Femoroacetabular Impingement, Hip Dysplasia, Legg-Calvé-Perthes Disease, Osteoarthritis, Hip, Osteochondral Lesion, Osteonecrosis
Conditions
Keywords
articular cartilage, hip resurfacing, residual Perthes disease, post-Perthes deformity, femoral head deformity, secondary hip osteoarthritis, hip preservation surgery, adolescent hip deformity, adult hip deformity, avascular necrosis of femoral head, early-stage avascular necrosis, Perthes sequelae, traumatic femoral head lesion
Brief summary
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.
Detailed description
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.
Interventions
DEVICEReNew Hip Implant
Surgical Intervention
Sponsors
Cytex Therapeutics, Inc.
MCRA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Prospective, non-randomized, non-comparative, single-arm, open-label, multicenter, clinical study
Eligibility
Sex/Gender
ALL
Age
14 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. BMI \< 35 3. Failed at least 6 weeks of conservative treatment (e.g., anti-inflammatory pain medications, physical therapy, injections) 4. 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) 5. Loss of articular cartilage integrity (\~1 - 6 cm\^2 in area) on the femoral head (confirmed by MRI), without an opposing lesion, that can be treated with a single ReNew Hip Implant 6. Radiographic assessment with joint space width \> 2 mm (verified by x-ray) 7. Meets an acceptable preoperative medical clearance and is free of conditions that would pose excessive operative risk, in the opinion of the investigator 8. Given consent to participate in the study 9. Able to understand the purpose of the study, his/her role, and is available for follow-up for the duration of the study: 1. Subject has signed an IRB (Institutional Review Board) approved Informed Consent Form agreeing to participate in the extension study after the nature, scope, and possible consequences of the study have been explained in an understandable form 2. Subject is able to fully understand the purpose of the study, his/her role as a participant in the study, and plans to be available through five years post-operative follow-up
Exclusion criteria
1. 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. 2. Type 1 or Type 2 Diabetes 3. Systemic steroid use in the 3 months prior to screening 4. Coxa plana, coxa magna, or proximal femoral focal deficiency on the femoral head that would result in implant mismatch of the femoral head contour 5. Any acute or chronic condition that would limit the ability of the patient to participate in the study (e.g., COPD, congestive heart failure), 6. Bleeding disorders 7. Current cancer (with the exception of non-melanoma skin cancer) 8. Pregnancy or planning to become pregnant during the study period 9. Active infection or sepsis 10. History of local hip infection 11. Known metastatic or neoplastic disease 12. Conditions that may interfere with implant survival or outcomes (e.g., severe dysplasia) 13. Life expectancy less than 2 years 14. Intra-articular therapy within 3 months of enrollment 15. Inadequate bone stock (as determined by SCORE or MORES assessment) to support the device 16. Femoral head is: 1. outside of the 46 - 56 mm range in either anteroposterior diameter or lateral diameters or 2. an aspherical head deformity that results in contour mismatch of 16a 17. Moderate to severe renal insufficiency 18. Emotional or neurological condition that would preempt ability or willingness to participate in the study 19. Above the knee amputation of the contralateral or ipsilateral leg 20. Known allergies to the components of the device (polycaprolactone) 21. Is a prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To establish initial safety (adverse events and device related serious adverse events) and effectiveness (pain and function) of the ReNew Hip Implant | 6, 12, and 60 months | 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) | 6, 12, and 60 months | Difference demonstrated between pre-op and post-op iHOT-33 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic | 6, 12, and 60 months | Imaging MRI of operative joint assessing the implant by MOCART 2.0 (modified), implant placement, joint effusion, and osteophytosis |
| Kaplan Meier survivorship | 12, 24, and 60 months post-surgery | Kaplan Meier survivorship of the ReNew Hip Implant in terms of revision and / or radiological migration |
| Patient Reported Outcome Measures | 6, 12, 24, and 60 months post-surgery | Difference demonstrated between pre-op and the post-op of all PROMs (mHHS, UCLA, PROMIS) |
| Health economic outcomes | Time Frame: Intra-operative | Surgical blood loss; Measured in ml blood |
Countries
United States
Outcome results
None listed