This is the question we get more often than any other. We get calls and emails frequently from patients and their families asking about our clinical trials, how can they participate, and when our products will finally be available. We are thrilled to report that enrollment for the first site of the ReNew Hip clinical trial is underway! FDA granted permission for CytexOrtho to host two sites for our pilot trial for the ReNew Hip implant. The first site at Washington University Hospital in St. Louis began screening interested patients in November 2025. Read below for details on the trial and steps towards enrollment!

The following is a list of the full inclusion and exclusion criteria approved by FDA. Eligibility for trial participation will be determined by the physicians performing the surgeries after a medical evaluation. We will provide contact information and instructions for how to request participation just as soon as we can!

In order to be eligible to participate in this study, subjects must meet all of the following 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 cm2 in area) on the femoral head (confirmed by MRI), without an opposing lesion that can be treated with a single ReNewTM 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

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 with a 3-year extension:

a. 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

b. 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

Subjects who meet any of the following criteria will be excluded from participating in this study:

1. Smoker (< 1 month cessation of smoking)

2. Type 1 or Type 2 Diabetes

3. Systemic Steroid use in past 3 months

4. Coxa plana, coxa magna, or proximal femoral focal deficiency on the femoral head

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 heads is:

a. outside of the 46 – 56 mm range in either anteroposterior diameter or lateral diameters

b. an aspherical head deformity

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 devices (polycarprolactone)

21. Is a prisoner

The ReNew Hip implant safety trial is taking place at Washington University in St. Louis at the clinic of Dr. Jeff Nepple and Dr. John Clohisy. Contractual negotiations for a second location are underway, but not yet complete.

Yes, all clinical visits and the ReNew Hip implant surgery will take place in-person at the clinical site(s) conducting the trial. On-site clinical visits include an initial screening visit, a visit for surgery, and follow up visits at 1, 3, 6, 12, 24, 36, 48, and 60 months after surgery. Limited patient stipends are available to help offset any expenses associated with participation in the trial.

Enrollment eligibility will be determined by the surgeons who are conducting the clinical trial after review of your medical history, symptoms, medical images such as MRIs and x-rays, and the results of the initial screening visit at the surgeon’s clinic. We recommend that you start by having your local physician review the inclusion and exclusion criteria posted at clinicaltrials.gov (Clinical Trial ID NCT06823089) and in the FAQ “Who can participate in the ReNew Hip clinical trial?” to determine if you are a likely candidate. If you seem to be a good fit, then you or your physician may contact the clinic conducting the trial for consideration and to have your questions answered about what is required to be considered for enrollment. After the initial on-site screening visit, the operating surgeon will decide if you are eligible and notify you. If you are, you can ask any additional questions you may have and then decide whether or not you would like to enroll in the trial.

For additional questions or to inquire about enrolling in the trial, please reach out to us at info@cytexortho.com.

Medical product development is a slow process by design, in order to ensure that medical products (i.e. medicines, devices, diagnostics) in the US are safe and work as intended. That is why CytexOrtho and all biomedical products companies go through lengthy and expensive clinical trials.

A quick internet search will reveal a couple of different – and potentially confusing – FDA medical device approval processes. 

CytexOrtho’s implanted devices fall under what is called an FDA Class III device, and it is further categorized under the premarket approval (PMA) path for brand new products, in contrast to add-ons to existing products. The PMA route is the most rigorous of FDA’s various pathways to market for medical devices.

We have provided a timeline outlining the typical PMA stages involved in getting a new device to market to give you an idea of what product development entails from brainstorming to product availability.

CytexOrtho’s potential future products are currently being tested in a variety of preclinical testing models. We have published many of our studies to date, and we have also shared these results with FDA. Our data, to date, provide evidence that our implant technology has potential for treating pre-arthritic lesions as well as early- to moderate-stage OA. In addition to our lead product, ReNew Hip, which is in a clinical trial, we are testing our technology for other joints in the body, such as knees and shoulders, and working on second-generation versions of our implants, that include a pre-grown cartilage layer for patients who may need it.

View the image on the right to see our current progress in the FDA approval process.