OrthoPureXT Multiligament PMCF Study

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Multiligament Knee Injuries

Intervention / Treatment
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* Device: OrthoPure XT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiple Knee Ligament Injuries<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change from Baseline in Lysholm | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MLKI, PMCF, ACL PCL MCL LCL, IKDC, KOOS, Lysholm, Xenograft, MLKIs, Knee reconstruction, Knee injuries