ReNew Hip Implant for Hip Injuries

Overseen By Christine Estes

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Cytex Therapeutics, Inc.

Must not be taking: Systemic steroids

Disqualifiers: Nicotine use, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: Surgery and immediate recovery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the ReNew Hip Implant to evaluate its effectiveness for individuals with specific hip problems. It targets those whose hip disease has resulted in cartilage loss in the hip joint, causing persistent pain unrelieved by medication or physical therapy. The trial seeks participants who have experienced this type of hip pain for at least three months and are considering surgery. As an unphased trial, it offers participants the chance to contribute to important research that could lead to new treatment options for hip pain.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have used systemic steroids in the past 3 months or had intra-articular therapy within 3 months of enrollment, you may not be eligible to participate.

What prior data suggests that the ReNew Hip Implant is safe for hip injuries?

Research has shown that the ReNew Hip Implant is as safe and effective as traditional hip replacements. This conclusion is based on studies of similar hip systems, which generally perform well for patients. However, some risks should be considered. Certain studies have found a higher chance of thigh bone fractures with specific hip implants, but it remains unclear if this applies to ReNew. Patients should always discuss with their doctor to understand the benefits and risks based on their health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ReNew Hip Implant is unique because it offers a potentially more durable and efficient solution for hip injuries compared to current options like traditional metal or ceramic hip replacements. Researchers are excited about this treatment because it is designed with advanced materials that may reduce wear and tear, leading to a longer lifespan of the implant. Additionally, it aims to improve patient mobility and comfort with a design that more closely mimics the natural movement of the hip joint, setting it apart from existing implants.

What evidence suggests that the ReNew Hip Implant is effective for hip injuries?

Research has shown that hip replacements, such as the ReNew Hip Implant being studied in this trial, are usually successful and long-lasting. One study found that 57.9% of hip replacements last more than 25 years. Another source indicates these implants typically last about 15 to 20 years. Many patients experience significantly less pain, with 80% reporting mild or no pain after hip revision surgery. Additionally, one-stage revision surgeries prove just as effective as two-stage surgeries in improving hip function and reducing pain. This suggests that hip implants can offer long-term benefits for individuals with hip injuries. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for people aged 14 to 55 with hip diseases like FAI or osteoarthritis, who've tried other treatments without success. They should have a BMI under 35, persistent symptoms for at least 3 months, and some cartilage loss in the hip but still enough joint space. Participants need medical clearance and must commit to follow-ups.

Inclusion Criteria

I am cleared for surgery without high risk and have agreed to join the study.

I have signed a consent form to participate in further study.

My BMI is below 35.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ReNew Hip Implant, a bioabsorbable, highly porous implant designed to mimic healthy articular cartilage

Surgery and immediate recovery

1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6, 12, 24, and 60 months post-surgery

60 months

Multiple visits (in-person and virtual) at 6, 12, 24, and 60 months

Long-term follow-up

Participants are monitored for long-term outcomes, including survivorship and health economic outcomes

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• ReNew Hip Implant

Trial Overview The ReNew Hip Implant is being tested as a surgical intervention for repairing damaged cartilage in the hip. The study aims to evaluate its safety and early feasibility in patients who haven't improved with conservative treatments.

How Is the Trial Designed?

Group I: Investigational Arm Experimental Treatment 1 Intervention

The investigation device for this study will be the ReNew Hip Implant.

Who Is Running the Clinical Trial?

Cytex Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

20+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9647039/

How long do revised and multiply revised hip replacements ... In 2019, a meta-analysis found that 57·9% of total hip replacements last over 25 years. Despite high overall success rates, some hip ...

2. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(18)31665-9/fulltext

How long does a hip replacement last? A systematic ... The 25-year pooled survival of hip replacements from case series was 77·6% (95% CI 76·0–79·2) and from joint replacement registries was 57·9% ( ...

3. hss.edu hss.edu/health-library/conditions-and-treatments/list/hip-revision

Hip Revision: When Your Hip Replacement Must Be ... Total hip replacement is a durable and highly successful operation and the associated implants usually last about 15 to 20 years.

4. evidence.nihr.ac.uk evidence.nihr.ac.uk/alert/one-stage-hip-revisions-are-as-good-as-2-stage-surgery-to-replace-infected-artificial-hips/

One-stage hip revisions are as good as 2-stage surgery Research found that one-stage hip revisions were as effective as 2-stage procedures at relieving pain and improving hip stiffness and function.

5. arthritis.org arthritis.org/health-wellness/treatment/joint-surgery/after-surgery/hip-replacement-success-rates

Hip Replacement Success Rates 80% - Of those in moderate pain before revision hip surgery reported mild or no pain after five years. 78% - Of those with severe pain before revision hip ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/p030042b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Resurfacing Hip System is as safe and effective as conventional total hip arthroplasty. The. CONSERVE® Plus Total Resurfacing Hip System ...

7. fda.gov fda.gov/medical-devices/safety-communications/zimmer-biomet-cpt-hip-system-femoral-stem-and-increased-risk-thigh-bone-fracture-fda-safety

Zimmer CPT Hip System: Increased Risk of Thigh Bone ... Recent research found a higher risk of thigh bone fracture after surgery with the CPT Hip System compared to hip replacement devices of a similar design.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06792539

Evaluate the Safety and Effectiveness of the Polymotion ... The goal of this clinical trial is to evaluate the safety and effectiveness of the Polymotion Hip Resurfacing (PHR) System compared to total hip ...

9. hca.wa.gov hca.wa.gov/assets/program/hip-resurfacing-lit-search-update-20120813.pdf

Safety and Efficacy of Hip Resurfacing Procedures New data from registries and peer-reviewed journals were investigated in this FDA report specifically looking for potential safety issues, ...

10. drugwatch.com drugwatch.com/hip-replacement/recalls/

Hip Replacement Recall | Causes and FDA Information Learn what caused companies to recall hundreds of metal-on-metal hip replacements. Read about hip implant FDA warnings & which implants have been pulled.