๐ฌIn 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.
๐ 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
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
๐ค 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.