By InvitationNot Applicable

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

United States5,000 participantsStarted 2015-06

Plain-language summary

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.

Who can participate

Age range13 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults and children age ≥13 years
✓. Knee, hip, ankle, or shoulder osteochondral defect ≥15mm as determined by MRI or diagnostic knee arthroscopy for allograft transplantation
✓. Must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations.
✓. 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.
✓. 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

✕. Is a prisoner
✕. Is receiving workman's compensation
✕. Subject is mentally incompetent such that would preclude the subject from providing adequate consent and/or complying with study requirements

What they're measuring

International Knee Documentation Committee (IKDC)

Timeframe: annually up to 29 years

PROMIS survey (PROMIS Bank v1.2 - Physical Function)

Timeframe: annually up to 29 years

Visual Analogue Scale (VAS) Pain Score

Timeframe: annually up to 29 years

Single Assessment Numeric Evaluation (SANE)

Timeframe: annually up to 29 years

Success, Revision, Failure

Timeframe: annually up to 29 years

PROMIS survey (PROMIS Bank v1.2 - Physical Function - Mobility

Timeframe: annually up to 29 years

Trial details

NCT IDNCT02503228

SponsorUniversity of Missouri-Columbia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2050-12

View on ClinicalTrials.gov More Symptomatic Osteochondral Defect(s) trials

Plain-language summary

Who can participate

Age range13 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults and children age ≥13 years
✓. Knee, hip, ankle, or shoulder osteochondral defect ≥15mm as determined by MRI or diagnostic knee arthroscopy for allograft transplantation
✓. Must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations.
✓. 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.
✓. 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

✕. Is a prisoner
✕. Is receiving workman's compensation
✕. Subject is mentally incompetent such that would preclude the subject from providing adequate consent and/or complying with study requirements

What they're measuring

International Knee Documentation Committee (IKDC)

Timeframe: annually up to 29 years

PROMIS survey (PROMIS Bank v1.2 - Physical Function)

Timeframe: annually up to 29 years

Visual Analogue Scale (VAS) Pain Score

Timeframe: annually up to 29 years

Single Assessment Numeric Evaluation (SANE)

Timeframe: annually up to 29 years

Success, Revision, Failure

Timeframe: annually up to 29 years

PROMIS survey (PROMIS Bank v1.2 - Physical Function - Mobility

Timeframe: annually up to 29 years