OrthoPureXT Multiligament PMCF Study

Tissue Regenix

Status: Enrolling

Conditions: Multiligament Knee Injuries

Treatments: Device: OrthoPure XT

Study type: Interventional

Funder types: Industry

Identifiers

NCT05655156

A03/0028/P01

Details and patient eligibility

About

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.

Full 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)

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Multiple Knee Ligament Injuries

Experimental group

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)

Treatment:

Device: OrthoPure XT