Clinical trial NCT05655156: OrthoPureXT Multiligament PMCF Study
Official title: Post Market Clinical Follow-Up of OrthoPureXT for the Treatment of Multiligament Injured Knee: a Case Series
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiligament Knee Injuries
Keywords: MLKI
PMCF
ACL PCL MCL LCL
IKDC
KOOS
Lysholm
Xenograft
MLKIs
Knee reconstruction
Knee injuries
Lead sponsor: Tissue Regenix Ltd
Sponsor class: INDUSTRY
First posted: 2022-12-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects with multiligament knee injuries will be evenly distributed across potential ligament reconstruction treatment options: PCL, ACL, MCL, LCL.
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: 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 outcomes:
measure: A change from Baseline in IKDC
timeFrame: 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)
Secondary outcomes:
measure: A change from Baseline in Lysholm
timeFrame: 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)
measure: A change from Baseline in KOOS
timeFrame: 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)
measure: A change from Baseline in Assessment of Laxity via Physical Examination
timeFrame: 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)
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
Study officials:
References: