Recruiting

Cryopreserved Osteochondral Allograft

Sponsor:

AlloSource

Code:

NCT06216756

Conditions

Osteochondral Defect

Eligibility Criteria

Sex: All

Age: 12 - 60

Healthy Volunteers: Not accepted

Interventions

osteochondral transplant on the femoral condyle

Study Details

Brief summary:

The primary objective of this study is to obtain evidence of the effectiveness of Cryopreserved Osteochondral Allograft Core in the treatment of osteochondral lesions on the femoral condyle.

Conditions

Osteochondral Defect

Study ID

NCT06216756

Start date

Dec 1, 2024

Status verified date

Nov, 2025

Completion date

Mar, 2031

Anticipated

Primary completion date

Mar, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

68 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Osteochondral transplant on the femoral condyle

Eligible and enrolled patients will receive one or more cryopreserved osteochondral allograft core as part of their osteochondral transplant procedure

Interventions

osteochondral transplant on the femoral condyle

Patients between the ages of ≥12 years and ≤ 60 years who have a symptomatic full-thickness cartilage lesion (Grade 3 or 4) on the femoral condyle, in a mechanically stable knee, or is being mechanically stabilized in the same procedure, between 0.9-8.0 cm2 in size, and cystic changes requiring osseous repair, as confirmed by MRI , CT scan, or arthroscopy and will undergo a osteochondral transplant by removing the damaged cartilage and replacing that cartilage with a cryopreserved osteochondral allograft core.

Primary outcome measure

  • International Knee Documentation Committee (IKDC) score [ Time Frame: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months post procedure ]

Central Contacts and Locations

Central contacts

Elizabeth Esterl, DNP, MS, RN

7207326231eesterl@allosource.org

Paige McHenry, MS, ATC, CCRA

2154997062pmchenry@allosource.org

Locations

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

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Maria Jimenez, CRC II

602-614-8549Maria.Jimenez2@bannerhealth.com

Principal Investigator:

Thomas Carter, MD

Stanford Medicine-Orthopaedics and Sports Medicine in Redwood City

Recruiting

Redwood City, California, United States, 94063

Contacts

Allen Seo

allenseo@stanford.edu

Principal Investigator:

Seth Sherman, MD

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Jocelyn Carpio

jocelyn.carpio@ucsf.edu

Principal Investigator:

Drew Lansdown, MD

Rush Copley Medical Center

Recruiting

Aurora, Illinois, United States, 60504

Contacts

Starlyn Nadeau, RN

630-361-4267starlyn_nadeau@rush.edu

Principal Investigator:

Brian E Walczak, DO, PhD

University of Kentucky Research Foundation

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Caitlin Conley

859-257-1939caitlin.conley2@uky.edu

Principal Investigator:

Austin Stone, MD, PhD

More Information

Sponsor

AlloSource

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AlloSource on 2025-11-25.