[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Orteq Sports Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100654531","long-term-follow-up-of-actifit-meniscal-scaffold-patients-100654531",false,"NCT07800923","Long-term Follow-up of Actifit® Meniscal Scaffold Patients.","Inclusion:\n\nAt time of operation, with respect to the involved knee:\n\n* Patients with irreparable, painful and\u002For dysfunctional meniscal tissue loss having undergone partial meniscectomy.\n* Sufficient rim over the entire circumference of the meniscus to ensure stable fixation.\n* Well aligned knee joint (varus\u002Fvalgus \\\u003C5o) or willing to correct alignment at implant surgery\n* Stable knee joint or ACL deficiencies corrected within 12 weeks after implantation of Actifit.\n* ICRS classification ≤ 3.\n* No more than 3 prior meniscal surgeries on the involved knee.\n\n  * Skeletally mature men or women, aged 16 to 50 years at time of Actifit procedure.\n  * Actifit implantation at a minimum of 4 years ago\n  * Willing to participate in this long-term follow-up study.\n\nExclusion:\n\nAt time of operation:\n\n* PCL insufficiency of the involved knee.\n* Significant uncorrected malformations, axial malalignment in the ipsilateral leg.\n* Documented allergy to any of the product components.\n* Systemic or local infection at the time of the operation.\n* Overweight at the time of operation (defined as BMI greater than 35kg\u002Fm²)\n* Systemic administration of any type of corticosteroid, antineoplastics, immune-stimulating or immunosuppressive agent within 30 days before or after implantation of Actifit.\n* Evidence of osteonecrosis in the involved knee at the time of the operation.\n* Medical history at time of operation that is positive, for, but not restricted to, the following diseases:\n\nRheumatoid arthritis Relapsing polychondritis Severe degenerative osteoarthrosis Inflammatory arthritis","ALL","18 Years","50 Years",{"count":19,"type":20},120,"ESTIMATED","OBSERVATIONAL","This study will collect retrospective patient data of Actifit patients (medial and lateral, isolated cases as well as cases with concomitant procedures), including pre-op and any post-op imaging, for 120 retrospective Actifit patients, to account for drop-outs and patients refusing a follow-up visit\u002Ffollow-up imaging.\n\nEach patient without evidence of previous removal of the scaffold, revision to arthroplasty or joint-modifying surgery at the index knee will be contacted by the site, first by phone, to check whether the Actifit device is still in place or not. If no longer in place, patient's situation will be clearly documented, this will preferentially be done via phone or, if necessary, via a prospective visit. If the Actifit is still in place, a prospective follow-up visit will be organised so that patient's current situation can be documented. The prospective follow-up visit may be via an in-person clinic visit (preferred since the visit, provided the patients agrees, includes imaging), telephone or video conference. Any newly occurring events during this prospective visit will also be documented. Of the 120 retrospective patients, we anticipate a group of about 60-100 study participants with the Actifit still in place and being invited to a prospective follow-up visit.\n\nConsent will be requested to collect specific questionnaires (IKDC, KOOS, VAS-pain and, in case available at baseline, Lysholm) and, in case the study participant also agrees to this, an X-Ray\u002FMRI will be collected, provided any previous imaging is \\> 365 days old.",[24,25],"Meniscus Lesion","Meniscus Tear",[27,28,29,30,31],"Meniscal scaffold for use in the treatment of irrepairable meniscus tears and meniscal tissue loss.","Meniscal scaffold","Meniscal tear","Meniscal lesion","Actifit","NOT_YET_RECRUITING","2026-08-31",{"date":35,"type":36},"2026-09-02","ACTUAL",{"date":38,"type":20},"2026-10",{"date":40,"type":20},"2028-09",{"name":42,"class":43},"Orteq Sports Medicine","INDUSTRY",""]