Osteochondral DefectNCT07909928
Biologic Augmentation of Osteochondral Allograft Transplantation in the Knee
A study testing Biologically Augmented Osteochondral Allograft Transplantation in people with Osteochondral Defect and Articular Cartilage Defect, run by University of Minnesota at 1 site in United States.
Trial summary
This prospective, single-center pilot study will evaluate biologic augmentation during osteochondral allograft transplantation of the knee using a combination of bone marrow aspirate concentrate (BMAC) and Arthrex AlloSync Pure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteochondral Defect, Articular Cartilage Defect
- What is being tested?
- Biologically Augmented Osteochondral Allograft Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2026to 20 Jul 2028
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years of age or older.
- Scheduled to undergo osteochondral allograft transplantation of the knee with Dr. Jeffrey Macalena or Dr. Bradley Nelson.
- Medial or lateral femoral condyle osteochondral lesion deemed appropriate for treatment with osteochondral allograft transplantation.
- Able to understand and provide informed consent.
- Willing and able to comply with all study procedures and follow-up requirements.
Who cannot join
- Younger than 18 years of age.
- Unable to provide informed consent, including individuals with absent, diminished, or fluctuating decision-making capacity.
- Unwilling or unable to comply with study procedures or follow-up requirements.
- Medical, psychiatric, or social condition that, in the opinion of the investigator, would interfere with study participation or interpretation of study results.
- Participation in another research study that could affect study outcomes, at the discretion of the investigator.
- Non-English-speaking individuals.
- Prisoners.
- Employees or students of the researcher.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
M Health Fairview Clinics and Surgery Center, 909 Fulton Street SE
Minneapolis, Minnesota, 55455
Anne Paulison, 612-625-3526, pauli098@umn.edu
About this study
Official title: Biologic Augmentation for Osteochondral Allograft Transplantation: A Prospective Case-Series
This prospective, single-center pilot study will evaluate biologic augmentation during osteochondral allograft transplantation of the knee using a combination of bone marrow aspirate concentrate (BMAC) and Arthrex AlloSync Pure.
Approximately 10 adults undergoing osteochondral allograft transplantation for focal osteochondral defects of the medial or lateral femoral condyle will be enrolled. During surgery, BMAC will be collected from the tibial tubercle and mixed with Arthrex AlloSync Pure. The mixture will be applied to the recipient socket and graft plug before allograft implantation.
The primary objective is to assess osteochondral allograft incorporation using magnetic resonance imaging (MRI) at 6 months after surgery. Secondary outcomes include MRI-based graft incorporation at 12 weeks and, when clinically indicated, 12 months; knee function and pain measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Visual Analog Scale (VAS); radiographic graft healing; and postoperative complications and adverse events during one year of follow-up.
Read the detailed description
Osteochondral allograft (OCA) transplantation is an established treatment for large focal cartilage and osteochondral defects of the knee. Successful clinical outcomes depend on graft viability, osseous integration, and restoration of the articular surface. Biologic augmentation using bone marrow aspirate concentrate (BMAC) has been investigated as a strategy to improve graft incorporation, but available clinical evidence remains limited and inconsistent.
This prospective, single-center pilot case series will evaluate graft incorporation and clinical outcomes following osteochondral allograft transplantation augmented with a combination of Arthrex AlloSync Pure and BMAC.
Approximately 10 adult patients scheduled for OCA transplantation of the medial or lateral femoral condyle with Dr. Jeffrey Macalena or Dr. Bradley Nelson will be recruited at the University of Minnesota and M Health Fairview Clinics and Surgery Center.
During the planned surgical procedure, bone marrow will be aspirated from the tibial tubercle and processed to obtain BMAC. The BMAC will be mixed with Arthrex AlloSync Pure to create a biologic slurry. This mixture will be applied to the base of the recipient socket and along the walls of the graft plug before implantation of the osteochondral allograft.
Participants will be followed for approximately one year after surgery. Follow-up assessments will occur at approximately 1 week, 6 weeks, 12 weeks, 6 months, and 1 year. Patient-reported outcome measures will include the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Visual Analog Scale (VAS) for pain.
MRI evaluations will be performed at 12 weeks and 6 months after surgery, with additional MRI at 12 months for participants with incomplete graft incorporation at the 6-month assessment. MRI findings will be evaluated using the Osteochondral Allograft MRI Scoring System (OCAMRISS) and other indicators of graft incorporation. Standard-of-care radiographs will also be reviewed to assess graft healing.
The primary outcome is MRI-based osteochondral allograft incorporation at 6 months after surgery. Secondary outcomes include MRI-based incorporation at other follow-up time points, knee function and pain, radiographic healing, postoperative complications, adverse events, and subsequent procedures related to the index surgery.
Because this is an exploratory pilot study with a small sample size, outcomes will be summarized descriptively. Observed graft incorporation findings may be compared qualitatively with results reported in the published literature. There is no randomized or concurrent control group.
- Conditions
- Osteochondral Defect, Articular Cartilage Defect
- Being tested
- Biologically Augmented Osteochondral Allograft Transplantation
- Keywords
- Osteochondral allograft, OCA transplantation, Cartilage transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologically Augmented Osteochondral Allograft TransplantationProcedure or surgery
Also called OCA Transplantation With BMAC and AlloSync Pure
Participants will undergo osteochondral allograft transplantation of the knee with biologic augmentation. Bone marrow will be aspirated from the tibial tubercle and processed to obtain bone marrow aspirate concentrate (BMAC). BMAC will be mixed with Arthrex AlloSync Pure to create a biologic slurry. This mixture will be applied to the base of the recipient socket and along the walls of the graft plug before implantation of the osteochondral allograft. Participants will receive routine postoperative care and complete scheduled follow-up assessments.
| Study group | Role | What they receive |
|---|---|---|
| Biologically Augmented Osteochondral Allograft Transplantation | Experimental | All participants will undergo osteochondral allograft transplantation of the knee with biologic augmentation using bone marrow aspirate concentrate (BMAC) and Arthrex AlloSync Pure. Bone marrow will be aspirated from the tibial tubercle and processed to obtain BMAC. The BMAC will be combined with AlloSync Pure and applied to the recipient socket and graft plug before allograft implantation. Participants will complete postoperative imaging and clinical outcome assessments over one year. Receives: Procedure: Biologically Augmented Osteochondral Allograft Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteochondral Allograft Incorporation Assessed by MRI
Osteochondral allograft incorporation will be assessed using magnetic resonance imaging (MRI) at 6 months after surgery. MRI findings will be evaluated using the Osteochondral Allograft MRI Scoring System (OCAMRISS) and other radiographic indicators of graft incorporation. Results will be summarized descriptively.
Measured: 6 months after surgery
Secondary outcomes (18)
Osteochondral Allograft Incorporation at 12 Weeks
Osteochondral allograft incorporation will be assessed using MRI at 12 weeks after surgery. MRI findings will be evaluated using OCAMRISS and other radiographic indicators of graft incorporation and summarized descriptively.
Measured: 12 weeks after surgery
Osteochondral Allograft Incorporation at 12 Months
Additional MRI evaluation will be performed at 12 months for participants with incomplete graft incorporation at the 6-month assessment. Graft incorporation will be assessed using OCAMRISS and other MRI indicators of graft healing.
Measured: 12 months after surgery, if clinically indicated
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient-reported knee symptoms and function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and scheduled postoperative follow-up visits. Changes in KOOS scores over time will be summarized descriptively.
Measured: Baseline, 1 week, 6 weeks, 12 weeks, 6 months, and 1 year after surgery
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient-reported knee symptoms and function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and scheduled postoperative follow-up visits. Changes in KOOS scores over time will be summarized descriptively.
Measured: Baseline
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient-reported knee symptoms and function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and scheduled postoperative follow-up visits. Changes in KOOS scores over time will be summarized descriptively.
Measured: 1 week
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient-reported knee symptoms and function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and scheduled postoperative follow-up visits. Changes in KOOS scores over time will be summarized descriptively.
Measured: 6 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient-reported knee symptoms and function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and scheduled postoperative follow-up visits. Changes in KOOS scores over time will be summarized descriptively.
Measured: 12 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient-reported knee symptoms and function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and scheduled postoperative follow-up visits. Changes in KOOS scores over time will be summarized descriptively.
Measured: 6 months
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient-reported knee symptoms and function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and scheduled postoperative follow-up visits. Changes in KOOS scores over time will be summarized descriptively.
Measured: 1 year after surgery
Change in Pain Measured by Visual Analog Scale (VAS)
Patient-reported pain will be assessed using a Visual Analog Scale (VAS) at baseline and scheduled postoperative follow-up visits. Changes in pain ratings over time will be summarized descriptively.
Measured: Baseline
Change in Pain Measured by Visual Analog Scale (VAS)
Patient-reported pain will be assessed using a Visual Analog Scale (VAS) at baseline and scheduled postoperative follow-up visits. Changes in pain ratings over time will be summarized descriptively.
Measured: 1 week
Change in Pain Measured by Visual Analog Scale (VAS)
Patient-reported pain will be assessed using a Visual Analog Scale (VAS) at baseline and scheduled postoperative follow-up visits. Changes in pain ratings over time will be summarized descriptively.
Measured: 6 weeks
Change in Pain Measured by Visual Analog Scale (VAS)
Patient-reported pain will be assessed using a Visual Analog Scale (VAS) at baseline and scheduled postoperative follow-up visits. Changes in pain ratings over time will be summarized descriptively.
Measured: 12 weeks
Change in Pain Measured by Visual Analog Scale (VAS)
Patient-reported pain will be assessed using a Visual Analog Scale (VAS) at baseline and scheduled postoperative follow-up visits. Changes in pain ratings over time will be summarized descriptively.
Measured: 6 months
Change in Pain Measured by Visual Analog Scale (VAS)
Patient-reported pain will be assessed using a Visual Analog Scale (VAS) at baseline and scheduled postoperative follow-up visits. Changes in pain ratings over time will be summarized descriptively.
Measured: 1 year after surgery
Radiographic Evidence of Graft Incorporation and Healing
Radiographic evidence of osteochondral allograft incorporation and healing will be evaluated using standard-of-care postoperative radiographs obtained throughout the follow-up period. Radiographic findings will be summarized descriptively.
Measured: Through 1 year after surgery
Postoperative Complications and Adverse Events
Postoperative complications and adverse events related to osteochondral allograft transplantation and biologic augmentation will be collected through clinical follow-up and review of medical records during the 1-year postoperative period.
Measured: From surgery through 1 year after surgery
Subsequent Procedures Related to Index Surgery
Subsequent surgical or other procedures related to the index osteochondral allograft transplantation will be recorded during the 1-year postoperative follow-up period.
Measured: From surgery through 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start20 Nov 2026 (estimated)
- Primary completion20 Jan 2028 (estimated)
- Study completion20 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral DefectStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-center, single-group pilot study evaluating biologic augmentation during osteochondral allograft transplantation of the knee. Approximately 10 participants will undergo osteochondral allograft transplantation with a combination of bone marrow aspirate concentrate and Arthrex AlloSync Pure applied to the recipient socket and graft plug. Graft incorporation will be evaluated using postoperative MRI, and clinical outcomes will be assessed using patient-reported measures during one year of follow-up. There is no randomization or concurrent control group.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Sponsor
- Investigators
- Jeffrey Macalena, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909928
- Sponsor's protocol ID
- ORTHOSURG-2026-35251
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologic Augmentation for Osteochondral Allograft Transplantation: A Prospective Case-Series
- ClinicalTrials.gov ID
- NCT07909928
- Acronym / sponsor ID
- ORTHOSURG-2026-35251
- Conditions
- Osteochondral Defect, Articular Cartilage Defect
- Keywords
- Osteochondral allograft, OCA transplantation, Cartilage transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 20 Jan 2028 (estimated)
- Study completion
- 20 Jul 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- 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.
This prospective, single-center pilot study will evaluate biologic augmentation during osteochondral allograft transplantation of the knee using a combination of bone marrow aspirate concentrate (BMAC) and Arthrex AlloSync Pure.
Approximately 10 adults undergoing osteochondral allograft transplantation for focal osteochondral defects of the medial or lateral femoral condyle will be enrolled. During surgery, BMAC will be collected from the tibial tubercle and mixed with Arthrex AlloSync Pure. The mixture will be applied to the recipient socket and graft plug before allograft implantation.
The primary objective is to assess osteochondral allograft incorporation using magnetic resonance imaging (MRI) at 6 months after surgery. Secondary outcomes include MRI-based graft incorporation at 12 weeks and, when clinically indicated, 12 months; knee function and pain measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Visual Analog Scale (VAS); radiographic graft healing; and postoperative complications and adverse events during one year of follow-up.
Detailed description
Osteochondral allograft (OCA) transplantation is an established treatment for large focal cartilage and osteochondral defects of the knee. Successful clinical outcomes depend on graft viability, osseous integration, and restoration of the articular surface. Biologic augmentation using bone marrow aspirate concentrate (BMAC) has been investigated as a strategy to improve graft incorporation, but available clinical evidence remains limited and inconsistent.
This prospective, single-center pilot case series will evaluate graft incorporation and clinical outcomes following osteochondral allograft transplantation augmented with a combination of Arthrex AlloSync Pure and BMAC.
Approximately 10 adult patients scheduled for OCA transplantation of the medial or lateral femoral condyle with Dr. Jeffrey Macalena or Dr. Bradley Nelson will be recruited at the University of Minnesota and M Health Fairview Clinics and Surgery Center.
During the planned surgical procedure, bone marrow will be aspirated from the tibial tubercle and processed to obtain BMAC. The BMAC will be mixed with Arthrex AlloSync Pure to create a biologic slurry. This mixture will be applied to the base of the recipient socket and along the walls of the graft plug before implantation of the osteochondral allograft.
Participants will be followed for approximately one year after surgery. Follow-up assessments will occur at approximately 1 week, 6 weeks, 12 weeks, 6 months, and 1 year. Patient-reported outcome measures will include the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Visual Analog Scale (VAS) for pain.
MRI evaluations will be performed at 12 weeks and 6 months after surgery, with additional MRI at 12 months for participants with incomplete graft incorporation at the 6-month assessment. MRI findings will be evaluated using the Osteochondral Allograft MRI Scoring System (OCAMRISS) and other indicators of graft incorporation. Standard-of-care radiographs will also be reviewed to assess graft healing.
The primary outcome is MRI-based osteochondral allograft incorporation at 6 months after surgery. Secondary outcomes include MRI-based incorporation at other follow-up time points, knee function and pain, radiographic healing, postoperative complications, adverse events, and subsequent procedures related to the index surgery.
Because this is an exploratory pilot study with a small sample size, outcomes will be summarized descriptively. Observed graft incorporation findings may be compared qualitatively with results reported in the published literature. There is no randomized or concurrent control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-center, single-group pilot study evaluating biologic augmentation during osteochondral allograft transplantation of the knee. Approximately 10 participants will undergo osteochondral allograft transplantation with a combination of bone marrow aspirate concentrate and Arthrex AlloSync Pure applied to the recipient socket and graft plug. Graft incorporation will be evaluated using postoperative MRI, and clinical outcomes will be assessed using patient-reported measures during one year of follow-up. There is no randomization or concurrent control group.
| Arm | Type | Receives |
|---|---|---|
| Biologically Augmented Osteochondral Allograft Transplantation | Experimental | Procedure: Biologically Augmented Osteochondral Allograft TransplantationAll participants will undergo osteochondral allograft transplantation of the knee with biologic augmentation using bone marrow aspirate concentrate (BMAC) and Arthrex AlloSync Pure. Bone marrow will be aspirated from the tibial tubercle and processed to obtain BMAC. The BMAC will be combined with AlloSync Pure and applied to the recipient socket and graft plug before allograft implantation. Participants will complete postoperative imaging and clinical outcome assessments over one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18 years of age or older.
- Scheduled to undergo osteochondral allograft transplantation of the knee with Dr. Jeffrey Macalena or Dr. Bradley Nelson.
- Medial or lateral femoral condyle osteochondral lesion deemed appropriate for treatment with osteochondral allograft transplantation.
- Able to understand and provide informed consent.
- Willing and able to comply with all study procedures and follow-up requirements.
Key exclusion criteria (8 listed)
- Younger than 18 years of age.
- Unable to provide informed consent, including individuals with absent, diminished, or fluctuating decision-making capacity.
- Unwilling or unable to comply with study procedures or follow-up requirements.
- Medical, psychiatric, or social condition that, in the opinion of the investigator, would interfere with study participation or interpretation of study results.
- Participation in another research study that could affect study outcomes, at the discretion of the investigator.
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 |
|---|---|---|
| Biologically Augmented Osteochondral Allograft TransplantationAlso: OCA Transplantation With BMAC and AlloSync PureParticipants will undergo osteochondral allograft transplantation of the knee with biologic augmentation. Bone marrow will be aspirated from the tibial tubercle and processed to obtain bone marrow aspirate concentrate (BMAC). BMAC will be mixed with Arthrex AlloSync Pure to create a biologic slurry. This mixture will be applied to the base of the recipient socket and along the walls of the graft plug before implantation of the osteochondral allograft. Participants will receive routine postoperative care and complete scheduled follow-up assessments. | Procedure or surgery | Biologically Augmented Osteochondral Allograft Transplantation |
Primary outcome
Osteochondral Allograft Incorporation Assessed by MRI
Time frame: 6 months after surgery
Osteochondral allograft incorporation will be assessed using magnetic resonance imaging (MRI) at 6 months after surgery. MRI findings will be evaluated using the Osteochondral Allograft MRI Scoring System (OCAMRISS) and other radiographic indicators of graft incorporation. Results will be summarized descriptively.
18 secondary outcomes
Osteochondral Allograft Incorporation at 12 Weeks
Time frame: 12 weeks after surgery
Osteochondral Allograft Incorporation at 12 Months
Time frame: 12 months after surgery, if clinically indicated
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, 1 week, 6 weeks, 12 weeks, 6 months, and 1 year after surgery
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 1 week
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 6 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 12 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 6 months
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 1 year after surgery
Change in Pain Measured by Visual Analog Scale (VAS)
Time frame: Baseline
Change in Pain Measured by Visual Analog Scale (VAS)
Time frame: 1 week
Change in Pain Measured by Visual Analog Scale (VAS)
Time frame: 6 weeks
Change in Pain Measured by Visual Analog Scale (VAS)
Time frame: 12 weeks
Change in Pain Measured by Visual Analog Scale (VAS)
Time frame: 6 months
Change in Pain Measured by Visual Analog Scale (VAS)
Time frame: 1 year after surgery
Radiographic Evidence of Graft Incorporation and Healing
Time frame: Through 1 year after surgery
Postoperative Complications and Adverse Events
Time frame: From surgery through 1 year after surgery
Subsequent Procedures Related to Index Surgery
Time frame: From surgery through 1 year after surgery
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 2 Nov 2026.
Related trials for Osteochondral Defect
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
Enrolling by invitationPhase 3
A RCT of Collagen Scaffold for the Repair of Talus Cartilage Injury
Cartilage Defects, Talus Osteochondral Defect
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
RecruitingPhase 3
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Chondral Defect, Osteochondritis Dissecans (OCD)
Active, not recruiting
Early Feasibility Study of Cartilage Defect Repair
Osteoarthritis, Hip, Femoroacetabular Impingement
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.
Jeffrey Macalena, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biologically Augmented Osteochondral Allograft Transplantation in people with Osteochondral Defect and Articular Cartilage Defect, run by University of Minnesota 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 8 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: opening soon, as of the sponsor's last update on 2 Nov 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?
Contact Anne Paulison (612-625-3526, pauli098@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteochondral Allograft Incorporation Assessed by MRI (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.