This is the question we get more often than any other. We get calls and emails almost daily from patients and their families asking about our clinical trials, how can they participate, and when our products will finally be available.

While we don’t have a specific date yet, we’re thrilled to announce that we’ve received clearance to conduct a clinical trial of our ReNew™ Hip implant in 2025. We’re busy putting together the details, so stay tuned! (Check out “What’s next for CytexOrtho?” below for a sneak peek!)

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 55 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

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. We are currently getting the agreements with the clinical sites in place to conduct the clinical trial with the ReNew™ hip implant.

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