Clinical Registry Assessment of the Missouri Osteochondral Allograft Preservation System - MOPS

Launched by UNIVERSITY OF MISSOURI-COLUMBIA · Jul 16, 2015

Keywords

ClinConnect Summary

This study is a long-term registry that follows people who have had osteochondral allograft (bone and cartilage) and/or meniscal allograft transplantation in the knee (and sometimes hip, ankle, or shoulder). It compares the newer Missouri Osteochondral Preservation System (MOPS) grafts with standard preservation grafts, and also looks at different graft types (unipolar, multisurface, bipolar). It’s an observational, prospective study carried out at the University of Missouri, aiming to enroll up to about 5,000 people and track them for many years to see how well the transplant grafts work over time. Researchers collect patient-reported outcomes, medical imaging, and safety information to understand what helps people do well after surgery.

Who can participate, and what to expect: people 13 years and older with a knee, hip, ankle, or shoulder cartilage defect that is at least 15 millimeters in size, who are willing to follow follow-up visits and complete questionnaires in English. Participants undergo the planned transplant surgery and then have follow-up visits at 6 weeks, 3 months, 6 months, and every year for up to 29 years. Tests may include standard imaging and, at specific times, non-standard MRI scans, blood and urine tests to study healing and inflammation, and careful tracking of whether the grafts stay successful, need revision surgery, or fail (for example, require a total joint replacement). The goal is to learn which methods and patient factors lead to the best long-term results.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults and children age ≥13 years
• • 2. Knee, hip, ankle, or shoulder osteochondral defect ≥15mm as determined by MRI or diagnostic knee arthroscopy for allograft transplantation
• • 3. Must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations.
• • 4. Must be able to read and understand English or a language for which translated versions of the patient reported questionnaires and Informed consent form are available.
• • 5. Must be able to sign informed consent and must voluntarily sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved subject Informed Consent Form.
• Exclusion Criteria:
• • 1. Is a prisoner
• • 2. Is receiving workman's compensation
• • 3. Subject is mentally incompetent such that would preclude the subject from providing adequate consent and/or complying with study requirements