OrthoPureXT Multiligament PMCF Study

April 14, 2025 updated by: Tissue Regenix Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Recruiting
        • Royal Stoke University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

    1 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
    • Patients with known allergy, hypersensitivity, or religious objection to, implanted porcine material
    • Patients unable or unwilling to follow the post-operative care and rehabilitation programme

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multiple Knee Ligament Injuries

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A change from Baseline in IKDC
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
A change from Baseline in Lysholm
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)
Assessment of knee stability via evaluation of Lysholm 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)
A change from Baseline in 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)
Assessment of knee stability via evaluation of 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
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)
Physical assessment of passive movement focusing on the reconstructed ligament.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tissue Regenix Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A03/0028/P01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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