Ignite Creation Date:
2024-05-06 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05983692
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2023-07-31
Brief Title:
Mg Wire for Augmentation of ACL Reconstruction
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Clinical Translation of Biodegradable Magnesium Wire for Augmentation of Anterior Cruciate Ligament ACL Reconstruction From Bench Side to Bedside A Multicentre Double-blinded Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background ACLR with autologous tendon graft is commonly used for the treatment of ACL injury However as the BTI healing is poor this can lead to a failure rate of 5 in the first-year post-operation a long and unpredictable rehabilitation period is expected and 35 of patients never return to preinjury level of sports Biological enhancement of BTI healing will help to cut down the medical cost related to poor prognosis As a biodegradable metal Mg has been developed as implants in orthopaedics for decades yet without clinical implants developed for ACLR Our team has been working on this area in the past 10 years preclinically Our animal studies showed that supplementation of magnesium wire significantly promotes osteogenesis at BTI and improves mechanical strength in ACLR Recently our team developed a highly pure 9999 Mg wire Fig 2 in collaboration with metallic engineers for tendon graft braiding during ACLR and with its improved physical quality and strength it is suitable for graft braiding and then its degradation in vivo can promote tunnel bone formation and bone tendon interface integration
Objective To investigate if anterior cruciate ligament ACL reconstruction augmented with magnesium Mg wire enhances osteogenesis at the bone-tendon interface BTI improving post-op rehabilitation and leading to better clinical outcomes
Hypothesis Patients with ACL reconstruction using Mg wire will experience improved osteogenesis at the BTI more effective rehabilitation and superior knee strength and function
Design and Subjects A multicentre double-blinded randomized controlled trial will recruit patients aged 18-30 with unilateral ACL tear for primary ACLR with a hamstring graft at four sites
Instruments Mg-based wire
Interventions Participants will receive either 9999 purity Mg wire or 2-0 vicryl as a control
Main Outcomes Osteogenesis will be assessed by High-Resolution Peripheral Quantitative Computed Tomography HR-pQCT muscle strength via Biodex tests and functional recovery with International Knee Documentation Committee IKDC and Tegner scores at multiple post-op intervals Knee stability will be checked with KT-1000 arthrometer Blood samples will be analyzed for inflammatory markers and metabolic effects related to Mg wire
Data Analysis and Expected Results A repeated-measures ANOVA will be utilized for data analysis The expectation is that Mg wire augmentation will significantly enhance osteogenesis at the BTI and improve rehabilitation outcomes
Objective To investigate if anterior cruciate ligament ACL reconstruction augmented with magnesium Mg wire enhances osteogenesis at the bone-tendon interface BTI improving post-op rehabilitation and leading to better clinical outcomes
Hypothesis Patients with ACL reconstruction using Mg wire will experience improved osteogenesis at the BTI more effective rehabilitation and superior knee strength and function
Design and Subjects A multicentre double-blinded randomized controlled trial will recruit patients aged 18-30 with unilateral ACL tear for primary ACLR with a hamstring graft at four sites
Instruments Mg-based wire
Interventions Participants will receive either 9999 purity Mg wire or 2-0 vicryl as a control
Main Outcomes Osteogenesis will be assessed by High-Resolution Peripheral Quantitative Computed Tomography HR-pQCT muscle strength via Biodex tests and functional recovery with International Knee Documentation Committee IKDC and Tegner scores at multiple post-op intervals Knee stability will be checked with KT-1000 arthrometer Blood samples will be analyzed for inflammatory markers and metabolic effects related to Mg wire
Data Analysis and Expected Results A repeated-measures ANOVA will be utilized for data analysis The expectation is that Mg wire augmentation will significantly enhance osteogenesis at the BTI and improve rehabilitation outcomes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None