OrthoPureXT Multiligament PMCF Study
Post Market Clinical Follow-Up of OrthoPureXT for the Treatment of Multiligament Injured Knee: a Case Series
Tissue Regenix Ltd
28 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria17
- 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
- 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
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Interventions
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)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05655156