posttraumatic radiocarpal osteoarthritis wrist osteoarthritis
Conditions
Interventions
surgery performing interposition arthroplasty using the WISE implant for
Radiocarpal Interposition Arthroplasty.
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Signed and dated written informed consent prior to admission to the clinical study in accordance with good clinical practice (GCP) and local legislation; - Male >18 years of age and post menopausal females; - Diagnosed with posttraumatic radiocarpal osteoarthritis as diagnosed with an X-ray and/or CT scan of the wrist;
Exclusion criteria
Exclusion criteria: - Previous surgery for posttraumatic radiocarpal osteoarthritis, with in particular salvage procedures such as excisional arthroplasty (proximal row carpectomy), total wrist arthrodesis and total wrist arthroplasty; Prior reconstructive procedures are not exclusion criteria; - General objections for surgery, determined after anaesthesiologic assessment; - Radiocarpal osteoarthritis including the midcarpal joint; - Acute or chronic infection of the radiocarpal joint; - Diagnosed rheumatoid arthritis of the radiocarpal joint; - Unwilling to cooperate with the study protocol and follow up schedule; - Judged by the surgeon mentally incapable to follow study requirements; - Diagnosed with neuromuscular or neuro-sensory deficit which would limit the ability to assess the performance of the radiocarpal interposition arthroplasty; - Diagnosed with active malignancy;; - Known systemic or metabolic disorders leading to progressive bone deterioration; - Use of systemic corticosteroids within the last 3 months (inhaled steroids are no reason for exclusion); - Presence of an active or suspected infection; - Uncontrolled diabetes mellitus as determined by treating physicians;-contraindication for general anesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety of a patient-matched injection molded Bionate ® II 80A radiocarpal interposition arthroplasty implant in adult patients with posttraumatic radiocarpal osteoarthritis. Evaluation of the safety of the use of radiocarpal interposition arthroplasty implant will be performed throughout the clinical investigation by reporting the number of patients with adverse events (AE) observed during the study, and in specific AE timing, nature, severity and relatedness to the study device or procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the performance of a patient-matched injection molded Bionate ® II 80A radiocarpal interposition arthroplasty implant in patients with posttraumatic radiocarpal osteoarthritis. Evaluation of the performance of the radiocarpal interposition arthroplasty implant will be performed throughout clinical investigation by evaluating patient reported outcome measures (PROMs) for functional outcomes, pain, and functionality of the radiocarpal joints, measured as range of motion and grip strength. In addition, radiocarpal cartilage and luxation of the radiocarpal interposition arthroplasty implant will be evaluated by MRI. | — |
Countries
Netherlands
Contacts
Public ContactJ Gruisen
Maastricht Universitair Medisch Centrum +
Outcome results
None listed