Wrist repair in severe trauma (WRIST) study

Withdrawn

Conditions: 10023213
10005944
post traumatic wrist osteo-arthritis
wear and tear of wrist after injury
10005942

Registration Number: NL-OMON43869

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 12

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 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The objective of this study is to investigate whether reconstruction of the<br /><br>radiocarpal joint by implantation of a tailor-made and patient specific 3D<br /><br>printed interpositional arthroplasty made out of Bionate® II 80A PCU (DSM®) is<br /><br>feasible as a therapy in patients with severe posttraumatic radiocarpal<br /><br>osteoarthritis.<br /><br>The feasibility will be measured in by evaluation of the position, aspect,<br /><br>degree of wear and tear and eventual (dis)location of the Bionate® II<br /><br>interpositional arthroplasty. The evaluation will be done by magnetic resonance<br /><br>imaging (MRI) of the wrist at different time points in follow-up after<br /><br>implantation.<br /><br>Eventual negative side-effects of implantation of a Bionate® II PCU sheet in<br /><br>the radiocarpal joint will be registered.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Next to radiological evaluation of the feasibility, clinical and functional<br /><br>outcomes will be assessed as well. We will investigate the effect of the<br /><br>Bionate® II interpositional arthroplasty on functionallity of the radiocarpal<br /><br>joints, measured as range of motion and grip strength of the affected wrist<br /><br>compared to baseline. We will assess the functional outcome and pain as<br /><br>measured with the PRWHE, SF36 and EQ5D questionnaires. We will determine the<br /><br>functional outcome at four different time points in follow-up after<br /><br>implantation, compared to the situation prior to surgery. Eventually we want to<br /><br>investigate whether the Bionate® II interpositional arthroplasty can serve as a<br /><br>better alternative for severe posttraumatic degenerative wrist conditions than<br /><br>excisional arthroplasty or wrist arthrodesis.</p><br>