Trials / Recruiting
RecruitingNCT05655156
OrthoPureXT Multiligament PMCF Study
Post Market Clinical Follow-Up of OrthoPureXT for the Treatment of Multiligament Injured Knee: a Case Series
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- Sponsor
- Tissue Regenix Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2025-04-01
- Primary completion
- 2026-05-01
- Completion
- 2026-12-01
- First posted
- 2022-12-19
- Last updated
- 2025-04-15
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05655156. Inclusion in this directory is not an endorsement.