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RECRUITING
NCT05655156
NA

OrthoPureXT Multiligament PMCF Study

Sponsor: Tissue Regenix Ltd

View on ClinicalTrials.gov

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.

Official title: Post Market Clinical Follow-Up of OrthoPureXT for the Treatment of Multiligament Injured Knee: a Case Series

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2025-04

Completion Date

2026-12

Last Updated

2025-04-15

Healthy Volunteers

No

Interventions

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)

Locations (1)

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom