Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT05655156
Status:
RECRUITING
Last Update Posted:
2025-04-15
First Post:
2022-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OrthoPureXT Multiligament PMCF Study
Sponsor:
Tissue Regenix Ltd
Organization:
Study Overview
Official Title:
Post Market Clinical Follow-Up of OrthoPureXT for the Treatment of Multiligament Injured Knee: a Case Series
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
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:
* Posterior cruciate ligament (PCL)
* Anterior cruciate ligament (ACL)
* Posteromedial corner including the medial collateral ligament (MCL)
* Posterolateral corner including the lateral collateral ligament (LCL)
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:
* Posterior cruciate ligament (PCL)
* Anterior cruciate ligament (ACL)
* Posteromedial corner including the medial collateral ligament (MCL)
* Posterolateral corner including the lateral collateral ligament (LCL)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: