Status:
NOT_YET_RECRUITING
Biodegradable Magnesium Bone Plate and Screw Fixation in Jaw Surgery
Lead Sponsor:
The University of Hong Kong
Conditions:
Orthognathic Surgical Procedures
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of using high-purity magnesium bone plates and screws for internal fixation in jaw surgery. The investigators aim to assess whether the...
Detailed Description
Bone plate and screw fixation is a well-recognized system for internal fixation in jaw surgery, encompassing fracture fixation, orthognathic surgery, and craniofacial reconstruction. Along the develop...
Eligibility Criteria
Inclusion
- Participants must be 18 years of age or older.
- Participants must have confirmed indications for jaw surgery with internal fixation, such as alveolar onlay bone grafting, fracture fixation, orthognathic surgery, or reconstructive surgery.
- Participants should have adequate bone quality and sufficient bone volume to support the placement of magnesium bone plates and screws.
- Participants must provide written informed consent, indicating their understanding of the potential risks and benefits of magnesium bone plate and screw fixation.
Exclusion
- Participants with certain medical conditions that may affect bone healing or increase the risk of complications, such as uncontrolled diabetes, severe osteoporosis, multiple myelomas, or active bone infections.
- Participants with medical conditions that may exacerbate or predispose them to systemic side effects of magnesium implants, thus contraindicating their use, should be excluded. These conditions include chronic kidney disease, hypermagnesemia, severe electrolyte imbalances, severe heart disease (especially in those with a history of arrhythmias or heart failure), myasthenia gravis, abnormal thyroid functions, hyperparathyroidism, and adrenocortical insufficiency.
- Participants with known allergies or hypersensitivity to magnesium.
- Participants with an ASA score of 3 or above, indicating a higher risk for general anesthesia.
- Participants who are pregnant or breastfeeding.
- Participants deemed unlikely to comply with the study protocol, such as attending follow-up appointments or adhering to post-operative care instructions.
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2028
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06536660
Start Date
August 15 2024
End Date
August 15 2028
Last Update
August 5 2024
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