Columbia, Missouri 65212


Purpose:

Patients who have a large enough defect in their knee cartilage will sometimes undergo surgery to transplant donor cartilage tissue into their defect in an attempt to repair the knee. The donor cartilage tissue must be fully tested for disease and contamination before it can be placed into a patient. This time, along with the time needed to coordinate the surgery and transport the tissue to the hospital, can be substantial. Cartilage tissue does not last for long outside a body and the fresher the tissue is, the more likely it is that the patient receiving the transplant will heal better. The MOPS was developed to preserve the cartilage tissue better than the currently standard preservation system is able to. Patients that are enrolled into this study will receive cartilage tissue that has been stored in the MOPS instead of the currently standard preservation system. Their surgical procedure will not change and be performed as per usual. The patient will then be followed for a period of two years in which their progress will be assessed using surveys and the healing and integration of the transplanted tissue will be assessed using diagnostic imaging and blood and urine samples.


Study summary:

Patients that are enrolled in this study will receive an osteochondral allograft from tissue that has been stored in the MOPS instead of the currently standard preservation system (culture media at 4 degrees Celsius). This will be the only difference in the surgical procedure between enrolled patients and non-study patients. Enrolled patients will undergo their grafting procedure as they normally would if they were not enrolled in this study. They will also receive the same care as non-study patients. Enrolled patients will, however, be asked to fill out surveys about their health, activity level, level of pain, and general quality of life (IKDC, Tegner, PROMIS surveys) at a pre-operative visit and at post-operative visits at 3 months, 6 months, 12 months, and 24 months after surgery. They will also be asked to provide blood and urine samples at a pre-operative visit, the day of surgery, and at post-operative visits at 6 weeks, 3 months, 6 months, 12 months, and 24 month after their surgery. Also, there will be a non-standard of care MRI taken at 12 months after surgery. Finally, any diagnostic imaging that is done as part of the standard of care will also be reviewed by the investigators. No additional diagnostic imaging will take place outside of the non-standard of care MRI at 12 months after surgery; this imaging review will simply be taking advantage of diagnostic imaging that would be available even for a non-study patient. The surveys assess the progress of patient function and general well-being. The blood and urine samples, as well as the MRI will assess the healing and integration of the osteochondral allograft.


Criteria:

Inclusion Criteria: 1. Adults age ≥18 years 2. Femoral condyle 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 and willing to follow a standardized rehabilitation protocol. 5. 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. 6. 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. 7. Must be able and willing to undergo MRI's. Exclusion Criteria: 1. Presence of ipsilateral articular fractures or extensor mechanism injuries or need for concurrent meniscal transplantation 2. Presence of severe soft tissue injuries around the knee that have required or may require skin grafting or flap coverage. 3. Presence of a previous below knee amputation 4. Presence of inflammatory systemic arthritis or disease involving the index joint (i.e. gout) 5. Is a prisoner 6. Is receiving workman's compensation 7. Subject is mentally incompetent such that would preclude the subject from providing adequate consent and/or complying with study requirements 8. Based on a clinical history, physical examination and/or subject presentation, subject has, or is suspected to have, a history of alcohol and/or drug abuse that would preclude subject from providing adequate consent and/or complying with study requirements 9. Pregnant females


NCT ID:

NCT02503228


Primary Contact:

Stacee Clawson, RN
Phone: (573) 884-9017
Email: clawsons@health.missouri.edu


Backup Contact:

Email: cookjl@health.missouri.edu
James L Cook, DVM, PhD
Phone: (573) 884-4689


Location Contact:

Columbia, Missouri 65212
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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