Clinical trial NCT02503228: Clinical Registry Assessment of the Missouri Osteochondral Allograft Preservation System - MOPS
Official title: Clinical Assessment of the Missouri Osteochondral Allograft Preservation System: Lifelong Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Symptomatic Osteochondral Defect(s)
Cartilage, Meniscus, Ankle, Knee, Shoulder, Hip
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 5000
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled will be those that have undergone an OCA and or meniscal transplantation at University of Missouri Healthcare (Mizzou BioJoint Center) and consented to inclusion in the registry

Brief 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.

Detailed description: With institutional review board approval and documented informed consent, patients are prospectively enrolled into a dedicated registry designed to follow outcomes after OCA transplantation with or without meniscal allograft transplantation. All grafts are obtained from tissue banks accredited by the American Association of Tissue Banks (AATB) and used in conformance of the tissue to the US Food and Drug Administration classification of a human cell and tissue product under section 361 of the Public Health Services Act. Initially, standard preservation (SP) grafts stored in refrigeration in proprietary solutions for 21 days after recovery from 1 of 3 AATB accredited tissue banks were used. As a separate arm, first clinical use of Missouri Osteochondral Preservation System (MOPS) grafts, which are stored at room temperature using MOPS methods for up to 56 days after recovery from 1 AATB accredited tissue bank, was assessed. In phase 2, after MOPS grafts became commercially available, type of graft implanted was based on patient-matched graft availability. Then, on the basis of emerging evidence published in the peer-reviewed medical literature, we implemented a shift in practice to discontinue use of SP grafts at our center.

Surgery is performed on patients with at least one large focal full-thickness articular cartilage defect and/or functional deficiency of 1 or both menisci for knee patients, and for hip, ankle or shoulder patients with at least 1 large focal full-thickness defect who chose this treatment option over other nonsurgical or surgical options as indicated and were approved for coverage by their insurance provider. OCA transplantation surgery is performed using press-fit cylindrical grafts and/or custom-cut patient-specific tab-in-slot shell grafts stabilized with either screws, bioabsorbable pins, or bioabsorbable nails. OCA bone is saturated with autogenous bone marrow aspirate concentrate (Angel System; Arthrex, Inc) immediately before implantation after subchondral drill holes are created and the donor bone is thoroughly lavaged to remove marrow elements. Meniscal allograft transplants (fresh or fresh frozen) are performed via a bone plug technique with suspensory fixation or included as part of the tibial OCA transplant. Viable chondrocyte density of OCAs at the time of transplantation are determined when tissues are available, as previously described. Procedure-specific postoperative management protocols are prescribed to each patient undergoing allograft transplantation. All patients receive oral and written instructions regarding postoperative rehabilitation.

Data are collected preoperatively and at 6 weeks, 3 months, 6 months, and yearly after surgery for each case. Demographic and operative data are collected from the electronic medical record. Patient-reported outcome measures (PROMs) are collected at each time point. All reported complications and reoperations are recorded in the electronic medical record. 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 total or partial artificial joint arthroplasty, joint fusion, or amputation. The decision to pursue revision or failure surgery is based on the attending surgeon's discussion of joint pathology, treatment options, and related prognosis in conjunction with patient preference. Successful outcomes are defined as patients reporting return to functional activities with no need for revision or conversion surgery at last recorded follow-up. Descriptive statistics are calculated to report means, ranges, and percentages. On the basis of the difference in graft preservation methodology, cases are also analyzed by cohort as defined by SP versus MOPS. On the basis of surgery type, cases are also analyzed by cohort as defined by unipolar, multisurface, or bipolar transplants. Chi-square or Fisher exact tests are used to assess for significant differences in proportions. When significant differences in proportions are noted, odds ratios are calculated for relevant comparisons. One-way analysis of variance or t tests are used to assess for significant differences among cohorts at respective time points. Repeated measures analyses of variance are used to assess for significant differences within cohorts over time. Kaplan-Meier survival probability estimates with 95% CIs are calculated and compared. Significance is set at P\<.05.

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

Primary outcomes:
measure: International Knee Documentation Committee (IKDC)
timeFrame: annually up to 29 years
measure: PROMIS survey (PROMIS Bank v1.2 - Physical Function)
timeFrame: annually up to 29 years
measure: Visual Analogue Scale (VAS) Pain Score
timeFrame: annually up to 29 years
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: annually up to 29 years
measure: Success, Revision, Failure
timeFrame: annually up to 29 years
measure: PROMIS survey (PROMIS Bank v1.2 - Physical Function - Mobility
timeFrame: annually up to 29 years
Secondary outcomes:
measure: PROMIS survey (PROMIS Bank v1.1 - Pain Interference)
timeFrame: annually up to 29 years
measure: Standard of Care (SOC) Diagnostic Imaging
timeFrame: Pre-operative, 6 week, 3 month, 6 month, and annually up to 29 years
measure: Blood and Urine Samples
timeFrame: Pre-operative, Day of Surgery, 6 week, 3 month, 6 month, and annually up to 29 years
measure: Non-SOC MRI
timeFrame: 12 month visit
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
References:
citation: Schreiner AJ, Stannard JP, Stoker AM, Bozynski CC, Kuroki K, Cook CR, Cook JL. Unicompartmental bipolar osteochondral and meniscal allograft transplantation is effective for treatment of medial compartment gonarthrosis in a canine model. J Orthop Res. 2021 May;39(5):1093-1102. doi: 10.1002/jor.24801. Epub 2020 Jul 27.
citation: Thomas DM, Stannard JP, Pfeiffer FM, Cook JL. Biomechanical Properties of Bioabsorbable Fixation for Osteochondral Shell Allografts. J Knee Surg. 2020 Apr;33(4):365-371. doi: 10.1055/s-0039-1677837. Epub 2019 Feb 6.
citation: Cook JL. Editorial Commentary: Bone Marrow Aspirate Biologics for Osteochondral Allografts-Because We Can or Because We Should? Arthroscopy. 2019 Aug;35(8):2445-2447. doi: 10.1016/j.arthro.2019.04.018.
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citation: Stoker AM, Stannard JP, Cook JL. Chondrocyte Viability at Time of Transplantation for Osteochondral Allografts Preserved by the Missouri Osteochondral Preservation System versus Standard Tissue Bank Protocol. J Knee Surg. 2018 Sep;31(8):772-780. doi: 10.1055/s-0037-1608947. Epub 2017 Dec 11.
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