Back to search results

Cryopreserved Osteochondral Allograft Cores for Knee Lesions

This study is evaluating a procedure using cryopreserved osteochondral allograft cores (donated bone and cartilage tissue that has been frozen) to treat damage in the knee. Specifically, it's for people aged 12 to 60 who have a full-thickness cartilage lesion (Grade 3 or 4) on the femoral condyle (the rounded end of the thigh bone in the knee joint) that causes pain and hasn't improved with other treatments. The main goal is to see how well this procedure works by tracking your knee function over time. The study is currently enrolling 68 participants.

Study design
This is an interventional study with a planned enrollment of 68 participants. The study is designed to evaluate the effectiveness of the osteochondral transplant procedure.
What's involved
You would undergo an osteochondral transplant procedure and have follow-up visits at 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 60 months (5 years) after the procedure to assess long-term outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06216756

Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee

Recruiting
NAAges 12–60InterventionalTreatment
AlloSource
~68 participants
Updated 2025-11-25 on ClinicalTrials.gov
What's tested:osteochondral transplant on the femoral condyle

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
International Knee Documentation Committee (IKDC) score
Measured over 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months post procedure

Conditions

Osteochondral Defect

Explore related trials

Osteochondral Defect

NCT06216756

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Banner- University Medical Center- Phoenix Orthopedic and Sports Medicine Institute

    Phoenix, Arizonastudy coordinator listed

    Recruiting

  • Cedars-Sinai Kerlan Jobe Institute

    Los Angeles, Californiastudy coordinator listed

    Not yet recruiting

  • Rush Copley Medical Center

    Aurora, Illinoisstudy coordinator listed

    Recruiting

  • Stanford Medicine-Orthopaedics and Sports Medicine in Redwood City

    Redwood City, Californiastudy coordinator listed

    Recruiting

  • University of California San Francisco

    San Francisco, Californiastudy coordinator listed

    Recruiting

  • University of Kentucky Research Foundation

    Lexington, Kentuckystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Elizabeth Esterl, DNP, MS, RN
[email protected]
7207326231
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • International Knee Documentation Committee (IKDC) score3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months post procedure

    Change of physical functioning and pain from baseline as assessed by the subjective International Knee Documentation Committee (IKDC) score. Scores are reported on a 0-100 scale, with low scores indicating worse outcomes and higher scores indicating better outcomes.