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A Multi-centre, Double-blind RCT to Investigate the Effect of Alendronate on Knee Function Following ACLR

RecruitingPhase 4Ages 14 Years - anyAllChinese University of Hong Kong
NCT05527548 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Anterior cruciate ligament (ACL) is the key ligament connecting the femur to tibia that helps stabilising the knee joint. ACL tear is common. It accounts for over 50% of all knee injuries and affects more than 200,000 people in the United States each year. Patients with ACL tear have a higher risk of developing post-traumatic osteoarthritis. ACL reconstruction (ACLR) with the attachment of tendon grafts within bone tunnels are commonly performed to restore the stability of the joint and thereby minimise injury to both the chondral surface and surrounding tissues. About 130,000 ACLR was performed in the United States in 2006. Both the incidence rates of ACL injuries and ACLR are on the rise, particularly in children and adolescents. Conventional ACLR is not a universally successful procedure, with long healing time and high rates of graft failure (2.8%) and graft laxity (18%). The average

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male and female with age 14 or above at the time of surgery * First ACLR * Single leg involvement * Able to attend pre-operative assessment * Voluntarily agreed to participate and signed the informed consent form Exclusion Criteria: * Known chronic disease or receiving long-term medications affecting bone metabolism including BPs * Contraindication to alendronate therapy such as poor dental fitness * ACL injury less than 6 weeks * Injury on duty cases * Patients who have undergone arthroscopy or open surgery in the index knee in the last 12 months * Other associated injuries (fractures and other ligament involvement such as neurovascular bundles injury) * Chondral lesion with concomitant intervention * Presence of X-ray features of osteoarthritis including decrease in joint space, presence of osteophytes and subchondral cysts * Neurological deficit * Pregnant or breastfeeding * Inability to give informed consent
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What it tests

  • Alendronate (ALN)
  • Placebo
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Where

1 site
Prince of Wales Hospital
Shatin, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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