Anterior Cruciate Ligament RuptureNCT05983692
Mg Wire for Augmentation of ACL Reconstruction
A study testing Magnesium based wire in people with Anterior Cruciate Ligament Rupture, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Magnesium based wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-40
- Unilateral ACL tear for primary ACLR (Single bundle, Hamstring) confirmed clinically and radiologically.
Who cannot join
- Concomitant multiple ligament injuries requiring additional surgical procedures,
- Preoperative radiographic signs of arthritis,
- Revision ACLR
- Femoral tunnel interference screws
- Contralateral knee with ACL deficiency or reconstruction
- Medical co-morbidities
- Long-term steroid intake
- Non-compliance to our rehabilitation protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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 (99.99%) 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.
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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 99.99% 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.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Magnesium based wire
- Keywords
- ACLR, Mg wire, Bone tendon interface healing
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium based wireDevice
Mg wire will be used as a braiding suture to braid tendon graft, which is a standard preparation of graft and is not related to fixation of the tendon graft
| Study group | Role | What they receive |
|---|---|---|
| Mg Wire group | Experimental | Intervention: Magnesium-based wire as braiding suture to braid the tendon graft. Receives: Device: Magnesium based wire |
| control group | No intervention | 2-0 vicryl suture as control, size and length matched Mg wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone shell size
HR-pQCT (ExtremCT II, Scanco, Switzerland) will be used to measure the bone shell size at graft tunnel interface. The involved knees will be investigated. A total of 1344 axial slices with an image matrix of 2304 × 2304 were collected at a nominal isotropic voxel size of 60.7μm. The scan region was defined by the scout view image acquired in the sagittal plane.The total scanning length was 81.6mm which covered the tunnel from proximal tibia to distal femoral condyle (X-ray settings: 68kVp, 1470μA, 100ms integration time, 156mAs per stack (168 slices).Image segmentation will be performed to select the bone shell features at graft tunnel interfaces near femoral and tibial intra-articular apertures with standardized threshold values at a thickness of ~2.5 mm (40 slices). Geometric transformation will be performed to adjust for the variations in angle between scanning axis and tunnel axis by a cosine function.
Measured: 2 weeks and 3, 6, 12 and 24 months post-operation.
Secondary outcomes (6)
International Knee Documentation Committee
Consists of 10 questions on symptoms and activity ranging from 0 to 100 where 100 implies perfect knee function.
Measured: Pre-operation, 2 weeks and 3, 6, 12 and 24 months post-operation.
Tegner activity score
This is an activity level scaled from 1 (low activity) to 10 (high activity).
Measured: Pre-operation, 2 weeks and 3, 6, 12 and 24 months post-operation.
Passive Knee laxity
To measure anterior-posterior knee laxity, the KT-1000 knee ligament arthrometer (MEDmetric Corp, San Diego, CA, USA) will be used. A manual force test will be applied until a 30lb sound signal is activated. Three trials will be performed. A side difference of 3 mm above is considered clinically relevant.
Measured: 3, 6, 12 and 24 months post-operation.
Isokinetic muscle strength
The dynamometer (Biodex System 4, Biodex Medical Systems Inc., New York, USA) will be used for measuring Isokinetic muscle strength in N. Subjects will perform a standardized warm-up exercise (5 min cycling) followed by the test. Concentric/concentric contractions of knee extension/flexion will be tested at 60°/s and 180°/s. Subjects will be seated on the dynamometer chair with their hips flexed to 85°.
Measured: 3, 6, 12 and 24 months post-operation
Cytokines assay
To evaluate the safety of Mg wire with respect to inflammatory responses, 5 ml blood samples will be collected for C-reactive protein measurement using ELISA kit.
Measurements of Ca, Mg, P, Cr, Urea, ALT, AST, TP, ALB, GLB will be taken to monitorpotential effect of the Mg wire. The blood tests will be performed at baseline, day 1 post-op, 2 weeks, 6 weeks and 12 weeks post-op, since the degradation of Mg wire is faster based on our preclinical study results.
Measured: Pre-operation, Day 1, 2 and 6 weeks and 3 months post-operation
Single leg hop distance
The average of single leg hop distance in cm with three attempts will be measured during the single leg hop test.
Measured: 6, 12 and 24 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study startJun 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Alice Ho Miu Ling Nethersole Hospital, Kwong Wah Hospital, Tseung Kwan O Hospital, Hong Kong
- Responsible party
- Principal investigator, Prof. Tim-Yun Michael ONG, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983692
- Sponsor's protocol ID
- 2021.654
- Status last verified
- Feb 2024
- First submitted
- 31 Jul 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05983692
- Acronym / sponsor ID
- 2021.654
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- ACLR, Mg wire, Bone tendon interface healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Alice Ho Miu Ling Nethersole Hospital, Kwong Wah Hospital, Tseung Kwan O Hospital, Hong Kong
- Study start
- Jun 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (99.99%) 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 99.99% 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mg Wire group | Experimental | Device: Magnesium based wireIntervention: Magnesium-based wire as braiding suture to braid the tendon graft. |
| control group | No intervention | –2-0 vicryl suture as control, size and length matched Mg wire |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-40
- Unilateral ACL tear for primary ACLR (Single bundle, Hamstring) confirmed clinically and radiologically.
Key exclusion criteria (8 listed)
- Concomitant multiple ligament injuries requiring additional surgical procedures,
- Preoperative radiographic signs of arthritis,
- Revision ACLR
- Femoral tunnel interference screws
- Contralateral knee with ACL deficiency or reconstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium based wireMg wire will be used as a braiding suture to braid tendon graft, which is a standard preparation of graft and is not related to fixation of the tendon graft | Device | Mg Wire group |
Primary outcome
Bone shell size
Time frame: 2 weeks and 3, 6, 12 and 24 months post-operation.
HR-pQCT (ExtremCT II, Scanco, Switzerland) will be used to measure the bone shell size at graft tunnel interface. The involved knees will be investigated. A total of 1344 axial slices with an image matrix of 2304 × 2304 were collected at a nominal isotropic voxel size of 60.7μm. The scan region was defined by the scout view image acquired in the sagittal plane.The total scanning length was 81.6mm which covered the tunnel from proximal tibia to distal femoral condyle (X-ray settings: 68kVp, 1470μA, 100ms integration time, 156mAs per stack (168 slices).Image segmentation will be performed to select the bone shell features at graft tunnel interfaces near femoral and tibial intra-articular apertures with standardized threshold values at a thickness of ~2.5 mm (40 slices). Geometric transformation will be performed to adjust for the variations in angle between scanning axis and tunnel axis by a cosine function.
6 secondary outcomes
International Knee Documentation Committee
Time frame: Pre-operation, 2 weeks and 3, 6, 12 and 24 months post-operation.
Tegner activity score
Time frame: Pre-operation, 2 weeks and 3, 6, 12 and 24 months post-operation.
Passive Knee laxity
Time frame: 3, 6, 12 and 24 months post-operation.
Isokinetic muscle strength
Time frame: 3, 6, 12 and 24 months post-operation
Cytokines assay
Time frame: Pre-operation, Day 1, 2 and 6 weeks and 3 months post-operation
Single leg hop distance
Time frame: 6, 12 and 24 months post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium based wire in people with Anterior Cruciate Ligament Rupture, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Tim-Yun Ong (055699059, michael.ong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone shell size (time frame: 2 weeks and 3, 6, 12 and 24 months post-operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.