An interventional study of OrthoPure XT in Multiligament Knee Injuries, sponsored by Tissue Regenix Ltd. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by Tissue Regenix Ltd · Not applicable, Interventional, and Treatment
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.
OrthoPureXT is an acellular, sterile, single use, xenograft (porcine) tissue scaffold that is manufactured using a proprietary decellularisation technology that renders the tissue substantially free from cells, leaving the porcine tissue biocompatible, and safe for implantation into the knee.
28 patients in total to be evenly distributed across potential ligament reconstruction treatment options (n=7 per sub-group) and resulting in a statistically relevant number per sub-group considering potential loss to follow up.
Sub-groups of n=7 incurring ligament reconstruction using OrthoPure XT in the following anatomical locations:
249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.
This study's planned enrollment of 28 is below the median of 50 across 160 interventional studies indexed under Knee Injuries.
Browse Knee Injuries studies →Tissue Regenix Ltd is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Those considered as conflicting variables by the investigator. This may include, but is not limited to:
Those considered as physical barriers by the investigator, preventing physical or ethical collection of study data. This may include, but is not limited to:
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.:
Sub-groups of n=7 incurring ligament reconstruction using OrthoPureXT in the following anatomical locations: * Posterior cruciate ligament (PCL) * Anterior cruciate ligament (ACL) * Posteromedial corner including the medial collateral ligament (MCL) * Posterolateral corner including the lateral collateral ligament (LCL)
Device: 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)
A change from Baseline in IKDC
Assessment of knee stability via evaluation of IKDC score.
Time frame: 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)
A change from Baseline in Lysholm
Assessment of knee stability via evaluation of Lysholm score.
Time frame: 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)
A change from Baseline in KOOS
Assessment of knee stability via evaluation of KOOS.
Time frame: 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)
A change from Baseline in Assessment of Laxity via Physical Examination
Physical assessment of passive movement focusing on the reconstructed ligament.
Time frame: 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)
Plan to share: No
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Tissue Regenix Ltd