Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
28 participants
INTERVENTIONAL
2025-04-30
2026-12-31
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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)
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Tissue Regenix Ltd
INDUSTRY
Responsible Party
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Locations
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Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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A03/0028/P01
Identifier Type: -
Identifier Source: org_study_id
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