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Clinical Assessment of the Missouri Osteochondral Allograft Preservation System - MOPS (MTF-MOPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by University of Missouri-Columbia
Sponsor:
Collaborator:
Musculoskeletal Transplant Foundation
Information provided by (Responsible Party):
James Cook, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT02503228
First received: July 13, 2015
Last updated: August 10, 2016
Last verified: August 2016
  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.


Condition Intervention
Femoral Condyle Osteochondral Defect ≥ 15mm
Other: Receiving MOPS-Preserved Cartilage

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Clinical Assessment of the Missouri Osteochondral Allograft Preservation System - MOPS

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • International Knee Documentation Committee (IKDC) [ Time Frame: Change in IKDC score from the Pre-operative visit to the 24 month visit ] [ Designated as safety issue: No ]
    The International Knee Documentation Committee (IKDC) Subjective Knee Form is a patient-oriented questionnaire that assesses symptoms and function in daily living activities.

  • Tegner Activity Scale [ Time Frame: Change in Tegner Activity Scale score from the Pre-operative visit to the 24 month visit ] [ Designated as safety issue: No ]
    Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities.

  • PROMIS survey (PROMIS Bank v1.2 - Physical Function) [ Time Frame: Change in PROMIS survey score from the Pre-operative visit to the 24 month visit ] [ Designated as safety issue: No ]
    PROMIS® stands for Patient Reported Outcomes Measurement Information System, which is a system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being. In this particular case, this survey assesses the patient's physical function.

  • PROMIS survey (Global Short Form v1.1) [ Time Frame: Change in PROMIS survey score from the Pre-operative visit to the 24 month visit ] [ Designated as safety issue: No ]
    PROMIS® stands for Patient Reported Outcomes Measurement Information System, which is a system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being. In this particular case, this survey assesses the patient's overall health.

  • PROMIS survey (PROMIS Bank v1.1 - Pain Interference) [ Time Frame: Change in PROMIS survey score from the Pre-operative visit to the 24 month visit ] [ Designated as safety issue: No ]
    PROMIS® stands for Patient Reported Outcomes Measurement Information System, which is a system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being. In this particular case, this survey assesses how the patient's pain interferes with their general life style.

  • PROMIS survey (PROMIS Bank v1.2 - Physical Function - Mobility) [ Time Frame: Change in PROMIS survey score from the Pre-operative visit to the 24 month visit ] [ Designated as safety issue: No ]
    PROMIS® stands for Patient Reported Outcomes Measurement Information System, which is a system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being. In this particular case, this survey assesses the patient's mobility.


Secondary Outcome Measures:
  • Standard of Care (SOC) Diagnostic Imaging [ Time Frame: Pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month visits ] [ Designated as safety issue: No ]

    When the study patient attends their standard-of-care visits with their primary surgeon, the surgeon may or may not order diagnostic radiological imaging (X-Ray, MRI) depending on their medical judgment.

    If such radiological imaging is ordered and the images are available, they will be evaluated to assess the healing and integration of the graft.


  • Non-SOC MRI [ Time Frame: 12 month visit ] [ Designated as safety issue: No ]
    A non-standard-of-care MRI will be taken at the 12 month visit to assess the healing and integration of the graft.

  • Blood and Urine Samples [ Time Frame: Pre-operative, Day of Surgery, 6 week, 3 month, 6 month, 12 month, 24 month visits ] [ Designated as safety issue: No ]
    Blood and urine samples will be collected pre-operatively, at each surgical procedure (at the initial surgical procedure and any necessary procedure thereafter), and at each post-operative visit after the initial 2 week visit (6 weeks, 3 months, 6 months, 12 months, 24 months). These samples will be used to evaluate biomarkers associated with tissue inflammation, synthesis, degradation, and cell death.


Estimated Enrollment: 60
Study Start Date: June 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Receiving MOPS-Preserved Cartilage

The group will be receiving a cartilage transplant as standard of care. The only difference between the patients participating in this study and non-study participants will be that the cartilage transplant that study participants receive will be preserved in the MOPS instead of the standard media.

The preservation process will be performed by the Musculoskeletal Transplant Foundation. Once the cartilage is received by the Missouri Orthopaedic Institute, it and the study participant will be treated as though they are preserved in the standard media and a non-study participant, respectively.

Other: Receiving MOPS-Preserved Cartilage
The Missouri Osteochondral Allograft Preservation System (MOPS) preserves donated cartilage tissue that is meant to be transplanted from the time it is obtained from the donor to the time it is transplanted into the recipient. The MOPS is a different media formulation from the standard media that is usually used to preserve the cartilage tissue.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02503228

Contacts
Contact: Stacee Clawson, RN (573) 884-9017 clawsons@health.missouri.edu
Contact: James L Cook, DVM, PhD (573) 884-4689 cookjl@health.missouri.edu

Locations
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Principal Investigator: James L Cook, DVM, PhD         
Sponsors and Collaborators
University of Missouri-Columbia
Musculoskeletal Transplant Foundation
  More Information

Responsible Party: James Cook, William & Kathryn Allen Distinguished Professor in Orthopaedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02503228     History of Changes
Other Study ID Numbers: 2002628 
Study First Received: July 13, 2015
Last Updated: August 10, 2016
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 24, 2016