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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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)
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
RECRUITINGA change from Baseline in IKDC
Assessment of knee stability via evaluation of IKDC score.
Time frame: 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 Lysholm
Assessment of knee stability via evaluation of Lysholm score.
Time frame: 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.
Time frame: 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.
Time frame: 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)
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