Noninflammatory Degenerative Joint Disease osteoarthritis
Conditions
Interventions
During surgery, patients receive an incision at the side of the affected hip.
During the procedure, a small portion of bone is removed and the GRADION *
implant is placed on each bone (acetabulum an
Sponsors
Biomimedica, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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 • AVN • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to demonstrate the safety of the investigational device GRADION* Hip Total Cartilage Replacement (TCR)*. This will be assessed by adverse events at 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to assess the performance of the investigation device GRADION* Hip Total Cartilage Replacement (TCR)*. This will be assessed by the Harris Hip Score, which measures hip related function and pain assessment. Other information regarding the following outcomes will be gathered and interpreted by the treating surgeon in the course of routine patient evaluation: • Operative site related adverse events; • Physical examination data; and • Clinically-indicated anterior-posterior and lateral x-ray images. • Magnetic Resonance Imaging (MRI) • All adverse events, including information concerning the nature, onset, duration, severity, and relationship to the device and operative procedure Radiographic assessment will be completed by an independent reviewer and includes these parameters: • Joint height/spacing • Cement interface/zones for radiolucency | — |
Countries
Netherlands
Outcome results
None listed