|- candidate number||27783|
|- NTR Number||NTR6664|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-aug-2017|
|- Secondary IDs||NL62466.018.17 ABR: 62466|
|- Public Title||AS: Ankle Spacer|
|- Scientific Title||A prospective trial on the clinical efficacy of the Ankle Spacer for the surgical treatment of large, multiple, cystic and secondary or tertiary osteochondral defects of the talus|
|- hypothesis||Despite the fact that no clinical trials have been published on this specific implant, it is hypothesized that the 5-year postoperative clinical outcomes concerning pain and prosthesis survival will be considered good.|
|- Healt Condition(s) or Problem(s) studied||Osteochondral defect, Talus|
|- Inclusion criteria||-age ranging from 18 to 80 years |
-talar osteochondral defect (multiple degenerative talar cysts present, and/or prior failed surgical treatment and/or multiple defects and/or large (>15mm))
-willing to receive surgical implantation of the Ankle Spacer
-has been informed of the nature of the study and provided written consent
-The subject and treating physician agree that the subject will return for all required post-procedure follow-up visits
-failed previous conservative treatment
-complaints for at least 6 months
|- Exclusion criteria||-severe ankle malalignement.(> 5° varus/valgus). |
-fracture < 6 months - tendinitis - diabetes mellitus / reumathoid arthritis
-grade two or higher (Kellgren-Lawrence-Score) ankle joint degeneration on the tibia side.
-any ankle deformation that does not allow proper rasping of the cartilage and/or proper seating of the desired sized implant, as described in the surgical technique.
-blood supply limitations and previous infections, which may retard healing.
-foreign-body sensitivity. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
-active infection or blood supply limitations.
-conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period, including severe neuro-arthropathy.
-pathological conditions, such as insufficient quantity or quality of bone (e.g., cystic changes or severe osteopenia), which may compromise implant fixation.
-currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
-Inability to be brought back to the surgery site for long term follow-up evaluations or the subject is unwilling to fill out the appropriate evaluation forms
-adiposity grade I (BMI > 30 kg/m2)
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-sep-2017|
|- planned closingdate||1-sep-2024|
|- Target number of participants||20|
|- Interventions||All included patients will be treated by means of surgical implantation of the Ankle Spacer prosthesis in an open manner replacing the talar side of the tibiotalar joint.|
|- Primary outcome||The primary study parameter is the measurement of the NRS pain during walking/normal weight-bearing.|
|- Secondary outcome||Other outcome measures will include pain evaluation using the NRS pain at rest and during stair climbing, the AOFAS, FAOS, and SF-36 physical and mental component scale. Range of Motion (ROM) will also be registered in degrees of dorsi- and plantarflexion and will be measured using a goniometer Other study parameters that will be recorded are demographic data (sex, age, etc.) and also radiographic evaluations to evaluate loosening and subsidence (radiographs). Complications, implant survivorship (revision rate), operation time, adverse events, and length of hospital stay will also be recorded.
1 day postoperatively
2 weeks posoperatively
6 weeks postoperatively
3 months postoperatively
6 months postoperatively
1 year postoperatively
3 years postoperatively
4 years postoperatively
5 years postoperatively
|- Trial web site||N.A.|
|- CONTACT FOR PUBLIC QUERIES|| Jari Dahmen|
|- CONTACT for SCIENTIFIC QUERIES|| Jari Dahmen|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Publications||Up to now, there have no clinical studies been published with regards to the Ankle Spacer.|
|- Brief summary||By means of the Ankle Spacer patients will be implanted, the clinical and radiological results of which will be prospectively recorded and analyzed at different points in time.|
|- Main changes (audit trail)|
|- RECORD||22-aug-2017 - 9-sep-2017|