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

NCT03873545 | Active Not Recruiting

• 1 other identifier: PRO-002
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 3

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.

Conditions

Cartilage Injury; Cartilage Damage

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Subjective International Knee Documentation Committee (IKDC) Score

  Change in physical pain and function as assessed by IKDC score from baseline to 60 months post-surgery

  Baseline, 3, 6, 12, 24, 36, 48 and 60 months

Secondary Outcomes (3)

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  Baseline, 3, 6, 12, 24, 36, 48 and 60 months

• SF-12 survey

  Baseline, 3, 6, 12, 24, 36, 48 and 60 months

• Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Scores

  12, 24 and 60 months

Interventions

Cryopreserved Osteochondral Allograft PROCEDURE

This tissue is a laser-etched, cryopreserved fresh osteochondral allograft that was developed as a single-stage alternative for articular cartilage restoration.

Also known as: ProChondrix CR

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• AlloSource: lead

Study Sites (3)

Midwest Orthopaedics at Rush

Chicago, Illinois, 60612, United States

Location

University of Kentucky Research Foundation

Lexington, Kentucky, 40506, United States

Location

Beacon Orthopaedics & Sports Medicine

Cincinnati, Ohio, 45247, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 13, 2019
• Study Start: March 18, 2019
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)