[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"degenerative-disc-disease-in-cervical-spine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:degenerative-disc-disease-in-cervical-spine":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":25,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100657059","pmcf-study-fortilink-sc-100657059",false,"NCT07834749","PMCF Study Fortilink-SC","Post-market Clinical Study of the Fortilink-SC Ti","Inclusion Criteria:\n\n1. Willing and able to five voluntary informed consent\n2. Skeletally mature patient\n3. At least 6 weeks of nonoperative treatment\n4. Degenerative disc disease (DDD) of the cervical spine at one or two contiguous levels between C2 and T1, with DDD being defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies\n5. Spinal stenosis\n\nExclusion Criteria:\n\n1. Active systematic infection or an active infection at the operative site\n2. A demonstrated allergy or sensitivity to any of the implanted materials\n3. Severe osteoporosis (confirmed by imaging in the patient's medical history or during screening)\n4. Primary or metastatic tumours affecting the spine (confirmed by imaging in the patient's medical history or during screening)\n5. Conditions that may place excessive stresses on the bones and the implants, including but not limited to morbid obesity or other degenerative diseases, , at the discretion of the investigator\n6. Patients whose ability to follow postoperative restrictions, precautions and rehabilitation programs is limited\n7. Fractures, severe deformities or a severe instability in the area of surgery (confirmed by imaging in the patient's medical history or during screening)\n8. A medical or surgical situation that would preclude the benefit of surgery\n9. Pregnancy\n10. Patient's denial for operative treatment, post-operative rehabilitation program, follow up appointments and\u002For participation in the trial\n11. Protocol specified surgical technique cannot be followed for the subject\n12. Any other reason (in the judgment of the investigator).","ALL",{"count":18,"type":19},50,"ESTIMATED","OBSERVATIONAL","This study is setup to be able to gather information on the safety and performance of the Fortilink-SC Ti cage of Paradigm Spine GmbH, up to one year after the surgery. The device is intended to be used in intervertebral fusion surgery. Around 50 participants will participate in this study in 2 hospitals. The Fortilink-SC Ti cage is meant to be placed in the neck, to treat degenerative disc disease and\u002For stenosis. The study will involve data gathering based on routine care. The study will only entail collection of data (medical history prior to the surgery, data from the surgery and data in the follow up after one year). Fortilink-SC Ti cages are not new, but have been on the market since 2020. The clinical study is performed to actively gather data on the use of this product in the intended group of patients, to monitor its safety and performance. The treatment and follow-up provided in this study does not differ from the standard of care; meaning that participants in the study will receive the same treatment and follow the same follow-up visits and assessments as patients undergoing the same procedure outside of the study.",[23,24],"Degenerative Disc Disease in Cervical Spine","Stenosis Cervical Spine",[26,27,28,29,30,31],"Anterior cervical interbody fusion","ACIF","standalone ACIF","degenerative disc disease","cervical stenosis","PMCF","RECRUITING","2026-09-16",{"date":35,"type":36},"2026-09-22","ACTUAL",{"date":38,"type":36},"2026-01-01",{"date":40,"type":19},"2027-12-31",{"name":42,"class":43},"BAAT Medical Products B.V.","INDUSTRY",2]