStop® product only).\n4. Capable of completing self-administered questionnaires.\n5. Willing and able to return for all study-related follow-up visits.\n6. Subject or subject's representative signed informed consent and assent, when applicable, and is willing and able to comply with all study requirements.\n\n   (ArthroFLEX® subjects only):\n7. Degenerative or post-traumatic arthritis of the 1st MTP joint with grade 2, 3, or 4.\n8. Subjects who require surgical intervention or are medically indicated for an arthrodesis or arthroplasty of the 1st MTP.\n\n   DualCompression Hindfoot Nail subjects only:\n9. The participant must have instability, arthritis, rigid deformity, or severe foot or ankle deformity necessitating tibiotalocalcaneal arthrodesis, commonly referred to as TTC arthrodesis.\n10. The participant should be undergoing treatment with the Arthrex DualCompression Hindfoot Nail, either as a primary procedure or as a revision surgery, per standard of care\n\nExclusion Criteria:\n\n1. Insufficient quantity or quality of bone.\n2. Blood supply limitations and previous infections, which may retard healing.\n3. Foreign-body sensitivity.\n4. Any active infection or blood supply limitations.\n5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.\n6. Subjects that are skeletally immature (except for ProStop®).\n7. Subject is considered from vulnerable population (i.e., child, prisoner, pregnant).\n8. Subjects who are contraindicated for these devices.\n9. Subject is currently receiving compensation or benefits due to a work-related injury or illness under any applicable occupational injury or disability program.\n10. Subject has a planned or scheduled additional surgery on the affected or contralateral lower extremity within the course of the study.\n\n    (® Nitinol Staple Subjects only):\n11. Subjects who have a comminuted bone surface that would not allow for staple placement as required by the DynaNite® Nitinol Staples directions for use.\n12. Subjects who have pathologic bone conditions such as osteopenia that would impair the ability to securely fix the implant as required by the DynaNite® Nitinol Staples directions for use.\n\n    (ArthroFLEX® subjects only):\n13. Additional ipsilateral lower limb pathology that requires active treatment.\n14. Bilateral degenerative or post-traumatic arthritis of the 1st MTP joints that would require simultaneous treatment of both MTP joints.\n15. Diagnosis of gout.\n16. Any significant bone loss, avascular necrosis, and\u002For large osteochondral cyst (\\>1cm) of the 1st MTP joint.\n17. Lesions greater than 10mm in size.\n18. Hallux varus to any degree, or hallux valgus \\>20 degrees.\n\n    (DualCompression Hindfoot Nail subjects only):\n19. Requiring only a tibiotalar or subtalar arthrodesis\n20. Patient requires bulk allograft or metal spacer implant to fill large bony defect and aid in limb salvage",true,"ALL","2 Years",{"count":20,"type":21},700,"ESTIMATED","24 Months","OBSERVATIONAL","The objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of the foot; TRIM-IT Drill Pin® system and\u002For TRIM-IT Spin Pin™ system for fixation of fractures and fusion (bunionectomy osteotomies) of the foot\u002Fankle; Headless Compression Screws and Compression FT Screws for fixation of small bone fragments of the foot\u002Fankle; DynaNite® nitinol staple for midfoot and hindfoot arthrodeses or osteotomies, first metatarsophalangeal arthrodesis, and mono or bi-cortical osteotomies in the forefoot; BioComposite SutureTak® anchor for medial ankle stabilization; Beveled FT Screws for hallux valgus repair; KreuLock™ screws for ankle fractures; ArthroFLEX® dermal allograft for hallux rigidus arthroplasty; and DualCompression Hindfoot Nail for tibiotalocalcaneal arthrodesis.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Hyperpronated Foot","Reconstruction Surgeries of the Foot","Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot\u002FAnkle","Fixation of Small Bone Fragments of the Foot\u002FAnkle","Lisfranc Arthrodesis","Mono or Bi-cortical Osteotomies in the Forefoot","First Metatarsophalangeal Arthrodesis","Akin Osteotomy","Midfoot and Hindfoot Arthrodeses or Osteotomies","Fixation of Osteotomies for Hallux Valgus Treatment (Scarf and Chevron)","Arthrodesis of the Metatarsocuneiform Joint to Reposition and Stabilize Metatarsus Primus Varus","Osteotomy Fixation of Hallux Valgus Repair (Such as Scarf and Chevron Etc.)","Medial Ankle Stabilization","Tibiotalocalcaneal Arthrodesis","RECRUITING","2026-02-09",{"date":43,"type":44},"2026-02-11","ACTUAL",{"date":46,"type":44},"2020-12-01",{"date":48,"type":21},"2027-12-31",{"name":50,"class":51},"Arthrex, Inc.","INDUSTRY",7,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":63,"studyType":23,"phases":4,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100325021","total-shoulder-arthroplasty-multi-center-registry-100325021","NCT03511586","Total Shoulder Arthroplasty Multi-Center Registry","Inclusion Criteria:\n\n1. Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.\n2. Patient is between the ages of 18 and 100 years.\n3. The patient has a planned primary or revision implantation of an anatomic (hemi-arthroplasty or total arthroplasty) or a reverse shoulder prosthesis system manufactured by Arthrex.\n4. Patient has a standard of care preoperative CT taken within 6 months that has been submitted for Arthrex VIP (Virtual Implant Positioning) planning.\n\nExclusion Criteria\n\n1\\. Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study.","18 Years","100 Years",{"count":62,"type":21},2500,"10 Years","The objective of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.",[66],"Shoulder Arthroplasty","2025-08-06",{"date":69,"type":44},"2025-08-11",{"date":71,"type":44},"2015-07-28",{"date":73,"type":21},"2035-11",{"name":50,"class":51},24,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":16,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":83,"targetDuration":85,"studyType":23,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100442839","registry-of-arthrex-hand-and-wrist-products-100442839","NCT05046600","Registry of Arthrex Hand and Wrist Products","Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products","Inclusion Criteria:\n\n1. Subject requires surgery using Arthrex hand and wrist implants included in the registry.\n2. Subject is 18 years of age or over.\n3. Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).\n4. Subject signed informed consent and is willing and able to comply with all registry requirements\n\nExclusion Criteria:\n\n1. Insufficient quantity or quality of bone.\n2. Blood supply limitations and previous infections, which may retard healing.\n3. Foreign-body sensitivity or foreign-body reactions.\n4. Any active infection or blood supply limitations.\n5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.\n6. Subjects that are skeletally immature -",{"count":84,"type":21},650,"12 Months","A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products",[88,89,90,91,92,93,94,95,96,97],"Ulnar\u002FRadial Collateral Ligament Reconstruction","Ligament Repair or Reconstruction","Small Bone Fragments and Arthrodesis","Scapholunate Ligament Reconstruction","Carpal Fusion (Arthrodesis) of the Hand","Digital Tendon Transfers","Carpometacarpal Joint Arthroplasty","Arthrodesis","Digital Tendon Transfer","Distal Radius Fracture Fixation","2025-06-23",{"date":100,"type":44},"2025-06-26",{"date":102,"type":44},"2021-07-20",{"date":104,"type":21},"2025-12-01",{"name":50,"class":51},5,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100514694","dermal-allograft-augmentation-of-large-and-massive-rotator-cuff-tears-100514694","NCT05981833","Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears","A Randomized, Post-market Study Evaluating Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears","Inclusion Criteria:\n\n* The subject is between the ages of 30 and 75 years.\n* Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)\n* Two complete RCTs or tear size equal to or greater than 3 cm in either the anterior-posterior or medial-lateral dimension\n* Primary rotator cuff repair\n* Stage II fatty infiltration or higher of the supraspinatus or infraspinatus muscle based on preoperative MRI6. Subject has a dual x-ray absorptiometry (DXA) or anterior posterior x-ray view of the target shoulder\n\nExclusion Criteria:\n\n* The Subject is unable or unwilling to sign the patient informed consent, approved by the Institutional Review Board.\n* The subject objects to the use of allograft\n* Stage I or lower fatty infiltration of the supraspinatus AND infraspinatus muscle\n* Complete full-thickness subscapularis tears of greater than the superior one third of the tendon (Lafosse grade 3 and above)\n* Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph\n* Recurrent shoulder instability\n* Corticosteroid injection in the operative shoulder within one month of surgery\n* Revision rotator cuff repair\n* Subject preoperative MRI obtained more than 12 months prior to surgery\n* Pregnant or planning to become pregnant during the study period\n* Workman's compensation case\n* Subject has conditions or circumstances that would interfere with study requirements.\n\nIntraoperative exclusion criteria:\n\nPartial rotator cuff repairs\n\nLafosse grade 3 or higher subscapularis tears","30 Years","75 Years",{"count":117,"type":21},120,"The purpose of this study is to compare postoperative healing of large and massive rotator cuff tears with preoperative MRI confirmed fatty infiltration stage II and higher repaired with or without dermal allograft augmentation (DAA).",[120],"Full-thickness Rotator Cuff Tear","2025-02-21",{"date":123,"type":44},"2025-02-24",{"date":125,"type":44},"2023-09-25",{"date":127,"type":21},"2026-09-15",{"name":50,"class":51},4,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":16,"sex":17,"minAge":59,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},"100562482","nanoscope-cost-analysis-study-100562482","NCT06603740","Nanoscope Cost Analysis Study","Randomized Study Evaluating Cost of Arthrex Nano Arthroscopy Products in Arthroscopic Knee Meniscectomy Versus Conventional Arthroscopy","Inclusion Criteria:\n\n1. Subject requires simple partial posterior or mid-body meniscectomy.\n2. Subject is 18 - 60 years of age.\n3. Subject body mass index (BMI) is 35 or lower (BMI ≤ 35).\n4. Subject signed informed consent and is willing and able to comply with all study requirements and follow-up visits.\n5. Confirmed meniscal injury by physical exam as per standard of care.\n6. Normal mechanical alignment; \\\u003C 5° varus and \\\u003C 7° valgus, of the affected knee by clinical assessment or X-Rays as per standard of care\n\nExclusion Criteria:\n\n1. Subject requires complex repair or anterior meniscectomy.\n2. Subject has a concomitant chondral lesion of the ipsilateral knee in addition to meniscal tear.\n3. Current bilateral knee injury.\n4. Insufficient quantity or quality of bone.\n5. Blood supply limitations and previous infections which may retard healing.\n6. Congenital ligamentous hypermobility defined by Beighton score 4 or 5.\n7. Locked knee or haemarthrosis.\n8. Subjects that are skeletally immature.\n9. Advanced Osteoarthritis; Kellgren Lawrence ≥ 2\n10. Fracture of the lower extremities within 6 months prior to screening.\n11. Previous surgery on the affected knee within 12 months prior to screening.\n12. Sensitivity to silicone, polyester, nylon, FD\\&C Blue No. 2 dye and beeswax.\n13. Other concomitant disease that would interfere with study outcomes.\n14. Subject is included in a vulnerable population (child, prisoner, etc).\n15. Conditions that tend to limit the patient's ability or willingness to restrict activities, follow directions, or perform online subject assessments during the healing period.\n16. Subject is requesting or receiving Worker's compensation related to the knee injury. -","60 Years",{"count":139,"type":21},10,"INTERVENTIONAL",[142],"NA","The study is a pilot study designed to generate preliminary data regarding the cost of partial meniscectomy using NanoScope versus conventional arthroscopy in a traditional operating room (OR) setting",[145],"Meniscal Tear","NOT_YET_RECRUITING","2024-09-17",{"date":149,"type":44},"2024-09-19",{"date":151,"type":21},"2024-11",{"date":153,"type":21},"2025-07",{"name":50,"class":51},1,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":137,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":106},"100463431","knee-related-subchondral-bone-lesions-treated-with-iobp-100463431","NCT05314608","Knee Related Subchondral Bone Lesions Treated With IOBP","Prospective Study of Bone Pathologies Resulting From Acute or Chronic Injury Treated With IntraOsseous BioPlasty® (IOBP®) Surgical Technique","IOBP","Inclusion Criteria:\n\n1. Able to read, understand, sign and complete informed consent\n2. Male or female subject between the ages of 18-60 years\n3. Subject has had pain for greater than three months\n4. Subjects with single SBP in tibia or femur confirmed by minimum 1.5T MRI (including coronal, axial, sagittal, lateral femur, and lateral tibia views) and are candidates for an IOBP® procedure\n5. Subject has stable ligaments\n6. Subject has neutral alignment (max 5° varus or valgus)\n7. Subject has a VAS score greater than or equal to five\n8. Subject is scheduled to undergo surgical intervention using IOBP®\n\nExclusion Criteria:\n\n1. Subject has diabetes Type I, Type II uncontrolled, or Type II insulin dependent\n2. Subject has had lower extremity surgery within six months\n3. Subject has had more than two prior surgical procedures in the operative leg\n4. Subject has a neuromuscular condition\n5. Subject has a current infection\n6. Subject has a BMI \\>35\n7. Subject has subchondral bone collapse or Kellgren Lawrence grade IV osteoarthritis\n8. Subject has joint surface collapse in late stage avascular necrosis\n9. Subject has majority of pain associated with alternate conditions\n10. Subject has had subchondral bone pathology caused by acute trauma\n11. Subject is not neurologically intact.\n12. Subject has history of invasive malignancy (except non-melanoma skin cancer)\n13. Subject that has a planned or scheduled additional surgery within the course of the study (lower extremity)\n14. Subject has an active substance abuse problem\n15. Subject is currently taking narcotic pain medication\n16. Subject is pregnant or planning to become pregnant\n17. Subject is on worker's compensation\n18. Subject has a concomitant procedure not including meniscectomy, synovectomy, chondroplasty, or removal of loose body\n19. Inability to complete study requirements and follow-up visits\n20. Subject that has a bone marrow aspiration that does not meet 60cc",{"count":165,"type":21},100,"The study will be a prospective, multicenter clinical study evaluating clinical and patient reported outcome measures of subjects receiving IOBP® surgical technique using Angel cPRP and BMA processing system to treat subchondral bone pathology (SBP).",[168],"Subchondral Cyst","2022-12-02",{"date":171,"type":44},"2022-12-05",{"date":173,"type":44},"2021-11-17",{"date":175,"type":21},"2027-05-17",{"name":50,"class":51},""]