search
Back to results

OrthoPureXT Multiligament PMCF Study

Primary Purpose

Multiligament Knee Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OrthoPure XT
Sponsored by
Tissue Regenix Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiligament Knee Injuries focused on measuring MLKI, PMCF, ACL PCL MCL LCL, IKDC, KOOS, Lysholm, Xenograft, MLKIs, Knee reconstruction, Knee injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Multiple Knee Ligament Injuries

    Arm Description

    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)

    Outcomes

    Primary Outcome Measures

    A change from Baseline in IKDC
    Assessment of knee stability via evaluation of IKDC score.

    Secondary Outcome Measures

    A change from Baseline in Lysholm
    Assessment of knee stability via evaluation of Lysholm score.
    A change from Baseline in KOOS
    Assessment of knee stability via evaluation of KOOS.
    A change from Baseline in Assessment of Laxity via Physical Examination
    Physical assessment of passive movement focusing on the reconstructed ligament.

    Full Information

    First Posted
    November 16, 2022
    Last Updated
    June 15, 2023
    Sponsor
    Tissue Regenix Ltd
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05655156
    Brief Title
    OrthoPureXT Multiligament PMCF Study
    Official Title
    Post Market Clinical Follow-Up of OrthoPureXT for the Treatment of Multiligament Injured Knee: a Case Series
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    May 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tissue Regenix Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiligament Knee Injuries
    Keywords
    MLKI, PMCF, ACL PCL MCL LCL, IKDC, KOOS, Lysholm, Xenograft, MLKIs, Knee reconstruction, Knee injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Subjects with multiligament knee injuries will be evenly distributed across potential ligament reconstruction treatment options: PCL, ACL, MCL, LCL.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Multiple Knee Ligament Injuries
    Arm Type
    Experimental
    Arm Description
    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)
    Intervention Type
    Device
    Intervention Name(s)
    OrthoPure XT
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    A change from Baseline in IKDC
    Description
    Assessment of knee stability via evaluation of IKDC score.
    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)
    Secondary Outcome Measure Information:
    Title
    A change from Baseline in Lysholm
    Description
    Assessment of knee stability via evaluation of Lysholm score.
    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)
    Title
    A change from Baseline in KOOS
    Description
    Assessment of knee stability via evaluation of 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)
    Title
    A change from Baseline in Assessment of Laxity via Physical Examination
    Description
    Physical assessment of passive movement focusing on the reconstructed ligament.
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anna Kaniewska
    Phone
    +44 (0)3304303052
    Email
    a.kaniewska@tissueregenix.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    OrthoPureXT Multiligament PMCF Study

    We'll reach out to this number within 24 hrs