Donor cartilage plugs aim to fix damaged knees
NCT ID NCT06216756
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether using donated cartilage and bone cores can repair damaged knee cartilage in people aged 12 to 60. The damaged area is replaced with a preserved donor plug. The goal is to see if this improves knee function and reduces pain over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cryopreserved donor cartilage and bone core (osteochondral allograft)
- What this could lead to
- If successful, this could provide a reliable option for repairing knee cartilage damage, reducing pain and improving mobility without needing a joint replacement.
- What could go wrong
- This is an early-stage, single-arm study with no comparison group, so results may be less definitive. The graft may not integrate well, and there are risks of infection or graft failure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2024
- Expected to finish
-
Mar 2031
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 to 60 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients are ≥12 years and ≤ 60 years of age at the time of surgery. * Symptomatic patient presenting with moderate to severe pain in the index knee - unresponsive to conservative treatment (i.e., medication, bracing, physical therapy) and/or previous surgical intervention OR unsalvageable lesion that requires transplantation at the discretion of the treating physician. * Radiographically diagnosed, by MRI or CT scans, or through arthroscopy, to have a cartilage defect on the femoral condyle between 0.9-8.0 cm2 in size. * Will be having an osteochondral transplant procedure. * Has a mechanically stable knee or can be mechanically stabilized in the same procedure. * Has a normally aligned knee as confirmed by anatomic comparison to contralateral limb, or \<5° varus or valgus malalignment that has been corrected or will be corrected in same procedure. * Ipsilateral knee compartment has intact menisci or requires partial meniscectomy ≤ 50% resulting in stable menisci. * Confirmation MRI, CT scan, or arthroscopy obtained pre-operatively within 90 days of surgery * Willingness to follow standardized rehabilitation procedures. * Has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol. Exclusion Criteria: * Bipolar articular cartilage involvement (kissing lesions) of the ipsilateral compartment (i.e., \> than ICRS Grade 2 on the opposing articular surface). * Has had a prior osteochondral allograft transplant procedure in the same knee. * Will be receiving a meniscus allograft transplantation in the same procedure. * Body Mass Index (BMI)of ≥ 35 kg/m2. * Active malignancy: undergoing treatment for tumor or boney traumatic injury or a history of any invasive malignancy (except non-melanoma skin cancer) unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years. * Clinical and/or radiographic disease in the affected joint that includes generalized osteoarthritis, gout or a history of gout or pseudo-gout. * Active local microbial infection or a systemic infection, including HIV, syphilis, Hepatitis B or Hepatitis C. * Currently immunologically suppressed or immunocompromised, or a medical condition requiring radiation and/or chemotherapy. * Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer, or uncontrolled diabetes. * Has a history of any inflammatory joint arthropathy. * Currently using/chronic on oral corticosteroids. * Received interarticular corticosteroid injection ≤ 90 days prior to surgery. * Received hyaluronic acid injections into the joint space ≤ 45 days prior to surgery. * Is a female patient who is pregnant. * Physically or mentally compromised (i.e., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his/her ability to participate in the clinical study. * Has a history of substance abuse- (including but not limited to recreational drugs, alcohol) or has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an in-patient substance abuse program. * Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol. * Is currently involved in a study of another investigational product for similar purpose or has been in the previous 90 days. * Has any contraindications for MRI. * Is having the procedure as part of a Worker's Compensation claim. * Is a ward of the state, prisoner, or transient.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Osteochondral defect are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
6 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Banner- University Medical Center- Phoenix Orthopedic and Sports Medicine Institute
RECRUITINGPhoenix, Arizona, 85006, United States
-
Cedars-Sinai Kerlan Jobe Institute
NOT_YET_RECRUITINGLos Angeles, California, 90045, United States
-
Rush Copley Medical Center
RECRUITINGAurora, Illinois, 60504, United States
-
Stanford Medicine-Orthopaedics and Sports Medicine in Redwood City
RECRUITINGRedwood City, California, 94063, United States
-
University of California San Francisco
RECRUITINGSan Francisco, California, 94158, United States
-
University of Kentucky Research Foundation
RECRUITINGLexington, Kentucky, 40506, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.