ReNew Hip Implant for Younger Hip Osteoarthritis Patients
ReNew Hip Implant
Arthritis+9
+ Bone Diseases
+ Joint Diseases
Device Feasibility Study
Summary
Study start date: November 6, 2025
Actual date on which the first participant was enrolled.This study aims to explore a new way of treating hip arthritis in younger, more active individuals who have not found relief with standard treatments. Typically, these patients might undergo a total hip replacement, which involves replacing the entire joint with artificial materials. However, this approach can lead to lifestyle changes and the need for future surgeries. The study investigates the potential of the Cytex device, an implant designed for patients aged 40 to 65, as a more suitable option. This device could help preserve the existing bone and allow for less invasive future treatments. Participants in this study will receive the ReNew Hip Implant, a type of implant that is designed to work like natural cartilage in the hip. The implant is made from materials that the body can absorb over time and features a structure similar to healthy cartilage. The goal is to see if this implant can effectively reduce symptoms and improve hip function. The study will monitor the patients' progress to evaluate how well the implant performs and its safety. This research could lead to improved treatment options for younger patients with hip arthritis, potentially reducing the need for more invasive surgeries.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Device Feasibility Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 14 to 64 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Washington University School of Medicine
St Louis, United StatesOpen Washington University School of Medicine in Google Maps