Monitoring the safety and performance of OrthoPureXT for knee ligament injuries
Post Market Clinical Follow-Up of OrthoPureXT for the Treatment of Multiligament Injured Knee: a Case Series
This study is testing the safety and effectiveness of a new tissue product called OrthoPureXT for people getting knee ligament surgery to see how well it works and if there are any unexpected risks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tissue Regenix Ltd Industry-sponsored |
| Locations | 1 site (Stoke-on-Trent) |
| Trial ID | NCT05655156 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and performance of OrthoPureXT, a porcine tissue scaffold used in multi-ligament knee reconstructions. It aims to monitor any residual risks in the post-market phase and ensure that no new or unexpected risks arise from its use. A total of 28 patients will be enrolled, divided into sub-groups based on the specific ligaments being reconstructed, including the ACL, PCL, MCL, and LCL. Participants will undergo rehabilitation protocols to assess outcomes effectively.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with multiple knee ligament injuries.
Not a fit: Patients with severe concurrent injuries or those unable to provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of knee ligament reconstruction procedures.
How similar studies have performed: While this approach is being monitored in a post-market context, similar studies have shown promise in evaluating the safety of new surgical materials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stoke-on-Trent
- Royal Stoke University Hospital — Stoke-on-Trent, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Anna Kaniewska
- Email: a.kaniewska@tissueregenix.com
- Phone: +44 (0)3304303052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.