OrthoPureXT Multiligament PMCF Study

NCT05655156 | Recruiting

• 1 other identifier: A03/0028/P01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiligament Knee Injuries

Keywords

MLKI; PMCF; ACL PCL MCL LCL; IKDC; KOOS; Lysholm; Xenograft; MLKIs; Knee reconstruction; Knee injuries

Outcome Measures

Primary Outcomes (1)

• A change from Baseline in IKDC

  Assessment of knee stability via evaluation of IKDC score.

  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)

Secondary Outcomes (3)

• A change from Baseline in Lysholm

  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

  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

  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)

Study Arms (1)

Multiple Knee Ligament Injuries

EXPERIMENTAL

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

Interventions

OrthoPure XT DEVICE

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)

Multiple Knee Ligament Injuries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged 18 years old or above.
• Adults suffering with multiple knee ligament injuries.
• Ability to communicate meaningfully with investigative staff, competence to give written informed consent; and willingness and ability to comply with entire study procedures including rehabilitation protocol.

You may not qualify if:

• Those unable to give consent.
• Those considered as conflicting variables by the investigator. This may include, but is not limited to:
• Open trauma
• Neurovascular emergencies
• Compartment syndrome
• Life threatening injury
• Those considered as physical barriers by the investigator, preventing physical or ethical collection of study data. This may include, but is not limited to:
• Associated fractures that require external fixators
• Local severe concomitant injuries
• Injuries to other parts of the body associated with a high level of daily activity/intervention for the patient
• Those considered as a poor candidate for surgery by the investigator.
• If female and of child-bearing potential must not have a positive pregnancy test at Visit
• nor have a stated intention to become pregnant in the next 12 months.
• Those patients contraindicated for in the IFU, i.e.:
• Showing signs of infection within 24 hours prior to surgery

Sponsors & Collaborators

• Tissue Regenix Ltd: lead

Study Sites (1)

Royal Stoke University Hospital

Stoke-on-Trent, ST4 6QG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Central Study Contacts

Anna Kaniewska

CONTACT

+44 (0)3304303052; a.kaniewska@tissueregenix.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects with multiligament knee injuries will be evenly distributed across potential ligament reconstruction treatment options: PCL, ACL, MCL, LCL.

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 19, 2022
• Study Start: April 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)