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Recruiting Not applicable

OrthoPureXT Multiligament PMCF Study

NCT05655156 · tracked via the Priya Life Science UK tracker
Sponsor
Tissue Regenix Ltd
Phase
Not applicable
Started
2025-04
Last updated
2025-04-15

Condition(s) studied

Multiligament Knee Injuries

Investigational drug(s) / intervention(s)

OrthoPure XT

OrthoPure XT: Indication: reconstruction of knee ligaments to restore knee function and stability The following device sizes are available for use in this indication: * Size 5 \- Multi-ligament reconstruction (recommended for extra-articular ligament reconstruction) * Size 6 \- Multi-ligament reconstruction (recommended for extra-articular ligament reconstruction) * Size 8 * Primary ACL reconstruction where autograft tissue is not suitable * Revision ACL reconstruction * Multi-ligament reconstruction (recommended for extra-articular ligament reconstruction) * Size 10 * Multi-ligament reconstruction (recommended for posterior cruciate ligament (PCL) reconstruction)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • A change from Baseline in IKDC — Baseline (30 days prior to surgery); 1, 3, 6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up)
    Assessment of knee stability via evaluation of IKDC score.

Trial sites (1)

FacilityCityRegionStatus
Royal Stoke University Hospital Stoke-on-Trent United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05655156 on ClinicalTrials.gov ↗ ← All trials in the UK