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Status:

UNKNOWN

Comparison of BioCart™II With Microfracture for Treatment of Cartilage Defects of the Femoral Condyle

Lead Sponsor:

ProChon Biotech Ltd

Conditions:

Symptomatic Cartilage Defects of the Femoral Condyle

Eligibility:

All Genders

16-60 years

Phase:

PHASE2

Brief Summary

BioCart™II is a novel scaffold seeded with autologous chondrocytes to be used to repair cartilage lesions of the knee. This study is designed to compare the efficacy and safety of BioCart™II treatment...

Detailed Description

Full thickness cartilage lesions are typically incapable of self repair, are a source of pain and morbidity and lead to early onset osteoarthritis. A classical method of treatment has been microfractu...

Eligibility Criteria

Inclusion

  • Age 16 to 60 years
  • Femoral condyle lesion (medial, lateral or trochlea)
  • Single contained lesion
  • Symptomatic (moderate to severe pain on VAS)
  • Caused by trauma or OCD
  • Depth of lesion up to 6 mm
  • Size of lesion 1.5-7.5 cm2
  • No general bone or cartilage pathology
  • No limb mal-alignment (long leg standing X-ray)
  • Mechanically stable knee
  • Accompanying pathology menisectomy up to 50%
  • Willing and able to comply with protocol and undergo vigorous rehabilitation
  • Signed informed consent

Exclusion

  • Multiple cartilage lesions of the knee, other location than femoral condyle (medial, lateral or trochlear), deeper than 6 mm, smaller than 1.5cm2 or greater than 7.5cm2, mild symptoms, caused by reason other than trauma or OCD, unstable knee, accompanying pathology other than 50% menisectomy.
  • Hyaluronic acid knee injections in the past 3 months,
  • History of chronic bone or cartilage disorder, bilateral knee pain and/or cartilage lesion
  • History of any neoplastic disease, or chemotherapy treatment
  • Chronic steroid intake, chronic pain medication use for conditions other than the involved knee, use of blood thinners (during the past 10 days prior to enrollment)
  • History of allergy or atopic disease, sensitivity to blood products
  • Evidence of any significant systemic disease, known coagulopathies or acute injury that might compromise the patient's welfare
  • Pregnant or lactating women
  • Substance or alcohol abuse
  • Microfracture to the affected knee within the previous 2 years
  • Participation in concurrent trials
  • Participation in previous trials within 3 months
  • Malignancy
  • Taking specific drugs for osteoarthritis, such as chondroitin sulfate, diacerein, n-glucosamine, piaseledine, or capsaicin within 2 weeks of the baseline visit
  • Chronic use of anticoagulants
  • Uncontrolled diabetes
  • Active joint infection
  • Other unstable cardiac and pulmonary disorder
  • Liver enzymes (SGOT, SGPT, alkaline phosphatase) of more then two times the upper limit of normal or any other results that in the clinical investigator's mind is important clinically
  • Clinical and/or radiographic disease in the indexed affected joint that includes:
  • Osteoarthritis or avascular necrosis
  • Rheumatoid arthritis or a history of septic or reactive arthritis
  • Gout or a history of gout or pseudogout in the affected knee
  • Osteochondritis dissecans of the knee with significant bone loss
  • Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e \>than ICRS grade 2 on the opposing articular surface)
  • Associated damage to the underlying subchondral bone requiring an osteochondral graft
  • History of secondary arthropathies (i.e. sickle cell disease, Hemochromatosis, or autoimmune disease)
  • Receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee conditions
  • BMI \>40 kg/m2
  • Unable to undergo MRI
  • Any reasons making the patient a poor candidate in the eyes of the investigator

Key Trial Info

Start Date :

May 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2015

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00729716

Start Date

May 1 2008

End Date

May 1 2015

Last Update

April 17 2012

Active Locations (8)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (8 locations)

1

Tucson Orthopaedic Institute

Tucson, Arizona, United States, 85712

2

Southeastern Orthopedic Center

Savannah, Georgia, United States, 31405

3

Sinai Hospital of Baltimore

Baltimore, Maryland, United States, 21215

4

Mount Sinai Medical Center

New York, New York, United States, 10029-6754