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โ† Trials
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OrthoPureXT Multiligament PMCF Study

RecruitingNAAges 18 Years - anyAllTissue Regenix Ltd
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In plain words

What the trial is, and whether it could suit you

To monitor residual risks in the post-market phase and to ensure continued clinical evaluation of the device safety and performance to ensure that no new or unexpected risks arise when used during multi-ligament knee reconstructions.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male and female patients aged 18 years old or above. * Adults suffering with multiple knee ligament injuries. * Ability to communicate meaningfully with investigative staff, competence to give written informed consent; and willingness and ability to comply with entire study procedures including rehabilitation protocol. Exclusion Criteria: * Those unable to give consent. * Those considered as conflicting variables by the investigator. This may include, but is not limited to: * Open trauma * Neurovascular emergencies * Compartment syndrome * Life threatening injury * Those considered as physical barriers by the investigator, preventing physical or ethical collection of study data. This may include, but is not limited to: * Associated fractures that require external fixators * Local severe concomitant injuries * Injuries to other parts of the body associated with a high level of daily activity/intervention for the patient * Those considered as a poor candidate for surgery by the investigator. * If female and of child-bearing potential must not have a positive pregnancy test at Visit 1 nor have a stated intention to become pregnant in the next 12 months. * Those patients contraindicated for in the IFU, i.e.: * Showing signs of infection within 24 hours prior to surgery * Patients with known allergy, hypersensitivity, or religious objection to, implanted porcine material * Patients unable or unwilling to follow the post-operative care and rehabilitation programme
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What it tests

  • OrthoPure XT
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Where

1 site
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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