Prospective Evaluation of ProChondrix CR for Repair of Articular Cartilage Defects on Femoral Condyle and Patella

Active, not recruiting

• Conditions: Cartilage Injury; Cartilage Damage

• Registration Number: NCT03873545
• Lead Sponsor: AlloSource

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-3-12
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Patient is =18 and = 60 years old at the time of surgery;<br><br> - Symptomatic patient presenting with moderate to severe pain in the index knee -<br> unresponsive to conservative treatment (i.e. medication, bracing, physical therapy)<br> and/or previous surgical intervention;<br><br> - Radiographically diagnosed, by MRI, or through arthroscopy, to have a cartilage<br> defect on the femoral condyle or patella between = 1 cm2 and = 5 cm2, measured as a<br> rectangle length x width;<br><br> - Will be having a marrow stimulation plus ProChondrix CR procedure;<br><br> - Has an intact meniscus (maximum of =50% resected);<br><br> - Have the ability to understand the requirements of the study, to provide written<br> informed consent, and to comply with the study protocol.<br><br>Exclusion Criteria:<br><br> - Has > 5° of varus or valgus deformity;<br><br> - Bipolar articular cartilage involvement (kissing lesions) of the ipsilateral<br> compartment (i.e. > than ICRS Grade 2 on the opposing articular surface);<br><br> - Associated damage to the underlying subchondral bone >2 mm requiring osseous repair;<br><br> - Requires concomitant ligament repair other than Anterior Cruciate Ligament (ACL) or<br> Medial Patella-Femoral Ligament (MPFL) reconstruction;<br><br> - Body Mass Index (BMI)of = 35 kg/m2;<br><br> - Active malignancy: undergoing treatment for tumor or boney traumatic injury or a<br> history of any invasive malignancy (except non-melanoma skin cancer), unless the<br> patient has been treated with curative intent and there have been no clinical signs<br> or symptoms of the malignancy for at least 5 years;<br><br> - Clinical and/or radiographic disease in the affected joint that includes:<br> osteoarthritis or avascular necrosis, gout or a history of gout or pseudogout,<br> osteochondritis dissecans with significant bone loss;<br><br> - Cartilage lesion location such that the implanted graft will not be adequately<br> shouldered;<br><br> - Active local microbial infection or a systemic infection, including prior or pending<br> treatment for HIV, syphilis, Hepatitis B or Hepatitis C;<br><br> - Currently immunologically suppressed or immunocompromised, or a medical condition<br> requiring radiation, chemotherapy or immunosuppression;<br><br> - Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer<br> or uncontrolled diabetes;<br><br> - Has a history of any inflammatory or connective tissue disease, such as, systemic<br> lupus erythematosus (SLE), Addison's disease, Crohn's disease, multiple sclerosis,<br> polychondritis or rheumatoid arthritis;<br><br> - Received hyaluronic acid injections into the joint space = 90 days prior to surgery;<br><br> - Is a female patient who is pregnant;<br><br> - Physically or mentally compromised (i.e. being currently treated for a psychiatric<br> disorder, senile dementia, Alzheimer's disease) in a manner that would compromise<br> his/her ability to participate in the clinical study;<br><br> - Has a history of substance abuse (recreational drugs, alcohol) or has been treated<br> in the last 6 months before enrollment for alcohol and/or drug abuse in an<br> in-patient substance abuse program;<br><br> - Patients who, in the opinion of the Investigator, would not be able or willing to<br> comply with the protocol;<br><br> - Is currently involved in a study of another investigational product for similar<br> purpose or has been in the previous 90 days;<br><br> - Has any contraindications for MRI;<br><br> - Is a ward of the state, prisoner, or transient.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective International Knee Documentation Committee (IKDC) Score

Secondary Outcome Measures

Name	Time	Method
Knee injury and Osteoarthritis Outcome Score (KOOS);SF-12 survey;Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Scores