Mg Wire for Augmentation of ACL Reconstruction

NCT05983692 | Not Yet Recruiting DMC

• 1 other identifier: 2021.654
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Anterior Cruciate Ligament Rupture

Keywords

ACLR; Mg wire; Bone tendon interface healing

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks and 3, 6, 12 and 24 months post-operation.

Secondary Outcomes (6)

• International Knee Documentation Committee

  Pre-operation, 2 weeks and 3, 6, 12 and 24 months post-operation.

• Tegner activity score

  Pre-operation, 2 weeks and 3, 6, 12 and 24 months post-operation.

• Passive Knee laxity

  3, 6, 12 and 24 months post-operation.

• Isokinetic muscle strength

  3, 6, 12 and 24 months post-operation

• Cytokines assay

  Pre-operation, Day 1, 2 and 6 weeks and 3 months post-operation

Study Arms (2)

Mg Wire group

EXPERIMENTAL

Intervention: Magnesium-based wire as braiding suture to braid the tendon graft.

Device: Magnesium based wire

control group

NO INTERVENTION

2-0 vicryl suture as control, size and length matched Mg wire

Interventions

Magnesium based wire DEVICE

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

Mg Wire group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-40
• Unilateral ACL tear for primary ACLR (Single bundle, Hamstring) confirmed clinically and radiologically.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Alice Ho Miu Ling Nethersole Hospital: collaborator
• Kwong Wah Hospital: collaborator
• Tseung Kwan O Hospital, Hong Kong: collaborator

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

Michael Tim-Yun Ong

CONTACT

055699059; michael.ong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 9, 2023
• Study Start: June 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: Journal reviewers

Locations

HK (1)