RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective, Open Label, Single-Arm, Multi-Center Study Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee

Quick Facts

Study Start:2024-12-01

Study Completion:2031-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06216756

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Patient is ≥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 through arthroscopy, to have a cartilage defect on the femoral condyle between 2.0-8.0 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. * MRI or CT scan 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.	* Bipolar articular cartilage involvement (kissing lesions) of the ipsilateral compartment (i.e., \> than ICRS Grade 2 on the opposing articular surface). * Cystic changes present in the underlying subchondral bone \>12 mm requiring osseous repair. * 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 prior or pending treatment for 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 inpatient 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.

Inclusion Criteria

Exclusion Criteria

* Patient is ≥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 through arthroscopy, to have a cartilage defect on the femoral condyle between 2.0-8.0 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.
* MRI or CT scan 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.

* Bipolar articular cartilage involvement (kissing lesions) of the ipsilateral compartment (i.e., \> than ICRS Grade 2 on the opposing articular surface).
* Cystic changes present in the underlying subchondral bone \>12 mm requiring osseous repair.
* 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 prior or pending treatment for 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 inpatient 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.

Contacts and Locations

Study Contact

Elizabeth Esterl, DNP, MS, RN

CONTACT

7207326231

eesterl@allosource.org

Nicole Litton, BS

CONTACT

2815076061

nlitton@allosource.org

Study Locations (Sites)

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

Phoenix, Arizona, 85006

United States

Cedars-Sinai Kerlan Jobe Institute

Los Angeles, California, 90045

United States

Stanford Medicine-Orthopaedics and Sports Medicine in Redwood City

Redwood City, California, 94063

United States

University of California San Francisco

San Francisco, California, 94158

United States

Rush Copley Medical Center

Aurora, Illinois, 60504

United States

University of Kentucky Research Foundation

Lexington, Kentucky, 40506

United States

Collaborators and Investigators

Sponsor: AlloSource

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-01

Study Completion Date2031-03

Study Record Updates

Study Start Date2024-12-01

Study Completion Date2031-03

Terms related to this study

Additional Relevant MeSH Terms

Osteochondral Defect