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

• ClinicalTrials.gov Identifier: NCT03873545
• Recruitment Status: Recruiting
• First Posted: March 13, 2019
• Last Update Posted: October 14, 2020
• Sponsor: AlloSource
• Information provided by (Responsible Party): AlloSource

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Cartilage Injury; Cartilage Damage	Procedure: Cryopreserved Osteochondral Allograft

Detailed Description:

This clinical study will use a multi-center, prospective design, to evaluate ProChondrix CR in approximately 80 patients who are scheduled to undergo treatment of a cartilage defect on the femoral condyle or patella.Patient follow-up will include a period of 60 months after surgery. During this follow-up period, each patient will be evaluated seven (7) times at: 3, 6, 12, 24, 36, 48 and 60 months after surgical intervention.

Study Design

• Study Type: Observational
• Estimated Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective, Multi-Center Study Evaluating ProChondrix® CR for the Repair of Focal Articular Cartilage Defects in the Knee
• Actual Study Start Date: March 18, 2019
• Estimated Primary Completion Date: April 1, 2026
• Estimated Study Completion Date: December 30, 2026

Groups and Cohorts

Intervention Details:

• Procedure: Cryopreserved Osteochondral Allograft
  This tissue is a laser-etched, cryopreserved fresh osteochondral allograft that was developed as a single-stage alternative for articular cartilage restoration.
  Other Name: ProChondrix CR

Outcome Measures

Primary Outcome Measures :

1. Subjective International Knee Documentation Committee (IKDC) Score [ Time Frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months ]
   Change in physical pain and function as assessed by IKDC score from baseline to 60 months post-surgery

Secondary Outcome Measures :

1. Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months ]
   Change of physical pain as assessed by KOOS score from baseline to 60 months post-surgery
2. SF-12 survey [ Time Frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months ]
   Change in functional health and well-being as assessed by SF-12 survey from baseline to 60 months post-surgery
3. Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Scores [ Time Frame: 12, 24 and 60 months ]
   Assessment of repair cartilage structure

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Skeletally mature patients between the ages of ≥18 and ≤ 60 who have a symptomatic cartilage defect (Grade 3 or 4) on the femoral condyle or patella, in a mechanically stable knee, or is being mechanically stabilized in the same procedure, between ≥ 1 cm2 and ≤ 5 cm2, measured as a rectangle length x width, as confirmed by MRI or arthroscopy.

Criteria

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.

Contacts and Locations

Contacts

Contact: Jeanine Bailey; 720-873-4811; jbailey@allosource.org

Contact: Jill Bagdasarian; 720-382-2742; jbagdasarian@allosource.org

Locations

United States, Kentucky

University of Kentucky Research Foundation; Recruiting

Lexington, Kentucky, United States, 40506

Contact: Austin Stone, MD 859-218-3065

Contact: Caitlin Conley, PhD (859) 257-1939

Principal Investigator: Austin Stone, MD

United States, Ohio

Beacon Orthopaedics & Sports Medicine; Recruiting

Cincinnati, Ohio, United States, 45247

Contact: David Argo, MD 888-773-4353 dargo@beaconortho.com

Contact: Daniele Schum 513-354-7796 dschum@beaconortho.com

Principal Investigator: David Argo, MD

Sponsors and Collaborators

AlloSource

Investigators

• Study Director: Jill Bagdasarian; AlloSource

More Information

• Responsible Party: AlloSource
• ClinicalTrials.gov Identifier: NCT03873545
• Other Study ID Numbers: PRO-002
• First Posted: March 13, 2019
• Last Update Posted: October 14, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AlloSource:

Cartilage; Cartilage Injury; Cartilage Repair; Cartilage Damage; Cartilage Lesion; Cartilage Defect