This is a Prospective Evaluation of ProChondrix CR for the Repair of Articular Cartilage Defects on the Femoral Condyle and Patella



Status:Recruiting
Healthy:No
Age Range:18 - 60
Updated:3/30/2019
Start Date:March 18, 2019
End Date:December 30, 2026
Contact:Jeanine Bailey
Email:jbailey@allosource.org
Phone:720-873-4811

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A Prospective, Multi-Center Study Evaluating ProChondrix® CR for the Repair of Focal Articular Cartilage Defects in the Knee

The purpose of this clinical study is to evaluate the use of ProChondrix Cryopreserved
Osteochondral Allograft to obtain evidence of effectiveness, defined as an improvement in
physical function and pain, when used on a symptomatic cartilage defect on the femoral
condyle or patella in a mechanically stable knee.


Inclusion Criteria:

- Patient is ≥18 and ≤ 60 years old 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;

- Radiographically diagnosed, by MRI, or through arthroscopy, to have a cartilage defect
on the femoral condyle or patella between ≥ 1 cm2 and ≤ 5 cm2, measured as a rectangle
length x width;

- Will be having a marrow stimulation plus ProChondrix CR procedure;

- Has an intact meniscus (maximum of ≤50% resected);

- Have the ability to understand the requirements of the study, to provide written
informed consent, and to comply with the study protocol.

Exclusion Criteria:

- Has > 5° of varus or valgus deformity;

- Bipolar articular cartilage involvement (kissing lesions) of the ipsilateral
compartment (i.e. > than ICRS Grade 2 on the opposing articular surface);

- Associated damage to the underlying subchondral bone >2 mm requiring osseous repair;

- Requires concomitant ligament repair other than Anterior Cruciate Ligament (ACL) or
Medial Patella-Femoral Ligament (MPFL) reconstruction;

- 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:
osteoarthritis or avascular necrosis, gout or a history of gout or pseudogout,
osteochondritis dissecans with significant bone loss;

- Cartilage lesion location such that the implanted graft will not be adequately
shouldered;

- 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, chemotherapy or immunosuppression;

- Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer or
uncontrolled diabetes;

- Has a history of any inflammatory or connective tissue disease, such as, systemic
lupus erythematosus (SLE), Addison's disease, Crohn's disease, multiple sclerosis,
polychondritis or rheumatoid arthritis;

- Received hyaluronic acid injections into the joint space ≤ 90 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 (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 a ward of the state, prisoner, or transient.
We found this trial at
2
sites
1850 M Street Northwest
Washington, District of Columbia 20038
Principal Investigator: Scott Faucett, MD, MS
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mi
from
Washington,
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Cincinnati, Ohio 45247
Principal Investigator: David Argo, MD
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from
Cincinnati, OH
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