Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536660
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-26
Brief Title:
Biodegradable Magnesium Bone Plate and Screw Fixation in Jaw Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Application of Biodegradable Magnesium Bone Plate and Screw Fixation in Jaw Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MgJawSurgery
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 these biodegradable magnesium devices promote normal bone healing and functional recovery while ensuring the safety of patients undergoing dentoalveolar surgery fracture fixation orthognathic surgery or craniofacial reconstruction The hypotheses are
1 High-purity magnesium bone plates and screws are effective in bone fixation promoting normal bone healing and functional recovery in jaw surgery
2 High-purity magnesium bone plates and screws are safe in jaw surgery in terms of local side effects and systemic safety
Participants will undergo jaw surgery based on the clinical indications High-purity magnesium bone plates and screws will be used for internal fixation during the surgical procedure Participants will be followed up at 1 week 3 weeks 6 weeks 3 months 6 months 1 year and 2 years after surgery to assess wound healing functional recovery and any side effects If any side effects occur or deemed necessary participants may be followed up for a longer period During postoperative follow-up visits X-ray or CBCTCT imaging will be conducted routinely or when clinically indicated
1 High-purity magnesium bone plates and screws are effective in bone fixation promoting normal bone healing and functional recovery in jaw surgery
2 High-purity magnesium bone plates and screws are safe in jaw surgery in terms of local side effects and systemic safety
Participants will undergo jaw surgery based on the clinical indications High-purity magnesium bone plates and screws will be used for internal fixation during the surgical procedure Participants will be followed up at 1 week 3 weeks 6 weeks 3 months 6 months 1 year and 2 years after surgery to assess wound healing functional recovery and any side effects If any side effects occur or deemed necessary participants may be followed up for a longer period During postoperative follow-up visits X-ray or CBCTCT imaging will be conducted routinely or when clinically indicated
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 development titanium and its alloys have become the predominant materials for internal fixation owing to their exceptional mechanical properties and biocompatibility However titanium has certain drawbacks such as excessive rigidity compared to bone which can result in stress shielding and subsequent bone resorption Additionally titanium plate and screw fixation is intended for temporary mechanical support during bone healing and may necessitate removal via a secondary surgery following bone healing thereby increasing healthcare burdens If left in situ titanium can interfere with X-ray imaging due to beam-hardening effects
In an effort to address the limitations of titanium fixation researchers have been exploring the development of alternative materials for internal fixation Bioresorbable systems utilize biodegradable materials for bone plate and screw fixation thus eliminating the need for a secondary surgery for hardware removal These biodegradable systems avoid long-term issues associated with stress shielding or X-ray scattering Commercially available biodegradable osteosynthesis materials include high-molecular-weight polymers such as polylactic acid PLA polyglycolic acid PGA and polylactic-co-glycolic acid copolymer PLGA However these biodegradable polymers exhibit insufficient mechanical strength necessitating increased dimensions and resulting in a bulky volume that may impede application Moreover the suboptimal biocompatibility can provoke foreign body reactions and hinder normal bone healing Lastly controlling the biodegradation rates of polymers is challenging which may surpass normal bone healing and lead to postoperative complications such as malunion or nonunion
In recent years magnesium has emerged as a promising biodegradable metal for internal fixation as demonstrated by numerous research studies Magnesium exhibits mechanical properties more closely aligned with human bone than the rigid titanium or stainless-steel materials effectively mitigating the drawbacks of stress shielding and X-ray scattering In vivo magnesium plates and screws gradually dissolve releasing magnesium ions and hydrogen gas Magnesium ions essential to the human body can be metabolized without causing harm The accumulation of hydrogen gas in tissues may result in temporary swelling or discomfort which typically resolves as the gas dissipates over time More importantly magnesium has demonstrated remarkable bioactivity in promoting bone regeneration sparking a surge of interest in basic biomechanical research Its exceptional bioactivity has even been demonstrated in challenging clinical situations Consequently the unique and superior properties of magnesium have positioned it as a promising next-generation biomedical implants for internal fixation in humans
The application of magnesium-based materials in bone surgery can be traced back to 1906 and recent advancements have led to the development of biodegradable internal fixation devices by companies like Synntellix AG Germany and UI Corporation South Korea 7 These fixation systems including MAGNEZIX Mg-Y-Re-Zr alloy screws and RESOMET Mg-Ca-Zn alloy screws have shown promising results in various clinical studies across multiple countries treating conditions such as hallux valgus osteonecrosis of the femoral head and distal radius fractures However given the potential health risks of alloy elements to patients Chinese research teams have been committed to the development of high-purity magnesium for internal fixation purposes
Numerous human clinical studies utilizing high-purity magnesium have been successfully conducted in China In 2015 Yu et al employed high-purity magnesium screws for the fixation of vascularized bone grafts in young adults with displaced femoral neck fractures Over a 16-month follow-up period patients achieved satisfactory results in the Harris hip score a functional index and experienced a lower incidence of complications such as avascular necrosis and nonunion In 2016 Zhao et al implemented high-purity magnesium screws in a clinical trial to fix vascularized bone grafts in osteonecrosis of the femoral head Within a 12-month follow-up period patients treated with magnesium screws demonstrated higher satisfactory results in functional scores and reduced bone graft displacement The serum levels of magnesium remained within the normal physiological range and potential adverse effects induced by magnesium degradation products were absent In 2019 Chen et al utilized high-purity magnesium screws to fix vascularized bone grafts for trauma-induced femoral head necrosis in a case report Satisfactory outcomes were achieved in terms of functional recovery and the magnesium screws gradually degraded over more than two years without any noticeable side effects
Despite its potential magnesium-based fixation faces challenges in orthopedics due to its relatively weak mechanical strength when used in weight-bearing areas and no clinical trials have been conducted in such cases thus far Theoretically fixation in the hip joint area must withstand forces exceeding 2000N or three times the body weight which may increase during functional mobilization Researchers have been exploring coating strategies to decelerate the in vivo degradation of magnesium thereby extending the mechanical support for adequate orthopedic healing They are also investigating metallurgical techniques to enhance the mechanical strength of magnesium fixation devices Conversely jaw surgeries may benefit from magnesium-based fixation due to their comparatively lower force-loading requirements compared to limb or spine fixation The normal forces for the mandible are approximately 400N which decrease to 115N at one week and 250N at six weeks after internal reduction Consequently magnesium fixation holds promise for successful application in jaw surgery
Nonetheless owing to limited clinical research in this domain considerable efforts are needed to thoroughly comprehend the benefits of magnesium-based materials in jaw surgery and to establish novel surgical protocols for their implementation This study seeks to investigate the application of magnesium for bone fixation in jaw surgery and to comprehensively assess the surgical outcomes The study will contribute to a deeper understanding of using magnesium as internal fixation in jaw surgery and is expected to pave the way for new surgical protocols utilizing biodegradable fixation Ultimately this could lead to improved patient outcomes and a reduction in healthcare burdens
In an effort to address the limitations of titanium fixation researchers have been exploring the development of alternative materials for internal fixation Bioresorbable systems utilize biodegradable materials for bone plate and screw fixation thus eliminating the need for a secondary surgery for hardware removal These biodegradable systems avoid long-term issues associated with stress shielding or X-ray scattering Commercially available biodegradable osteosynthesis materials include high-molecular-weight polymers such as polylactic acid PLA polyglycolic acid PGA and polylactic-co-glycolic acid copolymer PLGA However these biodegradable polymers exhibit insufficient mechanical strength necessitating increased dimensions and resulting in a bulky volume that may impede application Moreover the suboptimal biocompatibility can provoke foreign body reactions and hinder normal bone healing Lastly controlling the biodegradation rates of polymers is challenging which may surpass normal bone healing and lead to postoperative complications such as malunion or nonunion
In recent years magnesium has emerged as a promising biodegradable metal for internal fixation as demonstrated by numerous research studies Magnesium exhibits mechanical properties more closely aligned with human bone than the rigid titanium or stainless-steel materials effectively mitigating the drawbacks of stress shielding and X-ray scattering In vivo magnesium plates and screws gradually dissolve releasing magnesium ions and hydrogen gas Magnesium ions essential to the human body can be metabolized without causing harm The accumulation of hydrogen gas in tissues may result in temporary swelling or discomfort which typically resolves as the gas dissipates over time More importantly magnesium has demonstrated remarkable bioactivity in promoting bone regeneration sparking a surge of interest in basic biomechanical research Its exceptional bioactivity has even been demonstrated in challenging clinical situations Consequently the unique and superior properties of magnesium have positioned it as a promising next-generation biomedical implants for internal fixation in humans
The application of magnesium-based materials in bone surgery can be traced back to 1906 and recent advancements have led to the development of biodegradable internal fixation devices by companies like Synntellix AG Germany and UI Corporation South Korea 7 These fixation systems including MAGNEZIX Mg-Y-Re-Zr alloy screws and RESOMET Mg-Ca-Zn alloy screws have shown promising results in various clinical studies across multiple countries treating conditions such as hallux valgus osteonecrosis of the femoral head and distal radius fractures However given the potential health risks of alloy elements to patients Chinese research teams have been committed to the development of high-purity magnesium for internal fixation purposes
Numerous human clinical studies utilizing high-purity magnesium have been successfully conducted in China In 2015 Yu et al employed high-purity magnesium screws for the fixation of vascularized bone grafts in young adults with displaced femoral neck fractures Over a 16-month follow-up period patients achieved satisfactory results in the Harris hip score a functional index and experienced a lower incidence of complications such as avascular necrosis and nonunion In 2016 Zhao et al implemented high-purity magnesium screws in a clinical trial to fix vascularized bone grafts in osteonecrosis of the femoral head Within a 12-month follow-up period patients treated with magnesium screws demonstrated higher satisfactory results in functional scores and reduced bone graft displacement The serum levels of magnesium remained within the normal physiological range and potential adverse effects induced by magnesium degradation products were absent In 2019 Chen et al utilized high-purity magnesium screws to fix vascularized bone grafts for trauma-induced femoral head necrosis in a case report Satisfactory outcomes were achieved in terms of functional recovery and the magnesium screws gradually degraded over more than two years without any noticeable side effects
Despite its potential magnesium-based fixation faces challenges in orthopedics due to its relatively weak mechanical strength when used in weight-bearing areas and no clinical trials have been conducted in such cases thus far Theoretically fixation in the hip joint area must withstand forces exceeding 2000N or three times the body weight which may increase during functional mobilization Researchers have been exploring coating strategies to decelerate the in vivo degradation of magnesium thereby extending the mechanical support for adequate orthopedic healing They are also investigating metallurgical techniques to enhance the mechanical strength of magnesium fixation devices Conversely jaw surgeries may benefit from magnesium-based fixation due to their comparatively lower force-loading requirements compared to limb or spine fixation The normal forces for the mandible are approximately 400N which decrease to 115N at one week and 250N at six weeks after internal reduction Consequently magnesium fixation holds promise for successful application in jaw surgery
Nonetheless owing to limited clinical research in this domain considerable efforts are needed to thoroughly comprehend the benefits of magnesium-based materials in jaw surgery and to establish novel surgical protocols for their implementation This study seeks to investigate the application of magnesium for bone fixation in jaw surgery and to comprehensively assess the surgical outcomes The study will contribute to a deeper understanding of using magnesium as internal fixation in jaw surgery and is expected to pave the way for new surgical protocols utilizing biodegradable fixation Ultimately this could lead to improved patient outcomes and a reduction in healthcare burdens
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None