Symptomatic Osteochondral Defect(s)NCT02503228
Clinical Registry Assessment of the Missouri Osteochondral Allograft Preservation System - MOPS
An observational study of Symptomatic Osteochondral Defect(s) and Cartilage, Meniscus, Ankle, Knee, Shoulder, Hip, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Symptomatic Osteochondral Defect(s), Cartilage, Meniscus, Ankle, Knee, Shoulder, Hip
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Dec 2050
- How long will I take part?
- 100 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Assessment of the Missouri Osteochondral Allograft Preservation System: Lifelong Registry
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.
Read the 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.
- Being tested
- Standard of care osteochondral and or meniscal allograft transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care osteochondral and or meniscal allograft transplantationProcedure or surgery
Standard of care osteochondral and or meniscal allograft transplantation
| Study group | Role | What they receive |
|---|---|---|
| MOPS | Transplanted tissue preserved using the MOPS method and obtained from one AATB-approved tissue bank Receives: Procedure: Standard of care osteochondral and or meniscal allograft transplantation | |
| Standard Preservation | Transplanted tissue preserved using standard preservation methods and obtained from one of three AATB-approved tissue banks Receives: Procedure: Standard of care osteochondral and or meniscal allograft transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee (IKDC)
The International Knee Documentation Committee (IKDC) Subjective Knee Form is a patient-oriented questionnaire that assesses symptoms and function in daily living activities.
Measured: annually up to 29 years
PROMIS survey (PROMIS Bank v1.2 - Physical Function)
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.
Measured: annually up to 29 years
Visual Analogue Scale (VAS) Pain Score
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)
Measured: annually up to 29 years
Single Assessment Numeric Evaluation (SANE)
SANE is a patient rating from 0-100. Patients rate their current illness score in relation to their pre-injury baseline.
Measured: annually up to 29 years
Success, Revision, Failure
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.
Measured: annually up to 29 years
PROMIS survey (PROMIS Bank v1.2 - Physical Function - Mobility
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.
Measured: annually up to 29 years
Secondary outcomes (4)
PROMIS survey (PROMIS Bank v1.1 - Pain Interference)
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.
Measured: annually up to 29 years
Standard of Care (SOC) Diagnostic Imaging
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.
Measured: Pre-operative, 6 week, 3 month, 6 month, and annually up to 29 years
Blood and Urine Samples
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.
Measured: Pre-operative, Day of Surgery, 6 week, 3 month, 6 month, and annually up to 29 years
Non-SOC MRI
A non-standard-of-care MRI will be taken at the 12 month visit to assess the healing and integration of the graft.
Measured: 12 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2050 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Osteochondral Defect(s)Studies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 100 Years
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Cook, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503228
- Sponsor's protocol ID
- 2002628
- Other IDs
- 2003053
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2015
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32672863Thomas 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.
PubMed 30727021Cook 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.
PubMed 31395184Baumann CA, Baumann JR, Bozynski CC, Stoker AM, Stannard JP, Cook JL. Comparison of Techniques for Preimplantation Treatment of Osteochondral Allograft Bone. J Knee Surg. 2019 Jan;32(1):97-104. doi: 10.1055/s-0038-1636834. Epub 2018 Mar 7.
PubMed 29514363Cook JL, Stannard JP, Stoker AM, Bozynski CC, Kuroki K, Cook CR, Pfeiffer FM. Importance of Donor Chondrocyte Viability for Osteochondral Allografts. Am J Sports Med. 2016 May;44(5):1260-8. doi: 10.1177/0363546516629434. Epub 2016 Feb 26.
PubMed 26920431Cook JL, Stoker AM, Stannard JP, Kuroki K, Cook CR, Pfeiffer FM, Bozynski C, Hung CT. A novel system improves preservation of osteochondral allografts. Clin Orthop Relat Res. 2014 Nov;472(11):3404-14. doi: 10.1007/s11999-014-3773-9. Epub 2014 Jul 17.
PubMed 25030100Crist BD, Stoker AM, Pfeiffer FM, Kuroki K, Cook CR, Franklin SP, Stannard JP, Cook JL. Optimising femoral-head osteochondral allograft transplantation in a preclinical model. J Orthop Translat. 2015 Nov 25;5:48-56. doi: 10.1016/j.jot.2015.10.001. eCollection 2016 Apr.
PubMed 30035074Garrity JT, Stoker AM, Sims HJ, Cook JL. Improved osteochondral allograft preservation using serum-free media at body temperature. Am J Sports Med. 2012 Nov;40(11):2542-8. doi: 10.1177/0363546512458575. Epub 2012 Sep 12.
PubMed 22972852Stoker AM, Stannard JP, Kuroki K, Bozynski CC, Pfeiffer FM, Cook JL. Validation of the Missouri Osteochondral Allograft Preservation System for the Maintenance of Osteochondral Allograft Quality During Prolonged Storage. Am J Sports Med. 2018 Jan;46(1):58-65. doi: 10.1177/0363546517727516. Epub 2017 Sep 22.
PubMed 28937783Luk J, Stoker AM, Teixeiro E, Kuroki K, Schreiner AJ, Stannard JP, Wissman R, Cook JL. Systematic Review of Osteochondral Allograft Transplant Immunology: How We Can Further Optimize Outcomes. J Knee Surg. 2021 Jan;34(1):30-38. doi: 10.1055/s-0040-1721670. Epub 2021 Jan 3.
PubMed 33389738Nuelle CW, Nuelle JA, Cook JL, Stannard JP. Patient Factors, Donor Age, and Graft Storage Duration Affect Osteochondral Allograft Outcomes in Knees with or without Comorbidities. J Knee Surg. 2017 Feb;30(2):179-184. doi: 10.1055/s-0036-1584183. Epub 2016 May 26.
PubMed 27228198Stoker AM, Baumann CA, Stannard JP, Cook JL. Bone Marrow Aspirate Concentrate versus Platelet Rich Plasma to Enhance Osseous Integration Potential for Osteochondral Allografts. J Knee Surg. 2018 Apr;31(4):314-320. doi: 10.1055/s-0037-1603800. Epub 2017 Jun 24.
PubMed 28646824Stoker AM, Caldwell KM, Stannard JP, Cook JL. Metabolic responses of osteochondral allografts to re-warming. J Orthop Res. 2019 Jul;37(7):1530-1536. doi: 10.1002/jor.24290. Epub 2019 Mar 28.
PubMed 30912859Rucinski K, Cook JL, Crecelius CR, Stucky R, Stannard JP. Effects of Compliance With Procedure-Specific Postoperative Rehabilitation Protocols on Initial Outcomes After Osteochondral and Meniscal Allograft Transplantation in the Knee. Orthop J Sports Med. 2019 Nov 22;7(11):2325967119884291. doi: 10.1177/2325967119884291. eCollection 2019 Nov.
PubMed 31803790Zitsch BP, Stannard JP, Worley JR, Cook JL, Leary EV. Patient-Reported Outcomes for Large Bipolar Osteochondral Allograft Transplantation in Combination with Realignment Osteotomies for the Knee. J Knee Surg. 2021 Sep;34(11):1260-1266. doi: 10.1055/s-0040-1710361. Epub 2020 May 5.
PubMed 32369842
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of the Missouri Osteochondral Allograft Preservation System: Lifelong Registry
- ClinicalTrials.gov ID
- NCT02503228
- Acronym / sponsor ID
- 2002628
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2050 (estimated)
- Study completion
- Dec 2050 (estimated)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 100 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOPS | – | Procedure: Standard of care osteochondral and or meniscal allograft transplantationTransplanted tissue preserved using the MOPS method and obtained from one AATB-approved tissue bank |
| Standard Preservation | – | Procedure: Standard of care osteochondral and or meniscal allograft transplantationTransplanted tissue preserved using standard preservation methods and obtained from one of three AATB-approved tissue banks |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care osteochondral and or meniscal allograft transplantationStandard of care osteochondral and or meniscal allograft transplantation | Procedure or surgery | MOPS, Standard Preservation |
Primary outcome
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.
4 secondary outcomes
PROMIS survey (PROMIS Bank v1.1 - Pain Interference)
Time frame: annually up to 29 years
Standard of Care (SOC) Diagnostic Imaging
Time frame: Pre-operative, 6 week, 3 month, 6 month, and annually up to 29 years
Blood and Urine Samples
Time frame: Pre-operative, Day of Surgery, 6 week, 3 month, 6 month, and annually up to 29 years
Non-SOC MRI
Time frame: 12 month visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 32672863Schreiner 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.
- Background: PubMed 30727021Thomas 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.
- Background: PubMed 31395184Cook 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.
- Background: PubMed 29514363Baumann CA, Baumann JR, Bozynski CC, Stoker AM, Stannard JP, Cook JL. Comparison of Techniques for Preimplantation Treatment of Osteochondral Allograft Bone. J Knee Surg. 2019 Jan;32(1):97-104. doi: 10.1055/s-0038-1636834. Epub 2018 Mar 7.
- Background: PubMed 26920431Cook JL, Stannard JP, Stoker AM, Bozynski CC, Kuroki K, Cook CR, Pfeiffer FM. Importance of Donor Chondrocyte Viability for Osteochondral Allografts. Am J Sports Med. 2016 May;44(5):1260-8. doi: 10.1177/0363546516629434. Epub 2016 Feb 26.
- Background: PubMed 25030100Cook JL, Stoker AM, Stannard JP, Kuroki K, Cook CR, Pfeiffer FM, Bozynski C, Hung CT. A novel system improves preservation of osteochondral allografts. Clin Orthop Relat Res. 2014 Nov;472(11):3404-14. doi: 10.1007/s11999-014-3773-9. Epub 2014 Jul 17.
- Background: PubMed 30035074Crist BD, Stoker AM, Pfeiffer FM, Kuroki K, Cook CR, Franklin SP, Stannard JP, Cook JL. Optimising femoral-head osteochondral allograft transplantation in a preclinical model. J Orthop Translat. 2015 Nov 25;5:48-56. doi: 10.1016/j.jot.2015.10.001. eCollection 2016 Apr.
- Background: PubMed 22972852Garrity JT, Stoker AM, Sims HJ, Cook JL. Improved osteochondral allograft preservation using serum-free media at body temperature. Am J Sports Med. 2012 Nov;40(11):2542-8. doi: 10.1177/0363546512458575. Epub 2012 Sep 12.
- Background: PubMed 28937783Stoker AM, Stannard JP, Kuroki K, Bozynski CC, Pfeiffer FM, Cook JL. Validation of the Missouri Osteochondral Allograft Preservation System for the Maintenance of Osteochondral Allograft Quality During Prolonged Storage. Am J Sports Med. 2018 Jan;46(1):58-65. doi: 10.1177/0363546517727516. Epub 2017 Sep 22.
- Background: PubMed 33389738Luk J, Stoker AM, Teixeiro E, Kuroki K, Schreiner AJ, Stannard JP, Wissman R, Cook JL. Systematic Review of Osteochondral Allograft Transplant Immunology: How We Can Further Optimize Outcomes. J Knee Surg. 2021 Jan;34(1):30-38. doi: 10.1055/s-0040-1721670. Epub 2021 Jan 3.
- Background: PubMed 27228198Nuelle CW, Nuelle JA, Cook JL, Stannard JP. Patient Factors, Donor Age, and Graft Storage Duration Affect Osteochondral Allograft Outcomes in Knees with or without Comorbidities. J Knee Surg. 2017 Feb;30(2):179-184. doi: 10.1055/s-0036-1584183. Epub 2016 May 26.
- Background: PubMed 28646824Stoker AM, Baumann CA, Stannard JP, Cook JL. Bone Marrow Aspirate Concentrate versus Platelet Rich Plasma to Enhance Osseous Integration Potential for Osteochondral Allografts. J Knee Surg. 2018 Apr;31(4):314-320. doi: 10.1055/s-0037-1603800. Epub 2017 Jun 24.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Symptomatic Osteochondral Defect(s) and Cartilage, Meniscus, Ankle, Knee, Shoulder, Hip, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee (IKDC) (time frame: annually up to 29 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02503228, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.