Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT05655156
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05655156
Study Brief:
Protocol Section:
NCT05655156