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.
When patients suffer from arthritis in the hip joint and fail conservative treatment, the standard surgical approach is total joint arthroplasty, where the joint is entirely removed and replaced with artificial materials. While this procedure is suitable for less active or older individuals, it is not ideal for younger, more active patients. Despite this, the number of total hip replacements in younger patients is increasing, requiring significant lifestyle adjustments to extend the implant's lifespan. Even with these efforts, most patients will face at least one total joint revision in their lifetime, each carrying an increased risk of complications and decreased patient satisfaction. As a result, total hip replacements are generally not recommended for patients aged 40 to 65 who experience activity-limiting symptoms and have exhausted conservative treatments. The Cytex device offers an alternative treatment option for this patient population - those suffering from hip osteoarthritis (OA), unresponsive to conservative care, yet considered too young or active for total joint replacement. Notably, the Cytex implant preserves all pre-existing healthy bone stock, unlike traditional total hip resurfacing or arthroplasty procedures, allowing for future revision to conventional resurfacing or arthroplasty if needed. The investigational device for this study, the ReNew Hip Implant, is a bioabsorbable, highly porous implant designed with mechanical properties that closely mimic those of healthy articular cartilage. The implant features a bicomponent structure, combining a biomimetic 3D woven textile with a porous 3D-printed framework.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
15
Surgical Intervention
Washington University School of Medicine
St Louis, Missouri, United States
RECRUITINGTo 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
Time frame: 6, 12, and 60 months
The international Hip Outcome Tool-33 (iHOT-33)
Difference demonstrated between pre-op and post-op iHOT-33
Time frame: 6, 12, and 60 months
Radiographic
Imaging MRI of operative joint assessing the implant by MOCART 2.0 (modified), implant placement, joint effusion, and osteophytosis
Time frame: 6, 12, and 60 months
Kaplan Meier survivorship
Kaplan Meier survivorship of the ReNew Hip Implant in terms of revision and / or radiological migration
Time frame: 12, 24, and 60 months post-surgery
Patient Reported Outcome Measures
Difference demonstrated between pre-op and the post-op of all PROMs (mHHS, UCLA, PROMIS)
Time frame: 6, 12, 24, and 60 months post-surgery
Health economic outcomes
Surgical blood loss; Measured in ml blood
Time frame: Time Frame: Intra-operative
Health economic outcomes
Length of hospital stay; Measure of days spent in hospital
Time frame: Time Frame: Hospital admission to discharge
Health economic outcomes
Operative time - first incision into skin to time when last suture is applied
Time frame: Intra-operative
Health economic outcomes
Re-hospitalizations for hip issues; Re-hospitalizations number of re-admissions to hospital
Time frame: Time Frame: Up to 60 months
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