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Not Yet Recruiting
NCT05655156
OrthoPureXT Multiligament PMCF Study
Conditions: Multiligament Knee Injuries
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 28
Sponsor: Tissue Regenix Ltd
Summary
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.
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 traumaNeurovascular emergenciesCompartment syndromeLife threatening injuryThose 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 fixatorsLocal severe concomitant injuriesInjuries to other parts of the body associated with a high level of daily activity/intervention for the patientThose 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 Visit1 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 surgeryPatients with known allergy, hypersensitivity, or religious objection to, implanted porcine materialPatients unable or unwilling to follow the post-operative care and rehabilitation programme
Source: ClinicalTrials.gov (NCT05655156). StuddyBuddy aggregates publicly available trial information.