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A Phase 3 Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART® 3D, Compared to Microfracture in the Treatment of Articular Cartilage Defects.

The purpose of this research study is to assess the pain, stiffness and physical function of the knee in patients with an articular cartilage defect of the knee. Participants will receive one of two possible surgical procedures. One surgical procedure, which is the investigational procedure under study, utilizes the Novocart® 3D autologous cartilage implant system. The other possible procedure is called Microfracture and is one of the current standard of care options to treat this condition. Both surgical procedures will be followed by pain and knee function assessments and a course of physical rehabilitation.
Andrea Horne at ahorne@pennstatehealth.psu.edu or 717-531-7127
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT01957722
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Inclusion Criteria:
age 18 to 65
symptomatic knee pain indicative of articular cartilage defects
inadequate response to conservative treatment
Full range of motion of the affected joint
Normally functioning contralateral knee
Exclusion Criteria:
Severe obesity (BMI > 40)
Surgery on the contralateral knee within 6 months prior to the scheduled arthoscopy
intra-articular injections within 1 month of surgery
Prior release and excision of scar tissue except isolated lateral release on target knee
Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture on target knee (Note: prior debridement and lavage are acceptable if more than three months have passed.)
Sports Medicine, Muscle & Bone
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Location
Hershey, PA