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

AlloSource3 sites in 1 country34 target enrollmentMarch 18, 2019

ConditionsCartilage Injury Cartilage Damage

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cartilage Injury
Sponsor: AlloSource
Enrollment: 34
Locations: 3
Primary Endpoint: Subjective International Knee Documentation Committee (IKDC) Score
Status: Active, not recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

March 18, 2019

End Date

December 30, 2028

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AlloSource

Responsible Party

Sponsor

Eligibility 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;

Outcomes

Primary Outcomes

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 Outcomes

Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Scores(12, 24 and 60 months)
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)