NCT02503228

Clinical Assessment of the Missouri Osteochondral Allograft Preservation System: Lifelong Registry

ENROLLING BY INVITATION Last updated 12 July 2025

What this trial tests

trial testing Standard of care osteochondral and or meniscal allograft transplantation in Symptomatic Osteochondral Defect(s) in 5,000 participants. Enrolling by invitation.

Timeline

1 June 2015

Primary endpoint
1 December 2050

1 December 2050

Quick facts

Lead sponsor	University of Missouri-Columbia
Status	ENROLLING BY INVITATION
Study type	OBSERVATIONAL
Enrollment	5,000
Start date	1 June 2015
Primary completion	1 December 2050
Estimated completion	1 December 2050
Sites	1 location across United States

Drugs / interventions tested

• Standard of care osteochondral and or meniscal allograft transplantation

Conditions studied

• Symptomatic Osteochondral Defect(s) — all drugs for Symptomatic Osteochondral Defect(s) →
• Cartilage, Meniscus, Ankle, Knee, Shoulder, Hip — all drugs for Cartilage, Meniscus, Ankle, Knee, Shoulder, Hip →

Sponsor

University of Missouri-Columbia

Who can join

13 and older, any sex, with Symptomatic Osteochondral Defect(s) or Cartilage, Meniscus, Ankle, Knee, Shoulder, Hip. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• International Knee Documentation Committee (IKDC)
  Time frame: annually up to 29 years
  The International Knee Documentation Committee (IKDC) Subjective Knee Form is a patient-oriented questionnaire that assesses symptoms and function in daily living activities.
• PROMIS survey (PROMIS Bank v1.2 - Physical Function)
  Time frame: annually up to 29 years
  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.
• Visual Analogue Scale (VAS) Pain Score
  Time frame: annually up to 29 years
  The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 cm horizontal line, and this rating is then measured from the left edge (=VAS score)
• Single Assessment Numeric Evaluation (SANE)
  Time frame: annually up to 29 years
  SANE is a patient rating from 0-100. Patients rate their current illness score in relation to their pre-injury baseline.
• Success, Revision, Failure
  Time frame: annually up to 29 years
  Revision is defined as a second operation to revise the osteochondral and/or meniscal allograft in at least 1 part of the patient's joint, and failure is defined as conversion to artificial arthroplasty, arthrodesis, or amputation. Successful outcomes are defined as patients reporting return to functional activities with no revision or failure at last recorded follow-up.
• PROMIS survey (PROMIS Bank v1.2 - Physical Function - Mobility
  Time frame: annually up to 29 years
  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.

Sponsor's own description

With institutional review board approval and informed consent, patients are prospectively enrolled into a registry to follow outcomes after osteochondral allograft (OCA) and/or meniscal allograft transplantation. Patients are included when 1 year followup data are available, including complications and reoperations, patient reported outcome measures (PROMs), compliance with rehabilitation, revisions, and failures.

In addition, MOPS grafts are compared to standard preservation grafts, and unipolar, multisurface, and bipolar cohorts, as well as patient compliance variables, are compared.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Serial ultrasonographic imaging can predict failure after meniscus allograft transplantation.
   Cook JL, Cook CR, Rucinski K, Stannard JP. · · 2023 · cited 6× · PMID 37144223 · DOI 10.1177/1742271x221131283