Wrist implant safety evaluation (WISE) study

Recruiting

• Conditions: posttraumatic radiocarpal osteoarthritis; 10023213

• Registration Number: NL-OMON56094
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 12

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

- 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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>safety of a patient-matched injection molded Bionate ® II 80A radiocarpal<br /><br>interposition arthroplasty implant in adult patients with posttraumatic<br /><br>radiocarpal osteoarthritis.<br /><br><br /><br>Evaluation of the safety of the use of radiocarpal interposition arthroplasty<br /><br>implant will be performed throughout the clinical investigation by reporting<br /><br>the number of patients with adverse events (AE) observed during the study, and<br /><br>in specific AE timing, nature, severity and relatedness to the study device or<br /><br>procedure. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the performance of a patient-matched injection molded Bionate ® II<br />80A radiocarpal interposition arthroplasty implant in patients with<br />posttraumatic radiocarpal osteoarthritis.<br /><br />Evaluation of the performance of the radiocarpal interposition arthroplasty<br />implant will be performed throughout clinical investigation by evaluating<br />patient reported outcome measures (PROMs) for functional outcomes, pain, and<br />functionality of the radiocarpal joints, measured as range of motion and grip<br />strength. In addition, radiocarpal cartilage and luxation of the radiocarpal<br />interposition arthroplasty implant will be evaluated by MRI.</p>