OrthoPureXT Multiligament PMCF Study

Sponsor

Tissue Regenix Ltd (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05655156

Collaborator

(none)

Enrollment

Arm

36.9

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiligament Knee Injuries	Device: OrthoPure XT	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

A change from Baseline in IKDC [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.

Secondary Outcome Measures

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)]
Assessment of knee stability via evaluation of Lysholm score.
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)]
Assessment of knee stability via evaluation of KOOS.
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)]
Physical assessment of passive movement focusing on the reconstructed ligament.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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