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This is a Prospective Evaluation of ProChondrix CR for the Repair of Articular Cartilage Defects on the Femoral Condyle and Patella

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ClinicalTrials.gov Identifier: NCT03873545
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
AlloSource

Tracking Information
First Submitted Date March 12, 2019
First Posted Date March 13, 2019
Last Update Posted Date July 3, 2019
Actual Study Start Date March 18, 2019
Estimated Primary Completion Date April 1, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2019)
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
Original Primary Outcome Measures
 (submitted: March 12, 2019)
Subjective International Knee Documentation Committee (IKDC) Score [ Time Frame: 60 months ]
Change History Complete list of historical versions of study NCT03873545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 26, 2019)
  • 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
  • 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
  • Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Scores [ Time Frame: 12, 24 and 60 months ]
    Assessment of repair cartilage structure
Original Secondary Outcome Measures
 (submitted: March 12, 2019)
  • Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months ]
  • SF-12 survey [ Time Frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months ]
  • Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Scores [ Time Frame: Baseline, 12, 24 and 60 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title This is a Prospective Evaluation of ProChondrix CR for the Repair of Articular Cartilage Defects on the Femoral Condyle and Patella
Official Title A Prospective, Multi-Center Study Evaluating ProChondrix® CR for the Repair of Focal Articular Cartilage Defects in the Knee
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 Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Cartilage Injury
  • Cartilage Damage
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 12, 2019)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2026
Estimated Primary Completion Date April 1, 2026   (Final data collection date for primary outcome measure)
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;
  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jeanine Bailey 720-873-4811 jbailey@allosource.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03873545
Other Study ID Numbers PRO-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party AlloSource
Study Sponsor AlloSource
Collaborators Not Provided
Investigators Not Provided
PRS Account AlloSource
Verification Date July 2019