OrthoPureXT Multiligament PMCF Study
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Royal Stoke University Hospital | Stoke-on-Trent | United Kingdom | Recruiting |
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