post traumatic wrist osteo-arthritis wear and tear of wrist after injury
Conditions
Interventions
An interpositional artroplasty is performed by inserting a small Bionate® II
PCU sheet in the radiocarpal joint via a limited dorsal wrist arthrotomy. This
procedure will be performed under general
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients over 18 years of age with severe post traumatic radio carpal osteo-arthritis with an indication for excision arthroplasty, arthrodesis or wrist arthroplasty will be eligible for inclusion
Exclusion criteria
Exclusion criteria: Exclusion criteria are previous surgery for severe post traumatic radiocarpal conditions, especially salvage procedures (such as excisional artroplasty, arthrodesis) and general objections for surgery, determined after anaesthesiological assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of this study is to investigate whether reconstruction of the radiocarpal joint by implantation of a tailor-made and patient specific 3D printed interpositional arthroplasty made out of Bionate® II 80A PCU (DSM®) is feasible as a therapy in patients with severe posttraumatic radiocarpal osteoarthritis. The feasibility will be measured in by evaluation of the position, aspect, degree of wear and tear and eventual (dis)location of the Bionate® II interpositional arthroplasty. The evaluation will be done by magnetic resonance imaging (MRI) of the wrist at different time points in follow-up after implantation. Eventual negative side-effects of implantation of a Bionate® II PCU sheet in the radiocarpal joint will be registered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Next to radiological evaluation of the feasibility, clinical and functional outcomes will be assessed as well. We will investigate the effect of the Bionate® II interpositional arthroplasty on functionallity of the radiocarpal joints, measured as range of motion and grip strength of the affected wrist compared to baseline. We will assess the functional outcome and pain as measured with the PRWHE, SF36 and EQ5D questionnaires. We will determine the functional outcome at four different time points in follow-up after implantation, compared to the situation prior to surgery. Eventually we want to investigate whether the Bionate® II interpositional arthroplasty can serve as a better alternative for severe posttraumatic degenerative wrist conditions than excisional arthroplasty or wrist arthrodesis. | — |
Countries
Netherlands
Outcome results
None listed