Any patient aged 14 or older up to 64 years of age with hip disease, resulting in loss of articular cartilage integrity on the femoral head (e.g., femoroacetabular impingement or other structural deformity), has failed conservative care, and is a candidate for surgical intervention to treat.
At least 14 years of age to no older than 64 years of age Subjects 14-21 years of age must have radiographic evidence of epiphyseal closure in the hip joint
BMI < 35
Failed at least 6 weeks of conservative treatment (e.g., anti-inflammatory pain medications, physical therapy, injections)
Duration of symptoms consistent with intra-articular disease (i.e., groin, lateral and/or posterior hip pain) that have persisted for at least 3 months)
Current users of nicotine in any form (e.g., cigarettes, e- cigarettes/vaping, chewing tobacco, nicotine patches, gum, lozenges), or individuals who have discontinued nicotine use less than 30 days prior to screening.
Type 1 or Type 2 Diabetes
Systemic steroid use in the 3 months prior to screening
Coxa plana, coxa magna, or proximal femoral focal deficiency on the femoral head that would result in implant mismatch of the femoral head contour
Single group
ReNew Hip Implant
DeviceSurgical Intervention
To establish initial safety (adverse events and device related serious adverse events) and effectiveness (pain and function) of the ReNew Hip Implant
Incidence rate of all adverse events including general adverse events, procedure related events and device related events. Incidence rate of device-related serious adverse events
The international Hip Outcome Tool-33 (iHOT-33)
Difference demonstrated between pre-op and post-op iHOT-33
Radiographic
Imaging MRI of operative joint assessing the implant by MOCART 2.0 (modified), implant placement, joint effusion, and osteophytosis
Kaplan Meier survivorship
Kaplan Meier survivorship of the ReNew Hip Implant in terms of revision and / or radiological migration
Patient Reported Outcome Measures
Difference demonstrated between pre-op and the post-op of all PROMs (mHHS, UCLA, PROMIS)
Health economic outcomes
Surgical blood loss; Measured in ml blood
Click on the lead sponsor to view all of their trials.
Cytex Therapeutics, Inc.
Lead sponsor
MCRA
Collaborator
