OrthoPure™ XT Pilot Clinical Study

Withdrawn before enrolling · Not applicable

Conditions studied: Knee Injuries, Anterior Cruciate Ligament (ACL) Reconstruction

In brief

To evaluate the clinical safety and obtain preliminary effectiveness data for OrthoPure™ XT device in a small group of US patients at 12 and 24 months. The clinical experience obtained from this study will be used to develop a pivotal study for follow up in a larger patient population.

Key facts

Study ID

NCT03562299

Run by

TRX Orthopedics

People needed

0

Starts

2018-07-01

Expected to finish

2020-12-01

Last updated by the study team

2018-11-21

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are skeletally mature, as evidenced by closed tibial and femoral epiphyses on x-rays at baseline.
• Patients who have been diagnosed with a partial or complete tear of the ACL as determined by MRI, require surgical reconstruction of the ACL, and are candidates for ACL surgery.
• Patients who have passive flexion ≥ 120°, and passive extension on the target knee is the same as the contralateral knee, in the judgment of the Investigator.
• Patients who have Medial Collateral Ligament (MCL) injury of Grade 2 or less.
• Patients with osteoarthritis of Grade 2 or less as defined radiographically on the Kellgren-Lawrence (K-L) scale.
• Patients who are able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study.
• Patients who are willing and able to comply with all study procedures including all pre-operative, post-operative and rehabilitation requirements.
• If female and of child-bearing potential, patients who have a negative urine pregnancy test at Visit 2 and have no intention to become pregnant in the next 24 months.

You may not qualify if…

• Patients with Body Mass Index (BMI) greater than 35 kg/m2.
• Patients presenting with osteoarthritis of the target knee e.g. International Cartilage Repair Society (ICRS) Grade III or higher as determined by their baseline MRI scan.
• Patients who have had previous ACL reconstruction on the target knee.
• Patients who have had any other type of surgical procedure on the target knee in the 3 months prior to Visit 1.
• Patients with ligament instability, osteoarthritis greater than Grade 2 or a current ACL injury in the contralateral knee.
• Patients with a complete or partial Lateral Collateral Ligament (LCL) tear or Posterior Cruciate Ligament (PCL) tear on the target knee.
• Patients with meniscal repairs and tears requiring more than one third (1/3) removal of the meniscus on the target knee as determined during knee arthroscopy.
• Patients who have an active systemic infection, or an active local infection in or near the target knee, or have a previous history of joint infection.
• Patients who are participating concurrently in another clinical trial, or have participated in a clinical trial within the last 90 days, or intend to during the course of the study.
• Patients who have previously been implanted with any type of xenograft device.
• Patients with known immunodeficiency including patients who are receiving or have received corticosteroids, immunosuppressants, immunostimulating agents or radiation therapy within 6 months of Visit 1.
• Patients who have conditions that may be exacerbated by, or may interfere with the results of the skin prick test.
• Patients with significant comorbidities or conditions associated with high risk for surgical or anesthetic survival (e.g. renal failure, peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.).
• Patients with active neoplastic disease.
• Patients with known allergy to mammalian meat, porcine products or a religious objection to the use of implanted porcine material.
• Patients with current drug or alcohol abuse, or a history of the same within the last 6 months.
• Patients with local circulatory problems, (e.g. thrombophlebitis and lymphedema).
• Patients with any mental or psychological disorder that would impair their ability to complete the study questionnaires.
• Patients with any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the patient unable to perform appropriate postoperative rehabilitation.
• Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.

Where it is running

• St.Joseph's Outpatient Surgery Center — Phoenix, Arizona, United States
• OrthoIndy Hospital South — Greenwood, Indiana, United States
• Jewish Hospital — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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