Actively Recruiting
OrthoPureXT Multiligament PMCF Study
Led by Tissue Regenix Ltd · Updated on 2025-04-15
28
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
OrthoPureXT Multiligament PMCF Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Unable to give consent.
- Conflicting variables such as open trauma, neurovascular emergencies, compartment syndrome, or life threatening injury.
- Physical barriers including associated fractures requiring external fixators, severe local injuries, or injuries to other body parts that require high levels of care.
- Considered a poor candidate for surgery by the investigator.
- If female and of child-bearing potential, positive pregnancy test or intention to become pregnant within 12 months.
- Contraindications including signs of infection within 24 hours prior to surgery.
- Known allergy, hypersensitivity, or religious objection to implanted porcine material.
- Unable or unwilling to follow post-operative care and rehabilitation program.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom, ST4 6QG
Actively Recruiting
Research Team
A
Anna Kaniewska
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here