[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"discopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:discopathy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100442000","post-market-clinical-follow-up-study-with-the-cervical-disc-prothesis-move-c-100442000",false,"NCT05035693","Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C","\"PMCF MOVE®-C\" International, Prospective, Multicentre, Non-randomised Post-market Clinical Follow-up Study Clinical and Radiological Outcome After Mono- and Bisegmental Cervical Intervertebral Disc Prosthetics","PMCF_MOVE®-C","Inclusion Criteria:\n\n1. Diagnosis of discopathy or disc hernia with radiculopathy or stenosis of the foramen and spinal canal,\n2. documented individual history of neck and\u002For upper extremity pain and\u002For functional\u002Fneurological deficit associated with the cervical level to be treated,\n3. no surgical treatment regarding the planned index surgery within the last six weeks prior implantation,\n4. unsuccessful conservative medical care regarding the indication within the last six weeks,\n5. age ≥18 years,\n6. patient must agree to fully participate in the clinical trial and give informed consent in writing,\n7. patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1),\n8. patient information has been provided and all written consents of the patient are available.\n\nExclusion Criteria:\n\n* Known contraindication against the use of cervical intervertebral disc prostheses in accordance with the manufacturer's instructions for use:\n\n  1. Bone mineral density with T-score ≤ -1.5 as determined by spine DXA if male ≥ 60 years of age or female ≥ 50 years of age,\n  2. active systemic infection or infection at the operative site,\n  3. sustained osteoporotic fracture of the spine, hip or wrist,\n  4. spinal metastases,\n  5. known allergy to titanium or polycarbonate-urethane,\n  6. confirmed pregnancy,\n  7. severe cervical myelopathy,\n  8. patients requiring a treatment that destabilises the spine (e.g. posterior element decompression),\n  9. advanced cervical anatomical deformity at the operative site (e.g. ankylosing spondylitis, scoliosis),\n  10. advanced degenerative changes (e.g. spondylosis) at the index vertebral level,\n  11. patient is kept in an institution under judicial or official orders (MPG §20.3).",true,"ALL","18 Years",{"count":21,"type":22},170,"ESTIMATED","INTERVENTIONAL",[25],"NA","Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG.\n\nObjectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.",[28,29,30,31],"Discopathy","Herniated Cervical Disc","Stenoses, Spinal","Radiculopathy",[33,34,28,31],"Herniated Disc","Cervical Spine","RECRUITING","2024-11-13",{"date":38,"type":39},"2024-11-15","ACTUAL",{"date":41,"type":39},"2021-03-11",{"date":43,"type":22},"2027-03-11",{"name":45,"class":46},"NGMedical GmbH","INDUSTRY",7,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100540750","mid--or-high-flex-rods-versus-low-flex-rods-of-spineshape-system-iv-for-treatment-of-degenerative-lumbar-spine-diseases-100540750","NCT06320899","Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases","Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases - a Prospective, Multicenter, Randomized Controlled Non-inferiority Study","Inclusion Criteria:\n\n* degenerative symptoms in 1 to 2 segments in the lumbar spine L1-S1\n* signed informed consent of participant\n* confirmation of the participant that the attendance of follow-up visits are intended\n* Body-Mass-Index \\\u003C 32\n* Pedicle screw axis distance \\\u003C 30mm\n* one or more of the following indications:\n\n  * (dynamic) stenosis in the spinal canal\n  * neuroforaminal stenosis\n  * facet joint syndrome \u002F spondylarthrosis\n  * discopathy (recurrent disc hernia)\n  * degenerative spondylolisthesis (Meyerding \\\u003C1)\n  * instability (hypermobility with antelishtesis, hypomobility with retrolisthesis if decompressed)\n\nExclusion Criteria:\n\n* missing bone structure, e.g. due to congenital anomalies or sever anatomical deformities that make anchoring of the implant impossible\n* damaged structural tissue, e.g. due to a bone fracture\n* application to the thoracic or cervical spine\n* pronounced idiopathic scoliosis\n* spondylolisthesis \\> Meyerding grad 1\n* isthmic spondolylysis\n* bone tumor\n* osteochondrosis modic type I, II or III\n* osteoporosis, which could impair screw anchoring\n* history with third party implants\n* patients with an active local or systemic infection\n* known allergy to titatnium alloys\n* skeleton in growth (epiphyseal joints not closed)\n* severe muscular neuronal or vascular disease\n* immunosuppresive therapy\n* long-term therapy with cortisone\n* heavy smokers (regular consumption of more than six cigarettes per day), drug addicts and alcoholics\n* chronic pain patients\n* incapable of judgment or emergency situation\n* implantation during pregnancy","99 Years",{"count":57,"type":22},126,[25],"The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and safety-related results.\n\nThe primary aim is to compare the reduction in back pain after the treatment with high- or mid-flex rods with that after treatment with low-flex rods. Secondary, the functionality after treatment with high- or mid-flex rods will be compared to that after treatment with low-flex rods.",[61,62,63,28,64,65],"Degenerative Lumbar Spinal Stenosis","Facet Joint Arthrosis","Spondylarthritis","Degenerative Spondylolisthesis","Instability Lumbar Spine","2024-06-21",{"date":68,"type":39},"2024-06-25",{"date":70,"type":39},"2024-06-04",{"date":72,"type":22},"2031-08-31",{"name":74,"class":46},"SpineSave AG"]