A Prospective, Multicenter Single Arm Feasibility Study of the Safety and Performance of GRADION* Hip Total Cartilage Replacement (TCR)* in the Treatment of Degenerative Joint Disease of the Hip - GRADION* TCR

Biomimedica, Inc.0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•Primary hip surgery for Noninflammatory Degenerative Joint Disease (NIDJD) such as osteo/degenerative arthritis, and is indicated for cartilage replacement
•Skeletally mature or at least 18 years of age and has normal anatomy
•Patient signs the Informed Consent form
•Failed medical management
•There will be size limitations on patients also - available size range is 46mm -52mm.

•Allergic to polyether urethane, sodium polyacrylate, bone cement or any of its components
•Previous fusion, acute femoral neck fracture and/or above knee amputation
•Revision of any previous hip procedure
•Slipped femoral capital epiphysis (SCFE)
•Rheumatoid arthritis
•Active infection, tumor, or multiple cysts
•Biomechanically compromised (e.g. coxa valga, coxa vara, Legg-Calve-Perthes, hip dyspasia)
•Women who are pregnant; if of child bearing years, must have a negative serum βHCG within 24 hours of procedure
•Impingement
•Neurological or musculoskeletal disease that may adversely affect gait or weight bearing
•Previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device
•Active hepatitis or HIV infection
•Prisoners
•Body Mass Index (BMI) of >35
•Neuropathic joints
•Severe documented psychiatric disease
•Require structural bone grafts
•Ipsilateral girdlestone
•NOTE: In cases of questionable bone stock, a Dual-Energy X-ray Absorptiometry (DEXA) scan may be necessary to assess inadequate bone stock.

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