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

Recruiting at 3 trial locations

Overseen By Elizabeth Esterl, DNP, MS, RN

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: AlloSource

Must not be taking: Hyaluronic acid, Immunosuppressants

Disqualifiers: Obesity, Cancer, Infections, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 1 day

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Jill Bagdasarian

Principal Investigator

AlloSource

Beth Esterl

Principal Investigator

AlloSource

Elizabeth Esterl, DNP, MS, RN

Principal Investigator

AlloSource

Are You a Good Fit for This Trial?

Inclusion Criteria

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;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical intervention for cartilage defect repair using ProChondrix CR

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

7 visits (in-person) at 3, 6, 12, 24, 36, 48, and 60 months

What Are the Treatments Tested in This Trial?

Interventions

• ProChondrix CR

Who Is Running the Clinical Trial?

AlloSource

Lead Sponsor

Trials

10

Recruited

700+