Observational post-market surveillance registry including subjects treated with biodegradable magnesium-based implants specific for the intended use
- Conditions
- All MAGNEZIX® implants with marketing approval. Conditions strictly follow the instructions for use (IFU)
- Registration Number
- DRKS00022381
- Lead Sponsor
- Syntellix AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
Indication for treatment with MAGNEZIX® product according to the IFU.
- Age = 18 years.
- Written informed consent for all individual patient data entered into the database.
Exclusion Criteria
- Exclusion according to the IFU.
- Known allergies against any components of the implant.
- Participation in an interventional orthopedic or surgical trial prior to surgery.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety:<br>- Adverse device effect (ADE) during surgery.<br>- ADE during wound healing, e.g., infection, screw fracture or delayed wound healing.<br>- Revision surgery up to 1-year follow-up postoperatively.<br>- ADE, such as implant-related complication up to 5 years follow-up.<br>- Serious adverse event (SAE) up to 1-year follow-up.<br>- Serious adverse device effect (SADE) up to 5 years follow-up.<br>- Unanticipated SADE (USADE) up to 5 years follow-up.
- Secondary Outcome Measures
Name Time Method