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)
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Royal Stoke University Hospital
Stoke-on-Trent
United Kingdom
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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