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.
ID
Bron
Verkorte titel
Aandoening
osteochondral defects of the talus
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary study parameter is the measurement of the NRS pain during walking/normal weight-bearing.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
pre-operatively
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
Onderzoeksproduct en/of interventie
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.
Publiek
Jari Dahmen
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31(0)205662472
j.dahmen@amc.uva.nl
Wetenschappelijk
Jari Dahmen
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31(0)205662472
j.dahmen@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-severe ankle malalignement.(> 5° varus/valgus).
-fracture < 6 months - tendinitis - diabetes mellitus / reumathoid arthritis
-advanced osteoporosis
-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)
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6477 |
| NTR-old | NTR6664 |
| CCMO | NL62466.018.17 |
| OMON | NL-OMON44464 |