Hip Implant for Hip Replacement

Enrolling by invitation at 9 trial locations

Overseen By Ryan Boylan, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Infection, Osteoporosis, Metabolic disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Varies

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new hip implant called the G7 Freedom Constrained Vivacit-E Liners. The goal is to evaluate the safety and effectiveness of this implant for individuals needing a hip replacement, whether for the first time or as a revision. It targets those with joint issues such as severe arthritis or a high risk of hip dislocation. Ideal participants experience ongoing hip problems that significantly affect daily life and are considering surgery. Participants must also commit to attending follow-up visits as part of the study. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future hip replacement options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this hip implant is safe for hip replacement?

Research shows that the G7 Freedom Constrained Vivacit-E Liners are used in both first-time and repeat hip replacement surgeries. These liners belong to a system that can be adjusted to meet different patients' needs, especially in complex hip surgeries.

Regarding safety, various studies have tested these liners to ensure long-term safety and effectiveness. So far, they have shown adaptability in surgeries, which is promising. However, detailed information about any side effects is lacking, indicating a need for more research to fully understand their safety.

Since this trial isn't in an early phase, the treatment has already undergone safety testing and has been well-tolerated in initial studies. However, as with any medical treatment, ongoing monitoring is important as more people use it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The G7 Freedom Constrained Vivacit-E Liners are unique because they combine advanced materials with an innovative design to enhance hip replacement outcomes. Unlike traditional hip implants, which may use standard polyethylene, this system incorporates Vivacit-E, a highly durable and oxidation-resistant material, potentially reducing wear and increasing longevity. Researchers are excited about this treatment because it offers a tailored approach for both primary and revision hip replacements, promising improved stability and a lower risk of dislocation, which are critical factors for patients undergoing total hip arthroplasty.

What evidence suggests that the G7 Freedom Constrained Vivacit-E Liners are effective for hip replacement?

This trial will evaluate the G7 Freedom Constrained Vivacit-E Liners in hip replacement surgeries. Studies have shown that these liners improve hip implants by enhancing fit and movement, potentially leading to better patient outcomes. Research indicates that they can simplify surgeries and offer long-lasting results. Initial findings suggest these liners benefit both first-time and follow-up hip surgeries, ensuring the hip replacement functions well over time, which is crucial for maintaining an active lifestyle. ^{1 2 4 5 6}

Who Is on the Research Team?

Hillary Overholser

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with joint diseases like osteoarthritis or avascular necrosis, rheumatoid arthritis, high risk of hip dislocation, or those needing revision hip surgery. It's also for patients with certain types of hip fractures that can't be treated by other methods. Participants must be able to follow the study plan and give informed consent.

Inclusion Criteria

My bones have stopped growing.

Patient qualifies for unilateral total hip arthroplasty based on physical exam and medical history including at least one of the following: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; High risk for dislocation; Undergoing revision hip arthroplasty; Correction of functional deformity; In need of treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques; Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent; Patient, or the patient's legally authorized representative, has participated in the Informed Consent process and is willing and able to sign an IRB approved informed consent

Exclusion Criteria

I had or will have hip replacement surgery on the opposite side within 3 months.

My X-rays show fast joint damage or significant bone loss.

I have poor blood flow, muscle loss, or nerve disease at the surgery site.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty

Varies

Follow-up

Participants are monitored for safety, performance, and clinical benefits, including radiographic evaluations and patient-reported outcomes

10 years

What Are the Treatments Tested in This Trial?

Interventions

• G7 Freedom Constrained Vivacit-E Liners

Trial Overview The trial is testing G7 Freedom Constrained Vivacit-E Liners in total hip replacements to see if they're safe and effective over the long term. This includes both first-time surgeries and revisions (re-doing previous surgeries).

How Is the Trial Designed?

Group I: Total Hip Arthroplasty Treatment Group Experimental Treatment 1 Intervention

This study will enroll (implant) up to 202 hips in total according to the IFU and surgical technique. Of these, up to 135 will be revision hips and up to 67 will be primary hips. This is a dual cohort study (primary and revision); each subject will receive the G7 Acetabular System with the Freedom Constrained Vivacit-E bearing. To minimize potential bias and to maximize our ability to assess inter-site differences, each study site will target up to 27 primary hip arthroplasties and up to 54 revision hip arthroplasties (not exceed 81 implanted hips or 40% of total study population). Each site is encouraged to enroll (implant) both primary and revision subjects.

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05587244?term=AREA%5BBasicSearch%5D(vivacit)&rank=1

NCT05587244 | G7 Freedom Constrained Vivacit-E Liners The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit -E Acetabular ...

2. zimmerbiomet.com zimmerbiomet.com/en/products-and-solutions/specialties/hip/g7-acetabular-system.html

G7® Acetabular System The G7 Acetabular System is specifically designed to simplify implant and instrument delivery for optimized operative efficiency and maximized clinical ...

3. clinicaltrial.be clinicaltrial.be/en/details/287245?only_active=0&only_eligible=0&only_recruiting=0&per_page=20

G7 Freedom Constrained Vivacit-E Liners The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained ...

4. clinconnect.io clinconnect.io/trials/NCT05587244

G7 Freedom Constrained Vivacit-E Liners (NCT05587244) The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular ...

5. ufhealth.org ufhealth.org/clinical-trials/zimmer-biomet-g7-liners

Zimmer Biomet G7 Liners The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular ...

6. ctv.veeva.com ctv.veeva.com/study/g7-freedom-constrained-vivacit-e-liners

G7 Freedom Constrained Vivacit-E Liners - ClinicalTrials.Veeva The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit- ...